A government study about the costs of providing oxygen therapy in the home is deeply flawed according to the American Association for Homecare. Moreover, the further erosion of the oxygen benefit recommended by the report and by CMS will put oxygen patients at even greater risk than they are already, says the Association.
On September 14, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a study about the cost of home oxygen under Medicare. The American Association for Homecare cited a 2006 study it commissioned from Morrison Informatics as a more accurate analysis of the costs of oxygen therapy provided in the home.
The American Association for Homecare expressed appreciation for the visits the OIG made to oxygen providers, patients, and referral sources. However, the OIG study does not reflect the full range of services provided to patients nor does it reflect the actual costs incurred in providing them. Moreover, the OIG looks at old cost data, from 2003. The Morrison Informatics study reviewed all current oxygen-related services for 2006.
The Association cited several areas of concern regarding the OIG study:
-- The study focuses primarily on the cost of acquiring oxygen concentrators, which is a small fraction of the complete cost of providing oxygen therapy to Medicare patients in the home. (The Morrison study shows that equipment costs represent only 28 percent of the total cost of providing oxygen therapy.) The OIG study does not consider the full range of services and costs required in providing oxygen therapy.
-- OIG notes that other costs were not considered because they are included in the fee schedule amounts that are based on historical reimbursement levels of nearly 20 years ago. During recent decades, transportation, regulatory compliance, insurance, and other costs have increased while oxygen reimbursement under Medicare has declined sharply.
-- The OIG study only asked for cost information about oxygen concentrators. The study should have looked at all types of oxygen modalities including liquid and the full costs of portable oxygen systems.It did not collect data about the acquisition cost for all of the portable tanks, regulators, oxygen conserving devices, cannulas, tubing, and other tangible equipment and supplies provided to home oxygen patients.
-- The report does not consider average delivery cost per patient, average miles driven, average customer service time, bad debt, or Medicare-required documentation and compliance costs. An accurate accounting of costs should acknowledge that healthcare reimbursements should factor in rent, utilities, insurance and other costs, which are considered in other healthcare sectors.
-- The OIG study gathered information only about new users of oxygen who began services in 2004 and who had no services previous to that year. Because COPD is a progressive disease, new users often start with nocturnal use only, and longer-term patients require more service.
-- The OIG presented data that suggests that all patients rent oxygen for 36 months. Their own data shows that 78 percent never reach the 36th month.
-- The 145 patients in the sample represent about one one-hundredth of one percent of total beneficiaries using oxygen therapy at home.
The Morrison Study Commissioned by the American Association for Homecare
Earlier this year, the American Association for Homecare commissioned a study by Morrison Informatics to study the costs of providing oxygen therapy in the home. Morrison collected and analyzed data from homecare providers that collectively serve more than 600,000 Medicare beneficiaries receiving oxygen therapy in their homes, which represents more than half of the Medicare population receiving oxygen therapy at home.
The study found that nearly three-quarters (72 percent) of the cost of providing home oxygen therapy to Medicare patients in their homes represent services, delivery, and other operational expenses that benefit patients. Only about one-quarter (28 percent) of the cost represents oxygen equipment.
?"It is time that CMS and Congress recognize that the services captured in this Morrison study represent the industry standard of care in the United States, regardless of the payor source - managed care, Medicaid, and Medicare patients alike all require the same service categories," commented Tom Ryan, Chairman of the American Association for Homecare and CEO of Homecare Concepts in Farmingdale, NY.
Oxygen Therapy
Medical oxygen and oxygen systems require a physician's prescription. Oxygen is highly regulated by the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration, and the U.S. Department of Transportation.
Oxygen therapy is critical to approximately one million Americans who suffer from respiratory illnesses such as COPD and who require oxygen therapy under Medicare. Nationwide, as many as 15 million Americans have been diagnosed with COPD, which is growing in prevalence. It is a slowly progressive, incurable disease that causes irreversible loss of lung function. Though existing medications have not proven beneficial in reversing its effects, home oxygen therapy-when properly prescribed and maintained-can slow or stop lung degeneration.
Congressional Action on Oxygen Issues
The American Association for Homecare has endorsed the Home Oxygen Patient Protection Act, H.R. 5513, which was introduced in May by two physicians in Congress - Rep. Joe Schwarz (R-Mich.) and Rep. Tom Price (R-Ga.) along with other members of Congress and its Senate companion bill, S. 3814, introduced by Sen. Pat Roberts (R-Kan.) and Sen. Jack Reed (D-R.I.). The bill restores the Medicare treatment of ownership of oxygen equipment to that in effect before enactment of the Deficit Reduction Act of 2005 (DRA). A provision in the DRA forces oxygen users to assume ownership of and responsibility for the oxygen system they use after 36 months. The DRA policy change effectively severs the patient-provider relationship for home oxygen therapy, which raises numerous patient-safety concerns.
The American Association for Homecare, the American Lung Association, and other patient and provider groups vigorously oppose the change in oxygen policy. Medical oxygen therapy at home costs an average of $7.62 per day under Medicare. The average hospital cost under Medicare is $4,603 per day.
"We believe that Congress inadvertently overlooked important patient and public safety concerns associated with home oxygen therapy, and that the new oxygen equipment ownership provisions may actually conflict with existing FDA regulations," said Ryan. "A national Medicare policy that does not account for the many services associated with oxygen therapy shortchanges both the patient and the provider. As a result, up to a million Medicare patients who require medical oxygen may find breathing even harder than it already is."
Ryan continued, "Home oxygen reimbursements under Medicare have been cut by nearly 50 percent over the past decade. This direction in policy will shrink and erode the nation's homecare infrastructure, which delivers high-quality, cost-effective care to a growing population of older Americans."
In a letter to Members of Congress earlier this year, American Lung Association President John Kirkwood said that the DRA provision raises many quality of care, continuity of care and patient out-of-pocket costs issues that may have significant impact on the lives of people with lung disease. "The American Lung Association is deeply troubled that Congress is acting precipitously without enough information to inform lung disease patients of the impact of these proposed changes," Kirkwood wrote. "We urge Congress to ensure these changes will not adversely impact patient health, interrupt continuity of care or shift additional costs to patients and their families."
The American Association for Homecare (AAHomecare) is the only national association that represents every line of service in the homecare community, including home medical equipment providers, respiratory therapy, infusion therapy, rehab and assistive technology, home health agencies, home hospice, and telemedicine. AAHomecare represents more than 3,000 member locations nationwide. For details about home oxygen therapy, see aahomecare.
воскресенье, 15 мая 2011 г.
New Study Demonstrates Rapid Speed Of Onset With Budesonide/formoterol In COPD
New data from a study investigating the
onset of action with respect to airway dilatation in budesonide/formoterol
(Symbicort(R)), salmeterol/fluticasone (SeretideT), salbutamol and placebo
were announced today at the European Respiratory Society 2006 Annual
Congress (ERS)1. The data show that budesonide/formoterol has an onset of
action that is similar to that of salbutamol and faster than that of
salmeterol/fluticasone in patients with COPD.
"Speed of onset is as important in COPD as it is in asthma, especially in
the morning when patients often require a rapid onset of bronchodilatory
effect. Rapid symptom relief from a maintenance treatment will most likely
also provide improved compliance. Therefore the data presented today is very
interesting and adds to our understanding of the role of
budesonide/formoterol in treatment of COPD," said Professor Martyn R.
Partridge, Faculty of Medicine, Imperial College London.
In the double-blind, double-dummy, placebo-controlled crossover study, 88
patients were randomised to four treatments to receive either single doses
of budesonide/formoterol, salmeterol/fluticasone, salbutamol or placebo in
order to compare the onset of action in patients with COPD. Treatments were
administered via pressurised metered dose inhalers (pMDI)*. The primary
endpoint was an improvement in airway dilatation measured by a change in
FEV1 at 5 minutes after inhalation.
The study showed that budesonide/formoterol improved FEV1 to a greater
extent than placebo and that the onset of effect with budesonide/formoterol
was similar to that seen with reliever therapy salbutamol and faster than
salmeterol/fluticasone. Maximal effect on Inspiratory Capacity, regarded as
predictor of exercise tolerance, was greater with budesonide/formoterol as
compared to salmeterol/fluticasone. Improvement in lung function parameters
for all three active treatments was superior to placebo after 180 minutes,
but the two combination treatments were better than the SABA alone at
maintaining the improvement in FEV1.
"Speed of onset is as important in COPD as it is in asthma, especially in
the morning when patients often require a rapid onset of bronchodilatory
effect. The findings from the study confirm that rapid onset of action can
also be exerted by maintenance therapies in COPD," concluded Martyn R.
Partridge.
* Budesonide/formoterol is licensed for use in COPD patients with an
FEV1
onset of action with respect to airway dilatation in budesonide/formoterol
(Symbicort(R)), salmeterol/fluticasone (SeretideT), salbutamol and placebo
were announced today at the European Respiratory Society 2006 Annual
Congress (ERS)1. The data show that budesonide/formoterol has an onset of
action that is similar to that of salbutamol and faster than that of
salmeterol/fluticasone in patients with COPD.
"Speed of onset is as important in COPD as it is in asthma, especially in
the morning when patients often require a rapid onset of bronchodilatory
effect. Rapid symptom relief from a maintenance treatment will most likely
also provide improved compliance. Therefore the data presented today is very
interesting and adds to our understanding of the role of
budesonide/formoterol in treatment of COPD," said Professor Martyn R.
Partridge, Faculty of Medicine, Imperial College London.
In the double-blind, double-dummy, placebo-controlled crossover study, 88
patients were randomised to four treatments to receive either single doses
of budesonide/formoterol, salmeterol/fluticasone, salbutamol or placebo in
order to compare the onset of action in patients with COPD. Treatments were
administered via pressurised metered dose inhalers (pMDI)*. The primary
endpoint was an improvement in airway dilatation measured by a change in
FEV1 at 5 minutes after inhalation.
The study showed that budesonide/formoterol improved FEV1 to a greater
extent than placebo and that the onset of effect with budesonide/formoterol
was similar to that seen with reliever therapy salbutamol and faster than
salmeterol/fluticasone. Maximal effect on Inspiratory Capacity, regarded as
predictor of exercise tolerance, was greater with budesonide/formoterol as
compared to salmeterol/fluticasone. Improvement in lung function parameters
for all three active treatments was superior to placebo after 180 minutes,
but the two combination treatments were better than the SABA alone at
maintaining the improvement in FEV1.
"Speed of onset is as important in COPD as it is in asthma, especially in
the morning when patients often require a rapid onset of bronchodilatory
effect. The findings from the study confirm that rapid onset of action can
also be exerted by maintenance therapies in COPD," concluded Martyn R.
Partridge.
* Budesonide/formoterol is licensed for use in COPD patients with an
FEV1
Spiriva(R) Consistently Reduces Exacerbations And Associated Hospitalisations In Patients With COPD - Meta-Analysis Of Clinical Studies Shows
Patients with chronic obstructive pulmonary disease (COPD) treated with Spiriva(R) (tiotropium) for 6-12 months experienced significantly fewer exacerbations and hospitalisations compared with patients receiving placebo according to an analysis of pooled studies presented today at the International Conference of the American Thoracic Society (ATS).1 Spiriva(R) is the first and only once-daily, inhaled anticholinergic medication for maintenance treatment of COPD.
COPD is a progressive respiratory illness that causes significant deterioration of lung function and chronic breathlessness.2 600 million people worldwide already live with COPD, but its prevalence is predicted to rise to become the world's third leading cause of death by 2020.3,4 COPD exacerbations, or an acute worsening of disease symptoms, may accelerate the progression of COPD.2
"These results underline the benefit of effective treatment for patients who suffer with COPD and exacerbations," said Dr David Halpin, Consultant Physician and Senior Lecturer in Respiratory Medicine at the Royal Devon and Exeter Hospital, UK, and study investigator of the pooled analysis. "Exacerbations of COPD significantly reduce a patient's quality of life, and are a major cause of hospitalisation, disability and death. Preventing and treating exacerbations is a key goal of COPD management."
The post hoc analysis was performed on nine, completed, randomised, placebo-controlled, parallel-group Spiriva(R) studies with a duration of six months to one year.
Exacerbations were uniformly defined across all studies as an increase in, or new onset of at least two of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of three days requiring requiring treatment with antibiotics or systemic steroids, or hospitalisation. 6,171 COPD patients were included in the analysis.
Results showed, compared with placebo1:
-- Spiriva(R) significantly reduced the exposure-adjusted incidence rate of COPD exacerbations by 22.6% (65.8 vs. 85.0 per 100 patient-years; p
The Spiriva(R) clinical trials programme has recruited over 25,000 patients.7 Spiriva(R) has demonstrated significant and sustained bronchodilation (opening of the airways)6,8 and reduction in markers of hyperinflation (air trapping).9,10 Spiriva(R) also demonstrated superior and sustained improvements in lung function (FEV1) over ATROVENT(R) (ipratropium bromide) Inhalation Aerosol, a current first-line therapy for COPD, which were maintained over one year6 and has also demonstrated superior improvement in key lung function parameters over salmeterol.11 In addition, in placebo-controlled studies, patients treated with Spiriva(R) had less activity-induced breathlessness and improved exercise endurance. They required fewer doses of rescue medications, had fewer exacerbations and COPD-related hospitalizations.8 In clinical trials, the most common adverse reaction reported with Spiriva(R) was dry mouth, which was usually mild and often resolved during treatment.6,8
According to treatment guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), long-acting beta-2-agonists and tiotropium, are a preferred treatment option for COPD maintenance therapy.12
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and almost 37,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development.
* Exposure was defined as the cumulative time patients participated in the study from randomisation until the onset of exacerbation, or until discontinuation of treatment.
References
1 Halpin D, Menjoge S, Dusser D, et al. Pooled analysis of effect of tiotropium on COPD exacerbations and related hospitalisations. Abstract presented at ATS 2006, San Diego, USA. 19-24 May 2006.
2 Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. Executive Summary. GOLD website (goldcopd). Updated 2005.
3 World Health Organization. World Health Report 2004. Statistical Annex. Annex table 2 and 3: 120-131.
4 Murray CJL, Lopez AD. eds. The Global Burden of Disease: a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020. Cambridge; Harvard University Press; 1996.
5 Casaburi R, Kukafka D, Cooper CB, et al. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest 2005; 127:809-817.
6 Vincken W, van Noord JA, Greefhorst APM, et al. Improved health outcomes in patients with COPD during 1 year's treatment with tiotopium. Eur Respir J 2002; 19:209-216.
7 Boehringer Ingelheim. Data on file.
8 Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J. 2002;1:217-224.
9 Celli B, ZuWallack R, Wang S, et al. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest 2003; 124:1743-1748.
10 O`Donnell DE, Fluge T, Gerken F, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J. 2004 23(6):832-48
11 Brusasco V, Hodder R, Miravitlles M, et al. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax 2003;58:399-404.
12 Pocket Guide to COPD diagnosis, management, and prevention - A guide for healthcare professionals. Global Initiative for Chronic Obstructive Lung Disease. Available at: goldcopd
boehringer-ingelheim
COPD is a progressive respiratory illness that causes significant deterioration of lung function and chronic breathlessness.2 600 million people worldwide already live with COPD, but its prevalence is predicted to rise to become the world's third leading cause of death by 2020.3,4 COPD exacerbations, or an acute worsening of disease symptoms, may accelerate the progression of COPD.2
"These results underline the benefit of effective treatment for patients who suffer with COPD and exacerbations," said Dr David Halpin, Consultant Physician and Senior Lecturer in Respiratory Medicine at the Royal Devon and Exeter Hospital, UK, and study investigator of the pooled analysis. "Exacerbations of COPD significantly reduce a patient's quality of life, and are a major cause of hospitalisation, disability and death. Preventing and treating exacerbations is a key goal of COPD management."
The post hoc analysis was performed on nine, completed, randomised, placebo-controlled, parallel-group Spiriva(R) studies with a duration of six months to one year.
Exacerbations were uniformly defined across all studies as an increase in, or new onset of at least two of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of three days requiring requiring treatment with antibiotics or systemic steroids, or hospitalisation. 6,171 COPD patients were included in the analysis.
Results showed, compared with placebo1:
-- Spiriva(R) significantly reduced the exposure-adjusted incidence rate of COPD exacerbations by 22.6% (65.8 vs. 85.0 per 100 patient-years; p
The Spiriva(R) clinical trials programme has recruited over 25,000 patients.7 Spiriva(R) has demonstrated significant and sustained bronchodilation (opening of the airways)6,8 and reduction in markers of hyperinflation (air trapping).9,10 Spiriva(R) also demonstrated superior and sustained improvements in lung function (FEV1) over ATROVENT(R) (ipratropium bromide) Inhalation Aerosol, a current first-line therapy for COPD, which were maintained over one year6 and has also demonstrated superior improvement in key lung function parameters over salmeterol.11 In addition, in placebo-controlled studies, patients treated with Spiriva(R) had less activity-induced breathlessness and improved exercise endurance. They required fewer doses of rescue medications, had fewer exacerbations and COPD-related hospitalizations.8 In clinical trials, the most common adverse reaction reported with Spiriva(R) was dry mouth, which was usually mild and often resolved during treatment.6,8
According to treatment guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), long-acting beta-2-agonists and tiotropium, are a preferred treatment option for COPD maintenance therapy.12
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and almost 37,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development.
* Exposure was defined as the cumulative time patients participated in the study from randomisation until the onset of exacerbation, or until discontinuation of treatment.
References
1 Halpin D, Menjoge S, Dusser D, et al. Pooled analysis of effect of tiotropium on COPD exacerbations and related hospitalisations. Abstract presented at ATS 2006, San Diego, USA. 19-24 May 2006.
2 Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. Executive Summary. GOLD website (goldcopd). Updated 2005.
3 World Health Organization. World Health Report 2004. Statistical Annex. Annex table 2 and 3: 120-131.
4 Murray CJL, Lopez AD. eds. The Global Burden of Disease: a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020. Cambridge; Harvard University Press; 1996.
5 Casaburi R, Kukafka D, Cooper CB, et al. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest 2005; 127:809-817.
6 Vincken W, van Noord JA, Greefhorst APM, et al. Improved health outcomes in patients with COPD during 1 year's treatment with tiotopium. Eur Respir J 2002; 19:209-216.
7 Boehringer Ingelheim. Data on file.
8 Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J. 2002;1:217-224.
9 Celli B, ZuWallack R, Wang S, et al. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest 2003; 124:1743-1748.
10 O`Donnell DE, Fluge T, Gerken F, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J. 2004 23(6):832-48
11 Brusasco V, Hodder R, Miravitlles M, et al. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax 2003;58:399-404.
12 Pocket Guide to COPD diagnosis, management, and prevention - A guide for healthcare professionals. Global Initiative for Chronic Obstructive Lung Disease. Available at: goldcopd
boehringer-ingelheim
Positive Results Of Clinical Studies For Aclidinium Bromide, A Novel Long-Acting Anticholinergic For The Treatment For COPD
Laboratorios Almirall, S.A. and Forest Laboratories, Inc. presented
results from four clinical trials assessing the efficacy and
safety of aclidinium bromide, an investigational treatment for chronic
obstructive pulmonary disease (COPD). Data from four preclinical studies
further describing the properties of aclidinium were also presented at the
meeting.
Presentations included data from a 464-patient randomized,
double-blind, four-week, Phase IIb study that evaluated both the efficacy and
tolerability of once-daily aclidinium (25 mcg, 50 mcg, 100 mcg, 200 mcg or
400 mcg) or placebo in patients with moderate to severe COPD. An open-label
tiotropium (18 mcg) arm was included as an active control. The study
demonstrated aclidinium (200 mcg and 400 mcg), administered via a multi-dose
dry powder inhaler, significantly increased trough (24 hour) forced
expiratory volume in one second (FEV1) - an important measure of lung
function - on Day 29 compared with placebo (p
"There are still significant unmet needs in the treatment of
COPD. These efficacy and safety data from the Phase II trials are very
encouraging," said Lawrence S. Olanoff, M.D., Ph.D., President and Chief
Operating Officer of Forest Laboratories. "We look forward to the completion
of ACCLAIM I & II trials and continuing the clinical development of
aclidinium for the treatment of COPD."
Results of pre-clinical animal and in vitro studies announced
at the meeting showed that aclidinium exhibited low potential for
cardiovascular effects and was broken down in the plasma within 1.8 to 38
minutes, across the models studied.(5) In addition, aclidinium had a potent
and long-lasting effect on preventing bronchoconstriction in both the human
bronchi and several animal models assessed. (6),(7)
Abstracts from ATS 2008 will be available upon request.
About Aclidinium Bromide
Aclidinium bromide is a novel inhaled anticholinergic
bronchodilator that is currently in phase III clinical development as a
once-daily maintenance treatment for COPD. Almirall licensed US rights to
aclidinium to Forest Laboratories, whilst keeping rights for the rest of the
world. The companies are jointly involved in the development of the compound.
About COPD
COPD is a preventable and treatable lung disease characterized
by chronic airflow limitation that interferes with normal breathing and is
not fully reversible.(8) Globally, an estimated 80 million people have
moderate to severe COPD. In excess of 3 million people died of the condition
in 2005, accounting for 5% of all deaths worldwide.(9)
About Almirall
Almirall, an international pharmaceutical company based on
innovation and committed to health, headquartered in Barcelona, Spain,
researches, develops, manufactures and commercialises its own R&D and
licensed drugs with the aim of improving people's health and wellbeing.
The therapeutic areas on which Almirall focuses its research
resources are related to the treatment of COPD (Chronic Obstructive Pulmonary
Disease), asthma, psoriasis, rheumatoid arthritis and multiple sclerosis.
Almirall's medicines are currently present in over 70
countries with direct presence in Europe and Latin America.
almirall
About Forest Laboratories
Forest Laboratories is a U.S.-based pharmaceutical company dedicated to
identifying, developing, and delivering products that make a positive
difference in people's lives. Forest Laboratories' growing product line
includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for
the initial and maintenance treatment of major depressive disorder and
generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment
of moderate to severe Alzheimer's disease; Campral(R)* (acamprosate calcium),
indicated in combination with psychosocial support for the maintenance of
abstinence from alcohol in patients with alcohol dependence who are abstinent
at treatment initiation; and Bystolic(R) (nebivolol), a beta-adrenergic
receptor blocking agent indicated for the treatment of hypertension. For more
information, visit frx.
* Campral is a registered trademark of Merck Sant?© s.a.s., a subsidiary
of Merck KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and launch
of new products, and the risk factors listed from time to time in Forest
Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and
any subsequent SEC filings.
References
(1) Chanez P, Burge S, Dahl R, et al. Once-daily administration of
aclidinium bromide, a novel, long-acting anticholinergic: a Phase II, dose
finding study. American Thoracic Society, May 2008. Poster.
(2) Lasseter KC, Aubets J, Gil E Garcia. Aclidinium bromide, a novel
long-acting anticholingergic, does not affect QT interval in health subjects.
American Thoracic Society, May 2008. Poster.
(3) Ferrer P, Jansat JM, Gil E Garcia. Pharmokinetics and safety of
aclidinium bromide, a novel long-acting, inhaled anticholinergic, in healthy
subjects. American Thoracic Society, May 2008. Poster.
(4) De Miquel G, Schr?¶dter A, Miletzki B, et al. Low systemic exposure to
aclidinium bromide, a novel long-acting anticholinergic, after multiple
doses. American Thoracic Society, May 2008. Poster.
(5) Gras J, Gavald? A, Llenas J. The preclinical cardiovascular safety
profile of aclidinium bromide, a novel long-acting anticholinergic drug.
American Thoracic Society, May 2008. Poster.
(6) Miralpeix M, Otal R, Carre?±o C, et al. Aclidinium bromide, a novel
anti-muscarinic, reverses cholinergic-induced bronchoconstriction with a fast
onset of action and a long-lasting effect in guinea pigs. American Thoracic
Society, May 2008. Poster.
(7) Cortijo J, Sarri?? B, Gavald? A. In vitro characterization of
aclidinium bromide, a novel long-acting anticholinergic: effects on isolated
human bronchi. American Thoracic Society, May 2008. Poster.
(8) Global Initiative for Chronic Obstructive Lung Disease. Global
strategy for diagnosis, management, prevention of COPD
(goldcopd) accessed 3 September 2007.
(9) World Health Organisation (WHO). Chronic obstructive pulmonary
disease (COPD). Factsheet number 315; November 2006.
almirall
View drug information on Campral.
results from four clinical trials assessing the efficacy and
safety of aclidinium bromide, an investigational treatment for chronic
obstructive pulmonary disease (COPD). Data from four preclinical studies
further describing the properties of aclidinium were also presented at the
meeting.
Presentations included data from a 464-patient randomized,
double-blind, four-week, Phase IIb study that evaluated both the efficacy and
tolerability of once-daily aclidinium (25 mcg, 50 mcg, 100 mcg, 200 mcg or
400 mcg) or placebo in patients with moderate to severe COPD. An open-label
tiotropium (18 mcg) arm was included as an active control. The study
demonstrated aclidinium (200 mcg and 400 mcg), administered via a multi-dose
dry powder inhaler, significantly increased trough (24 hour) forced
expiratory volume in one second (FEV1) - an important measure of lung
function - on Day 29 compared with placebo (p
"There are still significant unmet needs in the treatment of
COPD. These efficacy and safety data from the Phase II trials are very
encouraging," said Lawrence S. Olanoff, M.D., Ph.D., President and Chief
Operating Officer of Forest Laboratories. "We look forward to the completion
of ACCLAIM I & II trials and continuing the clinical development of
aclidinium for the treatment of COPD."
Results of pre-clinical animal and in vitro studies announced
at the meeting showed that aclidinium exhibited low potential for
cardiovascular effects and was broken down in the plasma within 1.8 to 38
minutes, across the models studied.(5) In addition, aclidinium had a potent
and long-lasting effect on preventing bronchoconstriction in both the human
bronchi and several animal models assessed. (6),(7)
Abstracts from ATS 2008 will be available upon request.
About Aclidinium Bromide
Aclidinium bromide is a novel inhaled anticholinergic
bronchodilator that is currently in phase III clinical development as a
once-daily maintenance treatment for COPD. Almirall licensed US rights to
aclidinium to Forest Laboratories, whilst keeping rights for the rest of the
world. The companies are jointly involved in the development of the compound.
About COPD
COPD is a preventable and treatable lung disease characterized
by chronic airflow limitation that interferes with normal breathing and is
not fully reversible.(8) Globally, an estimated 80 million people have
moderate to severe COPD. In excess of 3 million people died of the condition
in 2005, accounting for 5% of all deaths worldwide.(9)
About Almirall
Almirall, an international pharmaceutical company based on
innovation and committed to health, headquartered in Barcelona, Spain,
researches, develops, manufactures and commercialises its own R&D and
licensed drugs with the aim of improving people's health and wellbeing.
The therapeutic areas on which Almirall focuses its research
resources are related to the treatment of COPD (Chronic Obstructive Pulmonary
Disease), asthma, psoriasis, rheumatoid arthritis and multiple sclerosis.
Almirall's medicines are currently present in over 70
countries with direct presence in Europe and Latin America.
almirall
About Forest Laboratories
Forest Laboratories is a U.S.-based pharmaceutical company dedicated to
identifying, developing, and delivering products that make a positive
difference in people's lives. Forest Laboratories' growing product line
includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for
the initial and maintenance treatment of major depressive disorder and
generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment
of moderate to severe Alzheimer's disease; Campral(R)* (acamprosate calcium),
indicated in combination with psychosocial support for the maintenance of
abstinence from alcohol in patients with alcohol dependence who are abstinent
at treatment initiation; and Bystolic(R) (nebivolol), a beta-adrenergic
receptor blocking agent indicated for the treatment of hypertension. For more
information, visit frx.
* Campral is a registered trademark of Merck Sant?© s.a.s., a subsidiary
of Merck KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and launch
of new products, and the risk factors listed from time to time in Forest
Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and
any subsequent SEC filings.
References
(1) Chanez P, Burge S, Dahl R, et al. Once-daily administration of
aclidinium bromide, a novel, long-acting anticholinergic: a Phase II, dose
finding study. American Thoracic Society, May 2008. Poster.
(2) Lasseter KC, Aubets J, Gil E Garcia. Aclidinium bromide, a novel
long-acting anticholingergic, does not affect QT interval in health subjects.
American Thoracic Society, May 2008. Poster.
(3) Ferrer P, Jansat JM, Gil E Garcia. Pharmokinetics and safety of
aclidinium bromide, a novel long-acting, inhaled anticholinergic, in healthy
subjects. American Thoracic Society, May 2008. Poster.
(4) De Miquel G, Schr?¶dter A, Miletzki B, et al. Low systemic exposure to
aclidinium bromide, a novel long-acting anticholinergic, after multiple
doses. American Thoracic Society, May 2008. Poster.
(5) Gras J, Gavald? A, Llenas J. The preclinical cardiovascular safety
profile of aclidinium bromide, a novel long-acting anticholinergic drug.
American Thoracic Society, May 2008. Poster.
(6) Miralpeix M, Otal R, Carre?±o C, et al. Aclidinium bromide, a novel
anti-muscarinic, reverses cholinergic-induced bronchoconstriction with a fast
onset of action and a long-lasting effect in guinea pigs. American Thoracic
Society, May 2008. Poster.
(7) Cortijo J, Sarri?? B, Gavald? A. In vitro characterization of
aclidinium bromide, a novel long-acting anticholinergic: effects on isolated
human bronchi. American Thoracic Society, May 2008. Poster.
(8) Global Initiative for Chronic Obstructive Lung Disease. Global
strategy for diagnosis, management, prevention of COPD
(goldcopd) accessed 3 September 2007.
(9) World Health Organisation (WHO). Chronic obstructive pulmonary
disease (COPD). Factsheet number 315; November 2006.
almirall
View drug information on Campral.
Flu Vaccines Can Reduce Respiratory Problems By Up To Three-Quarters
Annual flu vaccinations are highly effective at preventing acute respiratory illness and
making sure that existing breathing problems don't get any worse, according to
research published in the April issue of IJCP, the UK-based International Journal of
Clinical Practice.
A study of 87 patients with chronic obstructive pulmonary disease (COPD) - a major
cause of ill health and death - found that having the annual flu vaccine reduced
overall problems by more than two-thirds.
The vaccinations were particularly effective at providing protection for patients with
severe COPD, where the incidence of additional respiratory problems fell by threequarters.
"COPD is a serious lung disease that causes breathing problems and is responsible
for a significant number of outpatient and emergency department visits as well as
inpatient hospital stays" says lead author Dr Balakrishnan Menon from the
Vallabhbhai Patel Chest Institute at the University of Delhi, India.
"It has increased by 40 per cent since 1942 and is now the world's fourth leading
cause of death and twelfth leading cause of disability. The World Health Organization
(WHO) predicts that by 2020 it will become the third leading cause of death and rise
significantly in the disability stakes to fifth place.
"Most of the healthcare costs associated with COPD are due to problems that worsen
the condition and infections caused by the influenza virus are major culprits.
"Despite the WHO's recommendation that all patients with COPD should receive the
annual flu vaccine, the injection is not used as widely as it could be, especially in
developing countries.
"Our research suggests that this could be leading to higher levels of respiratory
problems and that these extra healthcare costs could be avoided by improving the
uptake of this simple preventative measure."
The 87 male patients, who had an average age of just under 65, were monitored for
a year before and after they received the vaccine. All had been diagnosed with
COPD, but none of them had previously received the flu vaccine.
After the patients received the vaccine, the overall incidence of acute respiratory
illness and acute exacerbation of COPD fell by 67 per cent, with 24 patients
experiencing them before they received the vaccinee and eight experiencing them in
the post-vaccination period.
The effectiveness of the vaccine varied, depending on how badly people suffered
from the disease. People with mild or moderate COPD saw a 60 per cent reduction in
overall incidence and people with severe COPD enjoyed a 75 per cent reduction.
Outpatient visits fell by 50 per cent after vaccination and there was also a 70 per cent
reduction in the number of study participants who were hospitalised.
During the two-year study period patients attended monthly check-ups and received
the same level of medication, healthcare and lifestyle advice. Any respiratory
problems were also carefully monitored.
The researchers were careful to ensure that no other factors clouded the results so
that they could observe the effect of the influenza virus more efficiently. This included
having an all male study group. Fewer women met the study criteria, mainly because
they were less likely to smoke ??????" 83 per cent of the men in this study were current or
former smokers.
"Influenza viruses are a major cause of death and serious illness in elderly people,
particularly if they suffer from COPD" concludes Dr Menon.
"Our study was undertaken in a population where uptake of the vaccine is
traditionally low and it had a marked effect on the men who received it. This could
also explain why our 67 per cent reduction was higher than the 32 to 45 per cent falls
reported by previous studies carried out in populations where the vaccine is more
common.
"We believe that our research underlines the importance of increasing vaccine use
worldwide, especially in patients with COPD and in areas where the flu vaccination
rate is low.
"It is clear that annual flu vaccinations have a major role to play in bringing down the
number of preventable deaths and hospital admissions that occur every year in
patients with chronic lung diseases."
"Comparison of outpatient visits and hospitalisations in patients with chronic obstructive
pulmonary disease, before and after influenza vaccination". Menon et al. IJCP, the
International Journal of Clinical Practice. 62.4, pp 593-598.
IJCP, the International Journal of Clinical Practice was established in 1946 and is edited
by Dr Graham Jackson from Guy's and St Thomas' NHS Foundation Trust, London, UK.
It provides its global audience of clinicians with high-calibre clinical papers, including
original data from clinical investigations, evidence-based analysis and discussions on the
latest clinical topics. The journal is published by Blackwell Publishing Ltd, part of the
international Blackwell Publishing group. blackwellpublishing/ijcp
About Wiley-Blackwell
Wiley-Blackwell was formed in February 2007 as a result of the
acquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger with
Wiley's Scientific, Technical, and Medical business. Together, the companies have
created a global publishing business with deep strength in every major academic and
professional field. Wiley-Blackwell publishes approximately 1,400 scholarly peerreviewed
journals and an extensive collection of books with global appeal. For more
information on Wiley-Blackwell, please visit blackwellpublishing or
interscience.wiley
John Wiley & Sons, Inc.
making sure that existing breathing problems don't get any worse, according to
research published in the April issue of IJCP, the UK-based International Journal of
Clinical Practice.
A study of 87 patients with chronic obstructive pulmonary disease (COPD) - a major
cause of ill health and death - found that having the annual flu vaccine reduced
overall problems by more than two-thirds.
The vaccinations were particularly effective at providing protection for patients with
severe COPD, where the incidence of additional respiratory problems fell by threequarters.
"COPD is a serious lung disease that causes breathing problems and is responsible
for a significant number of outpatient and emergency department visits as well as
inpatient hospital stays" says lead author Dr Balakrishnan Menon from the
Vallabhbhai Patel Chest Institute at the University of Delhi, India.
"It has increased by 40 per cent since 1942 and is now the world's fourth leading
cause of death and twelfth leading cause of disability. The World Health Organization
(WHO) predicts that by 2020 it will become the third leading cause of death and rise
significantly in the disability stakes to fifth place.
"Most of the healthcare costs associated with COPD are due to problems that worsen
the condition and infections caused by the influenza virus are major culprits.
"Despite the WHO's recommendation that all patients with COPD should receive the
annual flu vaccine, the injection is not used as widely as it could be, especially in
developing countries.
"Our research suggests that this could be leading to higher levels of respiratory
problems and that these extra healthcare costs could be avoided by improving the
uptake of this simple preventative measure."
The 87 male patients, who had an average age of just under 65, were monitored for
a year before and after they received the vaccine. All had been diagnosed with
COPD, but none of them had previously received the flu vaccine.
After the patients received the vaccine, the overall incidence of acute respiratory
illness and acute exacerbation of COPD fell by 67 per cent, with 24 patients
experiencing them before they received the vaccinee and eight experiencing them in
the post-vaccination period.
The effectiveness of the vaccine varied, depending on how badly people suffered
from the disease. People with mild or moderate COPD saw a 60 per cent reduction in
overall incidence and people with severe COPD enjoyed a 75 per cent reduction.
Outpatient visits fell by 50 per cent after vaccination and there was also a 70 per cent
reduction in the number of study participants who were hospitalised.
During the two-year study period patients attended monthly check-ups and received
the same level of medication, healthcare and lifestyle advice. Any respiratory
problems were also carefully monitored.
The researchers were careful to ensure that no other factors clouded the results so
that they could observe the effect of the influenza virus more efficiently. This included
having an all male study group. Fewer women met the study criteria, mainly because
they were less likely to smoke ??????" 83 per cent of the men in this study were current or
former smokers.
"Influenza viruses are a major cause of death and serious illness in elderly people,
particularly if they suffer from COPD" concludes Dr Menon.
"Our study was undertaken in a population where uptake of the vaccine is
traditionally low and it had a marked effect on the men who received it. This could
also explain why our 67 per cent reduction was higher than the 32 to 45 per cent falls
reported by previous studies carried out in populations where the vaccine is more
common.
"We believe that our research underlines the importance of increasing vaccine use
worldwide, especially in patients with COPD and in areas where the flu vaccination
rate is low.
"It is clear that annual flu vaccinations have a major role to play in bringing down the
number of preventable deaths and hospital admissions that occur every year in
patients with chronic lung diseases."
"Comparison of outpatient visits and hospitalisations in patients with chronic obstructive
pulmonary disease, before and after influenza vaccination". Menon et al. IJCP, the
International Journal of Clinical Practice. 62.4, pp 593-598.
IJCP, the International Journal of Clinical Practice was established in 1946 and is edited
by Dr Graham Jackson from Guy's and St Thomas' NHS Foundation Trust, London, UK.
It provides its global audience of clinicians with high-calibre clinical papers, including
original data from clinical investigations, evidence-based analysis and discussions on the
latest clinical topics. The journal is published by Blackwell Publishing Ltd, part of the
international Blackwell Publishing group. blackwellpublishing/ijcp
About Wiley-Blackwell
Wiley-Blackwell was formed in February 2007 as a result of the
acquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger with
Wiley's Scientific, Technical, and Medical business. Together, the companies have
created a global publishing business with deep strength in every major academic and
professional field. Wiley-Blackwell publishes approximately 1,400 scholarly peerreviewed
journals and an extensive collection of books with global appeal. For more
information on Wiley-Blackwell, please visit blackwellpublishing or
interscience.wiley
John Wiley & Sons, Inc.
Study Results For Aclidinium Bromide, A Novel Anticholinergic, Presented At European Respiratory Society Annual Congress
Forest
Laboratories (NYSE: FRX) announced that single doses of inhaled
aclidinium produced a significant bronchodilatory response in 17 patients
with COPD according to results of a phase IIa trial presented today at the
European Respiratory Society (ERS) Annual Congress in Stockholm.(1)
Results of the study showed that mean FEV1 and FVC values - important
measures of lung function - were significantly increased with all studied
doses of aclidinium over a 24-hour time period, as compared to placebo.
Onset of significant bronchodilation was observed as early as 15 minutes
after aclidinium treatment and this effect was sustained for at least 24
hours. Forest licensed aclidinium, currently in phase III clinical trials
in COPD, from Spanish pharmaceutical company, Almirall.
Aclidinium was well-tolerated during the phase IIa trial and no
patients withdrew from the study because of adverse events. The majority of
adverse events reported were mild to moderate in intensity. The most
frequent drug- related adverse event observed was headache, which occurred
after both placebo and aclidinium treatment and was not dose-related.
Single doses of aclidinium did not result in any clinically significant
adverse effect on vital signs, heart function (as assessed by 12-lead ECG)
or laboratory data.
"Given the increasing disease burden of COPD in the US, there is a need
for new treatment options for patients suffering from this debilitating
disease," said Lawrence S. Olanoff, M.D., Ph.D., President and Chief
Operating Officer. "These phase II data reinforce our belief that
aclidinium has the potential to be a significant addition to the existing
armamentarium of COPD treatments."
Methodology
The phase IIa study of aclidinium was a two-center, double-blind,
randomized, ascending single-dose, placebo-controlled, cross-over trial
which enrolled 17 patients with moderate to severe COPD. Treatment was with
one of three doses of aclidinium (100 micrograms, 300 micrograms or 900
micrograms) or placebo-administered via dry-powder inhaler. The study's
primary outcome measure was area under the normalized curve (AUC) of FEV1
over a 24-hour time period.
Findings of a phase I single-dose study, also presented at ERS 2007,
demonstrate the bronchodilatory effects of aclidinium.(2) In the phase I
study, in 12 healthy volunteers, bronchoconstriction was induced with
methacholine challenge and then treated with one of three doses of
aclidinium. Aclidinium proved superior to placebo in improving specific
airway conductance. Aclidinium also provided statistically significant and
sustained protection against methacholine-induced airway constriction over
24 hours. Aclidinium was well-tolerated throughout the trial. Headache was
reported by two subjects and one subject experienced a serious adverse
event which was not considered to be related to study drug.
Results of preclinical studies also presented at the congress show
aclidinium's selectivity, long duration of action and rapid clearance from
the plasma.(3,4) When compared to other bronchodilatory agents in vitro,
aclidinium demonstrated potent anticholinergic activity comparable to both
tiotropium and ipratropium, but with a faster onset of action than
tiotropium and a significantly longer duration of action versus
ipratropium, allowing for 24- hour duration of action.(4)
About COPD
COPD is a preventable and treatable lung disease characterized by
chronic airflow limitation that is not fully reversible.(5) COPD is a
leading cause of death, illness, and disability in the United States, with
an estimated 10 million to 24 million adults in the US living with COPD.(6)
About Aclidinium Bromide
Aclidinium bromide is a novel inhaled anticholinergic bronchodilator
that is currently in phase III clinical development as a once-daily
maintenance treatment for COPD.
About Forest Laboratories and Its Products
Forest Laboratories (frx) is a US-based pharmaceutical company
dedicated to identifying, developing and delivering products that make a
positive difference in peoples' lives. Forest Laboratories' growing product
line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for
adults for the initial and maintenance treatment of major depressive
disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl D- aspartate (NMDA)-receptor antagonist indicated for the
treatment of moderate to severe Alzheimer's disease; Benicar(R)
(olmesartan medoxomil), an angiotensin receptor blocker, and Benicar
HCT(R) (olmesartan medoxomil - hydrochlorothiazide), an angiotensin
receptor blocker and diuretic combination product, each indicated for the
treatment of hypertension; and Campral(R) (acamprosate calcium), indicated
in combination with psychosocial support for the maintenance of abstinence
from alcohol in patients with alcohol dependence who are abstinent at
treatment initiation.
Benicar is a registered trademark of Daiichi Sankyo, Inc., and Campral
is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and
launch of new products, and the risk factors listed from time to time in
the Forest Laboratories' SEC reports, including the Company's Annual Report
on Form 10-K for the fiscal year ended March 31, 2007 and quarterly report
on form 10-Q for the period ended June 30, 2007.
References
1. Joos GF, Schelfhout VJ, Kanniess F et al. Bronchodilator effects of
aclidinium bromide, a novel long-acting anticholinergic, in COPD
patients: a phase II study. European Respiratory Society (ERS) Annual
Congress, September 2007. Poster.
2. Schelfhout VJ, Joos GF, Gil EG et al. Bronchodilator/bronchoprotective
effects of aclidinium bromide, a novel long-acting anticholinergic: a
phase I study. European Respiratory Society (ERS) Annual Congress,
September 2007. Poster.
3. Gavalda A, Miralpeix M, Ramos I et al. Aclidinium bromide, a novel
muscarinic receptor antagonist combining long residence at M3 receptors
and rapid plasma clearance. European Respiratory Society (ERS) Annual
Congress, September 2007. Poster.
4. Miralpeix M, Gavalda A, Morcillo E et al. Assessment of the potency and
duration of action of aclidinium bromide in guinea pig isolated trachea
in vitro. European Respiratory Society (ERS) Annual Congress, September
2007. Poster.
5. Global Initiative for Chronic Obstructive Lung Disease. Global strategy
for the diagnosis, management, and prevention of chronic obstructive
pulmonary disease; MCR Vision, Inc.; 2006
6. CDC, cdc/nceh/airpollution/copd/copdfaq.htm, accessed
September 11, 2007.
Forest Laboratories
frx
View drug information on Benicar; Campral.
Laboratories (NYSE: FRX) announced that single doses of inhaled
aclidinium produced a significant bronchodilatory response in 17 patients
with COPD according to results of a phase IIa trial presented today at the
European Respiratory Society (ERS) Annual Congress in Stockholm.(1)
Results of the study showed that mean FEV1 and FVC values - important
measures of lung function - were significantly increased with all studied
doses of aclidinium over a 24-hour time period, as compared to placebo.
Onset of significant bronchodilation was observed as early as 15 minutes
after aclidinium treatment and this effect was sustained for at least 24
hours. Forest licensed aclidinium, currently in phase III clinical trials
in COPD, from Spanish pharmaceutical company, Almirall.
Aclidinium was well-tolerated during the phase IIa trial and no
patients withdrew from the study because of adverse events. The majority of
adverse events reported were mild to moderate in intensity. The most
frequent drug- related adverse event observed was headache, which occurred
after both placebo and aclidinium treatment and was not dose-related.
Single doses of aclidinium did not result in any clinically significant
adverse effect on vital signs, heart function (as assessed by 12-lead ECG)
or laboratory data.
"Given the increasing disease burden of COPD in the US, there is a need
for new treatment options for patients suffering from this debilitating
disease," said Lawrence S. Olanoff, M.D., Ph.D., President and Chief
Operating Officer. "These phase II data reinforce our belief that
aclidinium has the potential to be a significant addition to the existing
armamentarium of COPD treatments."
Methodology
The phase IIa study of aclidinium was a two-center, double-blind,
randomized, ascending single-dose, placebo-controlled, cross-over trial
which enrolled 17 patients with moderate to severe COPD. Treatment was with
one of three doses of aclidinium (100 micrograms, 300 micrograms or 900
micrograms) or placebo-administered via dry-powder inhaler. The study's
primary outcome measure was area under the normalized curve (AUC) of FEV1
over a 24-hour time period.
Findings of a phase I single-dose study, also presented at ERS 2007,
demonstrate the bronchodilatory effects of aclidinium.(2) In the phase I
study, in 12 healthy volunteers, bronchoconstriction was induced with
methacholine challenge and then treated with one of three doses of
aclidinium. Aclidinium proved superior to placebo in improving specific
airway conductance. Aclidinium also provided statistically significant and
sustained protection against methacholine-induced airway constriction over
24 hours. Aclidinium was well-tolerated throughout the trial. Headache was
reported by two subjects and one subject experienced a serious adverse
event which was not considered to be related to study drug.
Results of preclinical studies also presented at the congress show
aclidinium's selectivity, long duration of action and rapid clearance from
the plasma.(3,4) When compared to other bronchodilatory agents in vitro,
aclidinium demonstrated potent anticholinergic activity comparable to both
tiotropium and ipratropium, but with a faster onset of action than
tiotropium and a significantly longer duration of action versus
ipratropium, allowing for 24- hour duration of action.(4)
About COPD
COPD is a preventable and treatable lung disease characterized by
chronic airflow limitation that is not fully reversible.(5) COPD is a
leading cause of death, illness, and disability in the United States, with
an estimated 10 million to 24 million adults in the US living with COPD.(6)
About Aclidinium Bromide
Aclidinium bromide is a novel inhaled anticholinergic bronchodilator
that is currently in phase III clinical development as a once-daily
maintenance treatment for COPD.
About Forest Laboratories and Its Products
Forest Laboratories (frx) is a US-based pharmaceutical company
dedicated to identifying, developing and delivering products that make a
positive difference in peoples' lives. Forest Laboratories' growing product
line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for
adults for the initial and maintenance treatment of major depressive
disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl D- aspartate (NMDA)-receptor antagonist indicated for the
treatment of moderate to severe Alzheimer's disease; Benicar(R)
(olmesartan medoxomil), an angiotensin receptor blocker, and Benicar
HCT(R) (olmesartan medoxomil - hydrochlorothiazide), an angiotensin
receptor blocker and diuretic combination product, each indicated for the
treatment of hypertension; and Campral(R) (acamprosate calcium), indicated
in combination with psychosocial support for the maintenance of abstinence
from alcohol in patients with alcohol dependence who are abstinent at
treatment initiation.
Benicar is a registered trademark of Daiichi Sankyo, Inc., and Campral
is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and
launch of new products, and the risk factors listed from time to time in
the Forest Laboratories' SEC reports, including the Company's Annual Report
on Form 10-K for the fiscal year ended March 31, 2007 and quarterly report
on form 10-Q for the period ended June 30, 2007.
References
1. Joos GF, Schelfhout VJ, Kanniess F et al. Bronchodilator effects of
aclidinium bromide, a novel long-acting anticholinergic, in COPD
patients: a phase II study. European Respiratory Society (ERS) Annual
Congress, September 2007. Poster.
2. Schelfhout VJ, Joos GF, Gil EG et al. Bronchodilator/bronchoprotective
effects of aclidinium bromide, a novel long-acting anticholinergic: a
phase I study. European Respiratory Society (ERS) Annual Congress,
September 2007. Poster.
3. Gavalda A, Miralpeix M, Ramos I et al. Aclidinium bromide, a novel
muscarinic receptor antagonist combining long residence at M3 receptors
and rapid plasma clearance. European Respiratory Society (ERS) Annual
Congress, September 2007. Poster.
4. Miralpeix M, Gavalda A, Morcillo E et al. Assessment of the potency and
duration of action of aclidinium bromide in guinea pig isolated trachea
in vitro. European Respiratory Society (ERS) Annual Congress, September
2007. Poster.
5. Global Initiative for Chronic Obstructive Lung Disease. Global strategy
for the diagnosis, management, and prevention of chronic obstructive
pulmonary disease; MCR Vision, Inc.; 2006
6. CDC, cdc/nceh/airpollution/copd/copdfaq.htm, accessed
September 11, 2007.
Forest Laboratories
frx
View drug information on Benicar; Campral.
Lung Function Decline In Smokers Slowed By Higher Physical Activity Level
Moderate to high levels of regular physical activity are associated with lower lung function decline among smokers and help to moderate their risk of developing chronic obstructive pulmonary disease (COPD), according to a large retrospective cohort study.
The research appears in the first issue for March 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
(A cohort study is one in which a group of subjects are followed over time and compared with another group who are not affected by the condition being studied. Cohort studies are generally preferred to case control studies, since they involve far fewer statistical problems and generally produce more reliable answers.)
Judith Garcia-Aymerich, M.D., Ph.D., of the Center for Research in Environmental Epidemiology at the Institut Municipal d'Investigaci?? M??dica in Barcelona, Spain, and four associates assessed the physical activity, smoking history and lung function of 6,790 persons over 11 years. The investigators excluded individuals with COPD at the study's start.
"Prior to our study, the extent to which regular physical activity could reduce the risk of developing COPD was not known, but both epidemiologic and experimental studies indirectly supported this hypothesis," said Dr. Garcia-Aymerich.
COPD is the fourth-leading cause of death in the United States, killing 122,283 Americans in 2003. It results from chronic bronchitis and emphysema, two lung diseases which frequently co-exist and cause obstruction to airflow that interferes with normal breathing. Smoking is the primary cause of COPD.
Over the course of the 11-year study, 928 patients developed COPD. According to the authors, the reduction in COPD among smokers due to moderate to high levels of physical activity was 21 percent of potential new cases.
The investigators attribute this decline in new cases to regular exercise, which suppresses the production of inflammatory markers in the lungs caused by smoking, and reduces the pathogenesis of COPD.
Until now, smokers' only options for slowing lung function decline included stopping smoking and reducing occupational exposure to smoke. Therefore, Dr. Garcia-Aymerich and colleagues believe that their findings could offer smokers an important alternative.
"The interaction between physical activity and smoking should be taken into account when projecting the future burden of this respiratory disease," said Dr. Garcia-Aymerich.
Contact: Judith Garcia-Aymerich, M.D., Ph.D., Center for Research in Environmental Epidemiology (CREAL), Institut Municipal d'Investigaci?? M??dica (IMIM), Doctor Aiguader 88, 08003 Barcelona, Catalonia, Spain
Contact: Suzy Martin
American Thoracic Society
The research appears in the first issue for March 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
(A cohort study is one in which a group of subjects are followed over time and compared with another group who are not affected by the condition being studied. Cohort studies are generally preferred to case control studies, since they involve far fewer statistical problems and generally produce more reliable answers.)
Judith Garcia-Aymerich, M.D., Ph.D., of the Center for Research in Environmental Epidemiology at the Institut Municipal d'Investigaci?? M??dica in Barcelona, Spain, and four associates assessed the physical activity, smoking history and lung function of 6,790 persons over 11 years. The investigators excluded individuals with COPD at the study's start.
"Prior to our study, the extent to which regular physical activity could reduce the risk of developing COPD was not known, but both epidemiologic and experimental studies indirectly supported this hypothesis," said Dr. Garcia-Aymerich.
COPD is the fourth-leading cause of death in the United States, killing 122,283 Americans in 2003. It results from chronic bronchitis and emphysema, two lung diseases which frequently co-exist and cause obstruction to airflow that interferes with normal breathing. Smoking is the primary cause of COPD.
Over the course of the 11-year study, 928 patients developed COPD. According to the authors, the reduction in COPD among smokers due to moderate to high levels of physical activity was 21 percent of potential new cases.
The investigators attribute this decline in new cases to regular exercise, which suppresses the production of inflammatory markers in the lungs caused by smoking, and reduces the pathogenesis of COPD.
Until now, smokers' only options for slowing lung function decline included stopping smoking and reducing occupational exposure to smoke. Therefore, Dr. Garcia-Aymerich and colleagues believe that their findings could offer smokers an important alternative.
"The interaction between physical activity and smoking should be taken into account when projecting the future burden of this respiratory disease," said Dr. Garcia-Aymerich.
Contact: Judith Garcia-Aymerich, M.D., Ph.D., Center for Research in Environmental Epidemiology (CREAL), Institut Municipal d'Investigaci?? M??dica (IMIM), Doctor Aiguader 88, 08003 Barcelona, Catalonia, Spain
Contact: Suzy Martin
American Thoracic Society
News From The August Issue Of Chest
DIABETES MAY AFFECT LUNGS SIMILAR TO SMOKING
A recent study shows that patients with diabetes may have impaired lung function, similar to the impairment found in smokers. Researchers from The Netherlands conducted a literature review of 40 studies describing the pulmonary function data of 3,182 patients with diabetes and 27,080 control subjects. The metaanalysis showed that, in the absence of overt pulmonary disease, diabetes was associated with a modest but statistically significant impairment in lung function in a restrictive pattern. A subanalysis revealed that the association seemed more pronounced in type 2 diabetes compared with type 1 diabetes. Researchers explain that the degree of lung function impairment found in their study closely resembles that of smoking. They further speculate that diabetes may accelerate lung function decline in those with chronic lung conditions, including chronic obstructive pulmonary disease. The study is published in the August issue of Chest, the peer-reviewed journal of the American College of Chest Physicians: Chest 2010; 138(2):393-406
ASTHMA SYMPTOMS MAY IMPROVE AFTER AEROBIC TRAINING
Regular aerobic exercise may help to improve respiratory symptoms and psychological distress in adult patients with asthma. Brazilian researchers evaluated the outcomes of an asthma program in 101 patients with asthma. In the control group, 50 patients received educational programming and underwent breathing exercises; in the aerobic training group, 51 patients underwent additional aerobic training beyond educational programming and breathing exercises. After 3 months, quality of life scores, asthma symptom-free days, and anxiety and depression levels improved only in the aerobic training group. Furthermore, there was a linear relationship between improvement in aerobic capacity and the days without asthma symptoms. Researchers conclude that aerobic training can play an important role in the clinical management of patients with persistent asthma. The study is published in the August issue of Chest, the peer-reviewed journal of the American College of Chest Physicians: Chest 2010; 138(2):331-337.
HOME DIAGNOSIS AND THERAPY OF SLEEP APNEA A VIABLE OPTION
Home-based diagnosis and treatment of obstructive sleep apnea (OSA) may be a viable option for patients who do not have access to a sleep laboratory for testing, shows a new study. Researchers from the University of Saskatchewan, Saskatoon, SK, Canada, compared sleepiness, sleep quality, quality of life, blood pressure, and CPAP adherence in 102 patients randomized to receive either diagnosis and treatment at home or in a sleep laboratory. After 4 weeks of CPAP therapy, there was no significant difference between the two groups in regard to any sleep measures or CPAP compliance. Researchers conclude that select subjects with suspected OSA could be diagnosed and treated at home. This article is published in the August issue of Chest, the peer-reviewed journal of the American College of Chest Physicians: Chest 2010; 138(2):257-263.
A recent study shows that patients with diabetes may have impaired lung function, similar to the impairment found in smokers. Researchers from The Netherlands conducted a literature review of 40 studies describing the pulmonary function data of 3,182 patients with diabetes and 27,080 control subjects. The metaanalysis showed that, in the absence of overt pulmonary disease, diabetes was associated with a modest but statistically significant impairment in lung function in a restrictive pattern. A subanalysis revealed that the association seemed more pronounced in type 2 diabetes compared with type 1 diabetes. Researchers explain that the degree of lung function impairment found in their study closely resembles that of smoking. They further speculate that diabetes may accelerate lung function decline in those with chronic lung conditions, including chronic obstructive pulmonary disease. The study is published in the August issue of Chest, the peer-reviewed journal of the American College of Chest Physicians: Chest 2010; 138(2):393-406
ASTHMA SYMPTOMS MAY IMPROVE AFTER AEROBIC TRAINING
Regular aerobic exercise may help to improve respiratory symptoms and psychological distress in adult patients with asthma. Brazilian researchers evaluated the outcomes of an asthma program in 101 patients with asthma. In the control group, 50 patients received educational programming and underwent breathing exercises; in the aerobic training group, 51 patients underwent additional aerobic training beyond educational programming and breathing exercises. After 3 months, quality of life scores, asthma symptom-free days, and anxiety and depression levels improved only in the aerobic training group. Furthermore, there was a linear relationship between improvement in aerobic capacity and the days without asthma symptoms. Researchers conclude that aerobic training can play an important role in the clinical management of patients with persistent asthma. The study is published in the August issue of Chest, the peer-reviewed journal of the American College of Chest Physicians: Chest 2010; 138(2):331-337.
HOME DIAGNOSIS AND THERAPY OF SLEEP APNEA A VIABLE OPTION
Home-based diagnosis and treatment of obstructive sleep apnea (OSA) may be a viable option for patients who do not have access to a sleep laboratory for testing, shows a new study. Researchers from the University of Saskatchewan, Saskatoon, SK, Canada, compared sleepiness, sleep quality, quality of life, blood pressure, and CPAP adherence in 102 patients randomized to receive either diagnosis and treatment at home or in a sleep laboratory. After 4 weeks of CPAP therapy, there was no significant difference between the two groups in regard to any sleep measures or CPAP compliance. Researchers conclude that select subjects with suspected OSA could be diagnosed and treated at home. This article is published in the August issue of Chest, the peer-reviewed journal of the American College of Chest Physicians: Chest 2010; 138(2):257-263.
Phase III Data Showed Novartis Investigational Bronchodilator QAB149 Significantly Improved Lung Function In COPD Patients
The Novartis investigational bronchodilator QAB149 (indacaterol) met the primary efficacy endpoints of improved lung function compared to placebo at 12 weeks in three pivotal phase III studies in chronic obstructive pulmonary disease (COPD) patients. In secondary endpoints of these studies, QAB149 demonstrated clinically relevant lung function improvements within five minutes of the first dose, lasting for 24 hours in COPD patients.
The QAB149 data, which were presented at the American Thoracic Society (ATS) 2009 International Conference in San Diego, are the first from the Phase III INVOLVE, INHANCE and INLIGHT-1 trials. These were three multinational, multi-center, randomized, double-blind, placebo-controlled studies in over 3,800 patients with moderate-to-severe COPD.
"Current management of COPD focuses on the use of bronchodilators to optimize lung function," said Professor Stephen I. Rennard, Pulmonary and Critical Care Medicine, University of Nebraska Medical Center. "As presented at the ATS meeting, QAB149 is a long-acting beta-agonist bronchodilator given once daily that significantly improved both airflow and clinical outcomes. The ability to provide bronchodilation on a once-daily basis will be an important addition to the current therapeutic armamentarium in COPD."
In the six-month INHANCE trial, QAB149 150?µg and 300?µg doses significantly improved lung function at 12 weeks compared to placebo. Improvements [measured by difference in trough forced expiratory volume in one second (FEV1 )] were observed after one day (110mL and 140mL), at the 12 week primary endpoint (both doses 180mL), and at 26 weeks (160mL and 180mL). Results were statistically significant (p
The QAB149 data, which were presented at the American Thoracic Society (ATS) 2009 International Conference in San Diego, are the first from the Phase III INVOLVE, INHANCE and INLIGHT-1 trials. These were three multinational, multi-center, randomized, double-blind, placebo-controlled studies in over 3,800 patients with moderate-to-severe COPD.
"Current management of COPD focuses on the use of bronchodilators to optimize lung function," said Professor Stephen I. Rennard, Pulmonary and Critical Care Medicine, University of Nebraska Medical Center. "As presented at the ATS meeting, QAB149 is a long-acting beta-agonist bronchodilator given once daily that significantly improved both airflow and clinical outcomes. The ability to provide bronchodilation on a once-daily basis will be an important addition to the current therapeutic armamentarium in COPD."
In the six-month INHANCE trial, QAB149 150?µg and 300?µg doses significantly improved lung function at 12 weeks compared to placebo. Improvements [measured by difference in trough forced expiratory volume in one second (FEV1 )] were observed after one day (110mL and 140mL), at the 12 week primary endpoint (both doses 180mL), and at 26 weeks (160mL and 180mL). Results were statistically significant (p
State Of Colorado Expands Contract With Alere Medical To Include Medicaid Recipients With COPD
Alere Medical, Inc., a leading health management company, announced today that it has been chosen by the State of Colorado to manage its Medicaid recipients with chronic obstructive pulmonary disease (COPD) beginning in October 2007. This is the second expansion of the State of Colorado's contract with Alere Medical, which is also successfully managing the state's Medicaid heart failure and asthma patients.
"We believe that the success we've achieved with Alere's asthma program, combined with the preliminary positive experience in Alere's heart failure program, will result in similar results for our members with COPD," said Christy Hunter, Disease Management Coordinator for the state.
"Alere has been very pleased with the success of its Medicaid heart failure and asthma programs in Colorado," added Timothy J. Moore, MD, MS, executive vice president and chief medical officer for Alere. "We're confident that our COPD program, with its proven results, can improve the health of the state's members with COPD as well."
The Alere COPD program for the state of Colorado includes telephonic interaction with a specialized respiratory registered nurse, mailed educational materials, online education tools, and a toll-free number for members to call with questions or concerns. High-risk members will be eligible to receive a home monitor that will allow them to transmit symptoms to Alere's registered nurses daily. Moderate- and high-risk members will be eligible to participate in ongoing telephonic education sessions with Alere's registered nurses. Alere's registered nurses will provide intervention and send regular progress reports to the member's physician.
About Alere Medical Inc.
Alere Medical Incorporated is a leader in specialized health management services focusing on a patient-centric, programmatic approach to comprehensive personal health support. Alere's integrated care monitoring system identifies and monitors all medium- and high-risk patients, and prioritizes those patients to facilitate efficient workflow. With published outcomes that exceed those of any competitor, Alere Medical's health management programs improve clinical outcomes for patients, and maximize savings for clients.
Alere Medical has received NCQA Patient and Practitioner Full Accreditation of its disease management programs for heart failure, coronary artery disease, diabetes, asthma and COPD. For more information, visit alere.
"We believe that the success we've achieved with Alere's asthma program, combined with the preliminary positive experience in Alere's heart failure program, will result in similar results for our members with COPD," said Christy Hunter, Disease Management Coordinator for the state.
"Alere has been very pleased with the success of its Medicaid heart failure and asthma programs in Colorado," added Timothy J. Moore, MD, MS, executive vice president and chief medical officer for Alere. "We're confident that our COPD program, with its proven results, can improve the health of the state's members with COPD as well."
The Alere COPD program for the state of Colorado includes telephonic interaction with a specialized respiratory registered nurse, mailed educational materials, online education tools, and a toll-free number for members to call with questions or concerns. High-risk members will be eligible to receive a home monitor that will allow them to transmit symptoms to Alere's registered nurses daily. Moderate- and high-risk members will be eligible to participate in ongoing telephonic education sessions with Alere's registered nurses. Alere's registered nurses will provide intervention and send regular progress reports to the member's physician.
About Alere Medical Inc.
Alere Medical Incorporated is a leader in specialized health management services focusing on a patient-centric, programmatic approach to comprehensive personal health support. Alere's integrated care monitoring system identifies and monitors all medium- and high-risk patients, and prioritizes those patients to facilitate efficient workflow. With published outcomes that exceed those of any competitor, Alere Medical's health management programs improve clinical outcomes for patients, and maximize savings for clients.
Alere Medical has received NCQA Patient and Practitioner Full Accreditation of its disease management programs for heart failure, coronary artery disease, diabetes, asthma and COPD. For more information, visit alere.
Education For Health And Other Leading Experts Call For National Strategies ToTackle COPD - An Emerging Epidemic In The Workforce
COPD Uncovered 2010, a new report issued today,
exposes the devastating economic, social and personal impact of COPD in the 40-65 years
age group - the mainstay of the global workforce1,2. These results have led respiratory
experts to call for the implementation of National Strategies to tackle this disease in the
working age population.
Authored by Education for Health and other leading specialists, the report uncovers the true
cost of COPD in the working age population and reveals its significant impact on work and
quality of life. The authors are appealing to policy makers, the medical community and other
stakeholders such as employers to create and implement tactics such as earlier diagnosis
and management, in order to keep people healthy and productive for longer3.
"It's an economic time-bomb" said Monica Fletcher, Chief Executive of Education for Health.
"The key generation driving the economy in most countries are people aged 40-65 years
and in this harsh economic climate, we need to ensure they stay active and productive. With
the incidence of COPD set to rise, with increasing numbers of women being affected than
previously thought, it can only mean that personal and societal cost will also increase."
"COPD is often considered a disease of old men, but there are far more people aged under
65 years with this condition than previously recognised. We are calling for policy makers to
prioritise the early diagnosis and integrated management of COPD in this population".
COPD has wide ranging implications not only for the affected individual, but also for the
wider community. According to the report, in the UK alone, the economic burden of disease
is UK??1.5 billion per annum5 a similar cost to that incurred by European airlines due to the
recent Icelandic ash cloud! This includes not only direct healthcare costs, but factors such as
lost income tax, payment of state benefits and productivity loss due to COPD. These
calculations are based on the current age of retirement, but as many people expect to have
to work beyond their official retirement date6, the economic impact will continue to rise.
COPD is rapidly becoming one of the world's most serious health issues, affecting 210
million people worldwide4, but only half of these people have been diagnosed. COPD can
dramatically impair the productivity of this population. However, it is preventable and
treatable and we encourage those with symptoms such as persistent cough with phlegm,
breathlessness or a wheezy chest to visit their healthcare provider for a lung function test.
Other Key Insights From The Report Include:
- Society Faces A Double Economic Impact From The Growing Copd Crisis - Patients are losing an
average of $1800 per year in lost income due to their COPD, which equates to lifetime
losses of nearly $20,0003. In addition, nearly 1 in 5 of 45-68 year olds are forced to retire
prematurely due to the condition, thereby incurring increased health costs and reducing
personal contribution from taxation3.
- COPD Places A Significant Cost Impact On Healthcare Systems - Individuals of working age are
most often managed within the primary care setting and this places increasing demands
on primary care services7. However, as COPD severity increases, so does the
requirement for patients to be seen in emergency departments or to require
hospitalization. It is these hospitalizations that are responsible for the majority of the
direct costs associated with COPD8.
- People With COPD Feel Unable To Confidently Plan For The Future - The impact of COPD on
people's earning power and overall household income makes them concerned about its
future impact on their lives, and those of their family, and their ability to maintain the
same lifestyle as they had before3.
- Smoking Rates Remain High Regardless Of Disease Severity - Although smoking cessation is
the only known intervention to alter progression and prognosis of COPD, the report
reveals that almost half of patients with mild disease continue to smoke9, and that even
if everyone did stop smoking today, the rates of COPD would still continue to increase
for the next 20 years10. People with COPD need to receive early and appropriate
management including access to pulmonary rehabilitation services along with
appropriate pharmacological intervention in order to keep the disease under control and
avoid exacerbations.
About COPD
COPD is a debilitating, life-threatening and progressive lung disease that interferes with
normal breathing11. Symptoms are often mistakenly attributed to ageing or other
respiratory diseases such as asthma, resulting in COPD being undetected in about 50% of
cases12 and misdiagnosed in about 23%13. A 30% increase in prevalence is expected by the
year 203014. The estimated prevalence of COPD includes approximately 4-13% of adults in
Europe15-19 and approximately 7% of adults in the United States20. While COPD was
previously more common in men, an increase in smoking among women has led to the
disease affecting men and women almost equally4. There is no cure for COPD but it can be
treated.
About COPD Uncovered
COPD Uncovered represents the combined efforts of a multi-disciplinary committee of
international experts, coming together to bring forward some of the most burning issues in
COPD today. Their aim is to highlight the impact of COPD in an understudied and ignored
patient segment between the ages of 40 and 65.
The COPD Uncovered initiative is a compendium of research and analysis undertaken by
experts in respiratory health. COPD Uncovered was first initiated by Education for Health
and Novartis Pharma AG. Novartis Pharma AG is providing financial support for this
initiative, including by commissioning a number of underlying studies. COPD is also
administered by a secretariat from Chandler Chicco Agency (CCA).
The first report from the initiative was published on World COPD Day 200921. It revealed
that more than two billion working hours are lost each week worldwide due to the
condition, and that if left unchecked, COPD could have significant global workforce and
economic implications on patients, families, employers and society as the disease escalates.
The report called for collaborative efforts from all stakeholders to advance our knowledge
of COPD, dispel some of the myths surrounding the condition, and ultimately improve
disease management for patients in this key population.
About the Authors
The COPD Uncovered Report, issued on World COPD Day 2010, is authored by the following
individuals, supported by Novartis with editorial assistance from medical education
specialists from CCA:
- Monica Fletcher, Chief Executive, Education for Health and National Respiratory Training
Center, principle lead for COPD Uncovered
- Dr Marianella Salapatas, President, European Federation of Allergy and Airways Diseases
Patients' Associations
- Professor Thys van derMolen, Department of General Practice, University of Groningen
- John Walsh, President and CEO, COPD Foundation
References
1. US Census Bureau. Current 2009 Population Survey, 2010 annual social and economic
supplement. Available online here. Accessed
October 2010.
2. Office for National Statistics. Annual survey of hours and earnings. Available online here.
Accessed October 2010.
3. Fletcher MJ et al. COPD has significant social and economic impact on a working-age
population of COPD sufferers; an international survey. Abstract and poster presented at
The American Thoracic Society Congress, 18 May 2010
4. World Health Organization. Chronic obstructive pulmonary disease. Available online here. Accessed October 2010.
5. Baldwin M et al A novel method to estimate the economic impact of COPD in patients of
working age. Poster presented at COPD7 International Multidisciplinary Conference, 2
July 2010.
6. MetLife Mature Market Institute. Boomer bookends. Insights into the oldest and
youngest boomers, February 2009. Available online here. Accessed October 2010.
7. Fletcher M et al. Health care utilization in COPD: the burden carried by primary care
practitioners. Primary Care Resp Journal 2010;19(2):A1.
8. Wouters EF. Economic analysis of the Confronting COPD survey: an overview of results.
Respir Med 2003;97(Suppl. C):S3-14.
9. Fletcher MJ et al. How much do COPD patients smoke? A global survey. Abstract and
poster presented at European Respiratory Society Congress, 2010.
10. Mannino DM, Buist AS. Global burden of COPD: risk factors, prevalence, and future
trends. Lancet 2007;370:765-773.
11. Global initiative for chronic obstructive lung disease (GOLD). Global strategy for the
diagnosis, management, and prevention of chronic obstructive lung disease. Updated
2009. Available online here.. Accessed
October 2010.
12. Halbert RJ, et al. Global burden of COPD: systematic review and meta-analysis. Eur
Respir J 2006;28:523-532.
13. T??lamo C, et al. Diagnostic Labeling of COPD in Five Latin American Cities. CHEST
2007;131(1):60-67.
14. Fletcher MJ et al. Patients of working age with COPD have reduced quality of life in
comparison to available population norms; an international survey. Abstract and poster
presented at The American Thoracic Society Congress 18 May 2010
15. Stang P, Lydick E, Silberman C et al. The prevalence of COPD: using smoking rates to
estimate disease frequency in the general population. Chest 2000;117;354S-9S.
16. Buist AS, McBurnie MA, Vollmer WM, Gillespie S, Burney P, Mannino DM, et al.
International variation in the prevalence of COPD (the BOLD Study): a population-based
prevalence study. Lancet 2007;370(9589):741-50.
17. Viegi G, Pedreschi M, Pistelli F et al. Prevalence of Airways Obstruction in a General
Population:European Respiratory Society vs American Thoracic Society Definition. Chest
2000;117:339S-345S.
18. Pe??a VS, Miravitlles M, Gabriel R et al. Geographic variations in prevalence and
underdiagnosis of COPD: results of the IBERPOC multicenter epidemiological study.
Chest 2000;118:981-989.
19. Shahab L, Jarvis M, Britton J, West R. Prevalence, diagnosis and relation to tobacco
dependence of chronic obstructive pulmonary disease in a nationally representative
population sample. Thorax 2006;61:1043-1047.
20. Mannino DM, et al. Obstructive and restrictive lung disease and functional limitation:
data from the Third National Health and Nutrition Examination. Journal of Internal
Medicine 2003;254:540-547.
21. Fletcher M, van der Molen T, Salapatas M,Walsh J. COPD Uncovered: a Report. ISBN: 978-0-
9565537
exposes the devastating economic, social and personal impact of COPD in the 40-65 years
age group - the mainstay of the global workforce1,2. These results have led respiratory
experts to call for the implementation of National Strategies to tackle this disease in the
working age population.
Authored by Education for Health and other leading specialists, the report uncovers the true
cost of COPD in the working age population and reveals its significant impact on work and
quality of life. The authors are appealing to policy makers, the medical community and other
stakeholders such as employers to create and implement tactics such as earlier diagnosis
and management, in order to keep people healthy and productive for longer3.
"It's an economic time-bomb" said Monica Fletcher, Chief Executive of Education for Health.
"The key generation driving the economy in most countries are people aged 40-65 years
and in this harsh economic climate, we need to ensure they stay active and productive. With
the incidence of COPD set to rise, with increasing numbers of women being affected than
previously thought, it can only mean that personal and societal cost will also increase."
"COPD is often considered a disease of old men, but there are far more people aged under
65 years with this condition than previously recognised. We are calling for policy makers to
prioritise the early diagnosis and integrated management of COPD in this population".
COPD has wide ranging implications not only for the affected individual, but also for the
wider community. According to the report, in the UK alone, the economic burden of disease
is UK??1.5 billion per annum5 a similar cost to that incurred by European airlines due to the
recent Icelandic ash cloud! This includes not only direct healthcare costs, but factors such as
lost income tax, payment of state benefits and productivity loss due to COPD. These
calculations are based on the current age of retirement, but as many people expect to have
to work beyond their official retirement date6, the economic impact will continue to rise.
COPD is rapidly becoming one of the world's most serious health issues, affecting 210
million people worldwide4, but only half of these people have been diagnosed. COPD can
dramatically impair the productivity of this population. However, it is preventable and
treatable and we encourage those with symptoms such as persistent cough with phlegm,
breathlessness or a wheezy chest to visit their healthcare provider for a lung function test.
Other Key Insights From The Report Include:
- Society Faces A Double Economic Impact From The Growing Copd Crisis - Patients are losing an
average of $1800 per year in lost income due to their COPD, which equates to lifetime
losses of nearly $20,0003. In addition, nearly 1 in 5 of 45-68 year olds are forced to retire
prematurely due to the condition, thereby incurring increased health costs and reducing
personal contribution from taxation3.
- COPD Places A Significant Cost Impact On Healthcare Systems - Individuals of working age are
most often managed within the primary care setting and this places increasing demands
on primary care services7. However, as COPD severity increases, so does the
requirement for patients to be seen in emergency departments or to require
hospitalization. It is these hospitalizations that are responsible for the majority of the
direct costs associated with COPD8.
- People With COPD Feel Unable To Confidently Plan For The Future - The impact of COPD on
people's earning power and overall household income makes them concerned about its
future impact on their lives, and those of their family, and their ability to maintain the
same lifestyle as they had before3.
- Smoking Rates Remain High Regardless Of Disease Severity - Although smoking cessation is
the only known intervention to alter progression and prognosis of COPD, the report
reveals that almost half of patients with mild disease continue to smoke9, and that even
if everyone did stop smoking today, the rates of COPD would still continue to increase
for the next 20 years10. People with COPD need to receive early and appropriate
management including access to pulmonary rehabilitation services along with
appropriate pharmacological intervention in order to keep the disease under control and
avoid exacerbations.
About COPD
COPD is a debilitating, life-threatening and progressive lung disease that interferes with
normal breathing11. Symptoms are often mistakenly attributed to ageing or other
respiratory diseases such as asthma, resulting in COPD being undetected in about 50% of
cases12 and misdiagnosed in about 23%13. A 30% increase in prevalence is expected by the
year 203014. The estimated prevalence of COPD includes approximately 4-13% of adults in
Europe15-19 and approximately 7% of adults in the United States20. While COPD was
previously more common in men, an increase in smoking among women has led to the
disease affecting men and women almost equally4. There is no cure for COPD but it can be
treated.
About COPD Uncovered
COPD Uncovered represents the combined efforts of a multi-disciplinary committee of
international experts, coming together to bring forward some of the most burning issues in
COPD today. Their aim is to highlight the impact of COPD in an understudied and ignored
patient segment between the ages of 40 and 65.
The COPD Uncovered initiative is a compendium of research and analysis undertaken by
experts in respiratory health. COPD Uncovered was first initiated by Education for Health
and Novartis Pharma AG. Novartis Pharma AG is providing financial support for this
initiative, including by commissioning a number of underlying studies. COPD is also
administered by a secretariat from Chandler Chicco Agency (CCA).
The first report from the initiative was published on World COPD Day 200921. It revealed
that more than two billion working hours are lost each week worldwide due to the
condition, and that if left unchecked, COPD could have significant global workforce and
economic implications on patients, families, employers and society as the disease escalates.
The report called for collaborative efforts from all stakeholders to advance our knowledge
of COPD, dispel some of the myths surrounding the condition, and ultimately improve
disease management for patients in this key population.
About the Authors
The COPD Uncovered Report, issued on World COPD Day 2010, is authored by the following
individuals, supported by Novartis with editorial assistance from medical education
specialists from CCA:
- Monica Fletcher, Chief Executive, Education for Health and National Respiratory Training
Center, principle lead for COPD Uncovered
- Dr Marianella Salapatas, President, European Federation of Allergy and Airways Diseases
Patients' Associations
- Professor Thys van derMolen, Department of General Practice, University of Groningen
- John Walsh, President and CEO, COPD Foundation
References
1. US Census Bureau. Current 2009 Population Survey, 2010 annual social and economic
supplement. Available online here. Accessed
October 2010.
2. Office for National Statistics. Annual survey of hours and earnings. Available online here.
Accessed October 2010.
3. Fletcher MJ et al. COPD has significant social and economic impact on a working-age
population of COPD sufferers; an international survey. Abstract and poster presented at
The American Thoracic Society Congress, 18 May 2010
4. World Health Organization. Chronic obstructive pulmonary disease. Available online here. Accessed October 2010.
5. Baldwin M et al A novel method to estimate the economic impact of COPD in patients of
working age. Poster presented at COPD7 International Multidisciplinary Conference, 2
July 2010.
6. MetLife Mature Market Institute. Boomer bookends. Insights into the oldest and
youngest boomers, February 2009. Available online here. Accessed October 2010.
7. Fletcher M et al. Health care utilization in COPD: the burden carried by primary care
practitioners. Primary Care Resp Journal 2010;19(2):A1.
8. Wouters EF. Economic analysis of the Confronting COPD survey: an overview of results.
Respir Med 2003;97(Suppl. C):S3-14.
9. Fletcher MJ et al. How much do COPD patients smoke? A global survey. Abstract and
poster presented at European Respiratory Society Congress, 2010.
10. Mannino DM, Buist AS. Global burden of COPD: risk factors, prevalence, and future
trends. Lancet 2007;370:765-773.
11. Global initiative for chronic obstructive lung disease (GOLD). Global strategy for the
diagnosis, management, and prevention of chronic obstructive lung disease. Updated
2009. Available online here.. Accessed
October 2010.
12. Halbert RJ, et al. Global burden of COPD: systematic review and meta-analysis. Eur
Respir J 2006;28:523-532.
13. T??lamo C, et al. Diagnostic Labeling of COPD in Five Latin American Cities. CHEST
2007;131(1):60-67.
14. Fletcher MJ et al. Patients of working age with COPD have reduced quality of life in
comparison to available population norms; an international survey. Abstract and poster
presented at The American Thoracic Society Congress 18 May 2010
15. Stang P, Lydick E, Silberman C et al. The prevalence of COPD: using smoking rates to
estimate disease frequency in the general population. Chest 2000;117;354S-9S.
16. Buist AS, McBurnie MA, Vollmer WM, Gillespie S, Burney P, Mannino DM, et al.
International variation in the prevalence of COPD (the BOLD Study): a population-based
prevalence study. Lancet 2007;370(9589):741-50.
17. Viegi G, Pedreschi M, Pistelli F et al. Prevalence of Airways Obstruction in a General
Population:European Respiratory Society vs American Thoracic Society Definition. Chest
2000;117:339S-345S.
18. Pe??a VS, Miravitlles M, Gabriel R et al. Geographic variations in prevalence and
underdiagnosis of COPD: results of the IBERPOC multicenter epidemiological study.
Chest 2000;118:981-989.
19. Shahab L, Jarvis M, Britton J, West R. Prevalence, diagnosis and relation to tobacco
dependence of chronic obstructive pulmonary disease in a nationally representative
population sample. Thorax 2006;61:1043-1047.
20. Mannino DM, et al. Obstructive and restrictive lung disease and functional limitation:
data from the Third National Health and Nutrition Examination. Journal of Internal
Medicine 2003;254:540-547.
21. Fletcher M, van der Molen T, Salapatas M,Walsh J. COPD Uncovered: a Report. ISBN: 978-0-
9565537
Loss of Bone Density with Inhaled Corticosteroids
Study participants with mild to moderate chronic obstructive pulmonary disease (COPD) who used 1,200 micrograms per day
over 3 years of an inhaled corticosteroid, triamcinalon, in an attempt to slow lung function decline showed reduced bone
density in both the lumbar spine and neck of the femur (thigh).
The researchers investigated bone metabolism in COPD in 412 subgroup participants involved in Lung Health Study II. All
subjects, who were either current smokers or recent quitters, underwent bone mineral density scans of the hip and lumbar
spine with dual-energy X-ray absorptiometry at the start of the study, after 1 year, and at the end of year 3. (In COPD,
patients have persistent obstruction of the airways associated with either emphysema or chronic bronchitis, caused by years
of smoking.)
The reductions were 1.78 percent in femoral neck bone mass density and 1.33 percent in lumbar spine bone mass density. The
declines occurred in both the men and women patients who were from 55 to 57 years old. Good adherence to therapy (more than 9
puffs of inhaled corticosteroid per day over 3 years) was seen in almost 47 percent of the patients.
The authors said that there was little or no decline in bone mass density until after the first year of the study, but
reductions did occur during the second and third years of the trial. Since smoking prevalence is high in persons with COPD,
the authors urged doctors to encourage patients to quit. The study appears in the second issue for December 2004 of the
American Thoracic Society's peer-reviewed American Journal of Respiratory and Critical Care Medicine.
American Thoracic Society Journal news tips for December 2004 (second issue)
For the complete text of these articles, please see the American Thoracic Society Online Web Site at atsjournals. For either contact information or to
request a complimentary journalist subscription to ATS journals online, or if you would like to add your name to the
Society's twice monthly journal news e-mail list, contact Cathy Carlomagno at 212-315-6442, or by e-mail at
ccarlomagnothoracic.
Contact: Cathy Carlomagno
ccarlomagnothoracic
212-315-6442
American Thoracic Society
over 3 years of an inhaled corticosteroid, triamcinalon, in an attempt to slow lung function decline showed reduced bone
density in both the lumbar spine and neck of the femur (thigh).
The researchers investigated bone metabolism in COPD in 412 subgroup participants involved in Lung Health Study II. All
subjects, who were either current smokers or recent quitters, underwent bone mineral density scans of the hip and lumbar
spine with dual-energy X-ray absorptiometry at the start of the study, after 1 year, and at the end of year 3. (In COPD,
patients have persistent obstruction of the airways associated with either emphysema or chronic bronchitis, caused by years
of smoking.)
The reductions were 1.78 percent in femoral neck bone mass density and 1.33 percent in lumbar spine bone mass density. The
declines occurred in both the men and women patients who were from 55 to 57 years old. Good adherence to therapy (more than 9
puffs of inhaled corticosteroid per day over 3 years) was seen in almost 47 percent of the patients.
The authors said that there was little or no decline in bone mass density until after the first year of the study, but
reductions did occur during the second and third years of the trial. Since smoking prevalence is high in persons with COPD,
the authors urged doctors to encourage patients to quit. The study appears in the second issue for December 2004 of the
American Thoracic Society's peer-reviewed American Journal of Respiratory and Critical Care Medicine.
American Thoracic Society Journal news tips for December 2004 (second issue)
For the complete text of these articles, please see the American Thoracic Society Online Web Site at atsjournals. For either contact information or to
request a complimentary journalist subscription to ATS journals online, or if you would like to add your name to the
Society's twice monthly journal news e-mail list, contact Cathy Carlomagno at 212-315-6442, or by e-mail at
ccarlomagnothoracic.
Contact: Cathy Carlomagno
ccarlomagnothoracic
212-315-6442
American Thoracic Society
COPD Patients Should Begin Treatment At An Earlier Stage
While the effectiveness of drug therapy for COPD patients at advanced stages of disease has been proven, little evidence exists regarding starting treatment at earlier stages. The findings of the UPLIFT study, published in an Article Online First to coincide with this week's COPD special issue of The Lancet, show that treatment with inhaled tiotropium at an earlier stage of COPD reduces decline of lung function-and thus treatment should begin at this earlier stage. The Article is written by Professor Marc Decramer, University Hospital, University of Leuven, Belgium, and colleagues.
Although the UPLIFT study investigated patients at all stages of the disease, the authors in this paper did a pre-specified subgroup analysis of patients specifically at GOLD stage II* (moderate disease). From a total of 5993 patients, 2739 had GOLD stage II COPD at randomisation, with a mean age of 64 years. Pre-bronchodilator spirometry was done prior to administration of study drug in the morning of a clinic visit (i.e. 24 hours after the last dose of study medication). Post-bronchodilator spirometry was performed after study drug and short-acting bronchodilators (ipratropium and salbutamol). The patients had a mean post-bronchodilator FEV1** volume of 1.63L, 59% of the predicted value. A total of 2376 patients qualified for the final analysis-of these, 1218 patients had received tiotropium and 1158 placebo over a period of four years.
The researchers found that the rate of decline of mean post-bronchodilator FEV1 per year was 12% lower in the tiotropium group than the placebo group (43 mL vs 49 mL). The rate of decline of mean pre-bronchodilator FEV1 did not differ significantly between groups (35 mL v 37 mL per year). Patients given tiotropium were also found to have better health status (measured by questionnaire) at all timepoints. The risk of an exacerbation (serious worsening of symptoms) was reduced by 18% for patients who received tiotropium, and patients receiving tiotropium also saw the risk of a hospital admission due to an exacerbation fall by 26%.
The authors conclude: "In patients with GOLD stage II COPD, long-term treatment with tiotropium seemed to reduce the rate of decline of post-bronchodilator FEV1 and the risk of exacerbations. Since we also found that lung function and health-related quality of life were better in the tiotropium group than in the control group throughout the trial, treatment of COPD should begin in symptomatic patients with moderate disease."
In an accompanying Comment, Dr Lisa Davies, Aintree Chest Centre, University Hospital Aintree, Liverpool, UK and Professor Peter M A Calverley, University of Liverpool, Liverpool, UK, say: "As the UPLIFT investigators comment, there are still substantial numbers of symptomatic patients in GOLD stage II without a clinical diagnosis. Their data should encourage those developing plans for the early identification of COPD, which includes the UK Department of Health, that identifying such patients is indeed worthwhile and can provide the patient with better symptomatic control of their condition and improvements in their overall wellbeing."
Link to article
Source
The Lancet
Although the UPLIFT study investigated patients at all stages of the disease, the authors in this paper did a pre-specified subgroup analysis of patients specifically at GOLD stage II* (moderate disease). From a total of 5993 patients, 2739 had GOLD stage II COPD at randomisation, with a mean age of 64 years. Pre-bronchodilator spirometry was done prior to administration of study drug in the morning of a clinic visit (i.e. 24 hours after the last dose of study medication). Post-bronchodilator spirometry was performed after study drug and short-acting bronchodilators (ipratropium and salbutamol). The patients had a mean post-bronchodilator FEV1** volume of 1.63L, 59% of the predicted value. A total of 2376 patients qualified for the final analysis-of these, 1218 patients had received tiotropium and 1158 placebo over a period of four years.
The researchers found that the rate of decline of mean post-bronchodilator FEV1 per year was 12% lower in the tiotropium group than the placebo group (43 mL vs 49 mL). The rate of decline of mean pre-bronchodilator FEV1 did not differ significantly between groups (35 mL v 37 mL per year). Patients given tiotropium were also found to have better health status (measured by questionnaire) at all timepoints. The risk of an exacerbation (serious worsening of symptoms) was reduced by 18% for patients who received tiotropium, and patients receiving tiotropium also saw the risk of a hospital admission due to an exacerbation fall by 26%.
The authors conclude: "In patients with GOLD stage II COPD, long-term treatment with tiotropium seemed to reduce the rate of decline of post-bronchodilator FEV1 and the risk of exacerbations. Since we also found that lung function and health-related quality of life were better in the tiotropium group than in the control group throughout the trial, treatment of COPD should begin in symptomatic patients with moderate disease."
In an accompanying Comment, Dr Lisa Davies, Aintree Chest Centre, University Hospital Aintree, Liverpool, UK and Professor Peter M A Calverley, University of Liverpool, Liverpool, UK, say: "As the UPLIFT investigators comment, there are still substantial numbers of symptomatic patients in GOLD stage II without a clinical diagnosis. Their data should encourage those developing plans for the early identification of COPD, which includes the UK Department of Health, that identifying such patients is indeed worthwhile and can provide the patient with better symptomatic control of their condition and improvements in their overall wellbeing."
Link to article
Source
The Lancet
Millions of Americans have COPD, some diagnosed, some not
Millions of Americans have already been diagnosed with chronic obstructive pulmonary disease (COPD). Millions more remain undiagnosed and are at serious risk for health complications. Questions, conversation, and education in the clinical setting facilitate early detection and improve outcomes.
Chronic obstructive pulmonary disease (COPD) is a slowly progressive condition of the airways characterized by a gradual loss of lung function. "The National Health and Nutrition Evaluation Survey III (NHANES III) estimated that 16 million people carry a diagnosis of COPD as diagnosed by physicians or healthcare workers, 2.2 million of which have emphysema while the rest have chronic obstructive bronchitis," says Dennis E. Doherty, MD, FCCP. "Some studies have suggested that millions more have the disease. Based on the data from NHANES III, it is estimated that between 45 and 50 million people have the disease, and that as many as two-thirds of those individuals are not yet diagnosed or do not know that they carry the diagnosis."
Dr. Doherty says patient-provider communication issues contribute to COPD underdiagnosis. Fears and misconceptions often make patients reluctant to discuss their symptoms. Physicians may need to seize the communication initiative.
"Over 85% of all COPD is caused by smoking tobacco, but many patients don't want to quit smoking and they won't tell their physician about their habit," he says. "But we need to be asking our patients questions about their habits. We also must remember to check for genetic predispositions. A deficiency of alpha- 1 antitrypsin places people at an increased risk to develop COPD."
Other research has indicated that COPD is misdiagnosed as asthma, especially in women, according to Dr. Doherty.
"Patients may feel less apprehensive about an asthma diagnosis because there isn't a stigma attached to it like COPD. Even though the majority of COPD cases tend to be mild rather than severe, patients still think it is a death sentence. The disease is partially reversible, especially during its earlier stages. Patients may not get back their normal lung function with treatment, but lung function, quality of life, and activities of daily living can improve with proper pharmacologic and non-pharmacologic therapies."
CONTINUES.........Physician's Weekly
Chronic obstructive pulmonary disease (COPD) is a slowly progressive condition of the airways characterized by a gradual loss of lung function. "The National Health and Nutrition Evaluation Survey III (NHANES III) estimated that 16 million people carry a diagnosis of COPD as diagnosed by physicians or healthcare workers, 2.2 million of which have emphysema while the rest have chronic obstructive bronchitis," says Dennis E. Doherty, MD, FCCP. "Some studies have suggested that millions more have the disease. Based on the data from NHANES III, it is estimated that between 45 and 50 million people have the disease, and that as many as two-thirds of those individuals are not yet diagnosed or do not know that they carry the diagnosis."
Dr. Doherty says patient-provider communication issues contribute to COPD underdiagnosis. Fears and misconceptions often make patients reluctant to discuss their symptoms. Physicians may need to seize the communication initiative.
"Over 85% of all COPD is caused by smoking tobacco, but many patients don't want to quit smoking and they won't tell their physician about their habit," he says. "But we need to be asking our patients questions about their habits. We also must remember to check for genetic predispositions. A deficiency of alpha- 1 antitrypsin places people at an increased risk to develop COPD."
Other research has indicated that COPD is misdiagnosed as asthma, especially in women, according to Dr. Doherty.
"Patients may feel less apprehensive about an asthma diagnosis because there isn't a stigma attached to it like COPD. Even though the majority of COPD cases tend to be mild rather than severe, patients still think it is a death sentence. The disease is partially reversible, especially during its earlier stages. Patients may not get back their normal lung function with treatment, but lung function, quality of life, and activities of daily living can improve with proper pharmacologic and non-pharmacologic therapies."
CONTINUES.........Physician's Weekly
HIV Infection Linked To Chronic Lung Disease
New research shows that patients who are HIV positive may be at an increased risk for developing chronic obstructive pulmonary disease (COPD). Researchers from Yale University School of Medicine investigated the prevalence of COPD among 1,014 HIV-positive and 713 HIV-negative men enrolled in the Veterans Aging Cohort 5 Site Study. Results showed that the prevalence of COPD was 10 percent in HIV-positive and 9 percent in HIV-negative patients, as reported by ICD-9 codes, and 15 percent and 12 percent respectively, as indicated by patient self-report. However, after adjusting for age, race/ethnicity, pack-years of smoking, and injection drug use and alcohol abuse, HIV infection was an independent risk factor for COPD, with HIV-infected patients 50 to 60 percent more likely to have COPD than HIV-negative subjects. This study appears in the November issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.
Newsbriefs from the journal Chest, November 2006
Contact: Jennifer Stawarz
American College of Chest Physicians
Newsbriefs from the journal Chest, November 2006
Contact: Jennifer Stawarz
American College of Chest Physicians
Respiratory Function Conditioned By Inflammation Markers And Genetic Profile
There are close links between blood inflammatory markers,
such as C-reactive protein (CRP), and respiratory function.
So reveals a study to be published in the forthcoming issue
of the European Respiratory Journal (ERJ), the peer-reviewed
publication of the European Respiratory Society (ERS).
This original research by an international team provides additional
support for the idea that chronic obstructive pulmonary
disease (COPD) is not limited to the lungs, and is a more systemic
condition.
The results of the ERJ study also suggest that signs of systemic
inflammation may precede a deterioration in respiratory parameters,
which could have implications for the treatment of this type of
pathology.
While local inflammatory phenomena have been widely described in
connection with airway conditions, data on links between systemic
inflammation processes and respiratory parameters are rare.
To clarify such possible interactions, an international team headed
by Jordi Sunyer (Municipal Institute of Medical Research, IMIM,
Barcelona, Spain) undertook this groundbreaking study, which also
takes into account genetic polymorphisms coding for the principal
inflammatory markers. The team worked with colleagues based in Italy,
Germany and Finland.
CRP's key role
For this original study, the researchers selected 134 myocardial
infarction survivors, who were participants in the multicentre
AIRGENE study. The 134 volunteers, recruited an average of 2.7 years
after their last heart attack, were examined six times at four-week
intervals.
Each time they examined the subjects, the researchers carried out a
full set of tests for inflammation, measuring CRP, interleukin-6 and
fibrinogen. They also conducted genotyping of the 36 polymorphisms of
coding genes for these three inflammatory markers. In parallel,
respiratory function was explored using spirometric testing.
As a result, the authors of the ERJ article were able to clearly
observe an inverse correlation between blood levels of CRP and
interleukin-6 on the one hand, and respiratory volume on the other.
When other parameters were taken into account, this correlation was
found to be independent of smoking and factors connected with the
severity of the cardiac condition.
On studying the subjects' genetic profiles, Sunyer also observed that
certain (rare) variants of the CRP gene (polymorphism rs1205 and
haplotype 2) were associated with better respiratory parameters at
spirometric testing.
The study's authors note that these two variants had been linked to a
low CRP level in previous studies. "This suggests that heritability
of lung function, like basal CRP level, is partially controlled by
the CRP gene," they explain.
COPD: a systemic condition?
No link was found, however, between the interleukin-6 gene and
spirometric data. Respiratory function was also found to be
independent of serum levels of fibrinogen and its coding gene
polymorphism.
This research thus provides support for the increasingly popular idea
that COPD, which includes chronic bronchitis and emphysema, amongst
others, is a systemic condition and not only a respiratory disease.
If confirmed, this theory could have major practical consequences for
the treatment of COPD.
The results published in the forthcoming issue of theERJ also
suggest that signs of systemic inflammation could precede a
deterioration of respiratory parameters, which could be a useful
warning signal.
Sunyer remains cautious, however, pointing to the limitations of his
work: the small subject group makes it more difficult to provide
incontrovertible evidence of the role of a genotype variant.
Furthermore, the nature of the population studied (myocardial
infarction survivors) may explain the lack of associations between
respiratory function and fibrinogen, since most of the patients were
taking statins, which are known to reduce fibrinogen levels.
This is a preliminary study, Sunyer emphasises, and needs to be
confirmed by other research before its conclusions can be generalised.
Title Of The Original Article
Systemic inflammation, genetic susceptibility and lung function
The European Respiratory Journal is the peer-reviewed scientific publication
of the European Respiratory Society (more than 8,000 specialists in lung
diseases and respiratory medicine in Europe, the United States and
Australia).
European Respiratory Journal
such as C-reactive protein (CRP), and respiratory function.
So reveals a study to be published in the forthcoming issue
of the European Respiratory Journal (ERJ), the peer-reviewed
publication of the European Respiratory Society (ERS).
This original research by an international team provides additional
support for the idea that chronic obstructive pulmonary
disease (COPD) is not limited to the lungs, and is a more systemic
condition.
The results of the ERJ study also suggest that signs of systemic
inflammation may precede a deterioration in respiratory parameters,
which could have implications for the treatment of this type of
pathology.
While local inflammatory phenomena have been widely described in
connection with airway conditions, data on links between systemic
inflammation processes and respiratory parameters are rare.
To clarify such possible interactions, an international team headed
by Jordi Sunyer (Municipal Institute of Medical Research, IMIM,
Barcelona, Spain) undertook this groundbreaking study, which also
takes into account genetic polymorphisms coding for the principal
inflammatory markers. The team worked with colleagues based in Italy,
Germany and Finland.
CRP's key role
For this original study, the researchers selected 134 myocardial
infarction survivors, who were participants in the multicentre
AIRGENE study. The 134 volunteers, recruited an average of 2.7 years
after their last heart attack, were examined six times at four-week
intervals.
Each time they examined the subjects, the researchers carried out a
full set of tests for inflammation, measuring CRP, interleukin-6 and
fibrinogen. They also conducted genotyping of the 36 polymorphisms of
coding genes for these three inflammatory markers. In parallel,
respiratory function was explored using spirometric testing.
As a result, the authors of the ERJ article were able to clearly
observe an inverse correlation between blood levels of CRP and
interleukin-6 on the one hand, and respiratory volume on the other.
When other parameters were taken into account, this correlation was
found to be independent of smoking and factors connected with the
severity of the cardiac condition.
On studying the subjects' genetic profiles, Sunyer also observed that
certain (rare) variants of the CRP gene (polymorphism rs1205 and
haplotype 2) were associated with better respiratory parameters at
spirometric testing.
The study's authors note that these two variants had been linked to a
low CRP level in previous studies. "This suggests that heritability
of lung function, like basal CRP level, is partially controlled by
the CRP gene," they explain.
COPD: a systemic condition?
No link was found, however, between the interleukin-6 gene and
spirometric data. Respiratory function was also found to be
independent of serum levels of fibrinogen and its coding gene
polymorphism.
This research thus provides support for the increasingly popular idea
that COPD, which includes chronic bronchitis and emphysema, amongst
others, is a systemic condition and not only a respiratory disease.
If confirmed, this theory could have major practical consequences for
the treatment of COPD.
The results published in the forthcoming issue of theERJ also
suggest that signs of systemic inflammation could precede a
deterioration of respiratory parameters, which could be a useful
warning signal.
Sunyer remains cautious, however, pointing to the limitations of his
work: the small subject group makes it more difficult to provide
incontrovertible evidence of the role of a genotype variant.
Furthermore, the nature of the population studied (myocardial
infarction survivors) may explain the lack of associations between
respiratory function and fibrinogen, since most of the patients were
taking statins, which are known to reduce fibrinogen levels.
This is a preliminary study, Sunyer emphasises, and needs to be
confirmed by other research before its conclusions can be generalised.
Title Of The Original Article
Systemic inflammation, genetic susceptibility and lung function
The European Respiratory Journal is the peer-reviewed scientific publication
of the European Respiratory Society (more than 8,000 specialists in lung
diseases and respiratory medicine in Europe, the United States and
Australia).
European Respiratory Journal
Genes appear to play a role in development of chronic obstructive pulmonary disease
USA - A Wake Forest University Baptist Medical Center lung disease specialist reports that some smokers may be genetically predisposed to chronic obstructive pulmonary disease (COPD).
Jill Ohar, professor of pulmonology and critical care medicine at Wake Forest Baptist, presented her findings at the 100th International Conference of the American Thoracic Society in Orlando, Fla., today (May 25).
In her study, Ohar looked at more than 500 men and women age 40 and older who had smoked 20 years or more. She found that a variation of the macrophage scavenger receptor gene (MSR-1) is related to the development of airways obstruction in some patients who smoke cigarettes.
"We found a significant association between sequence variations in the MSR-1 gene and the presence of airways obstruction in smokers that may account for some of the variability in the development of COPD," said Ohar. "This finding may help us to understand why some smokers develop COPD and improve our understanding of how the disease develops."
Smoking is the leading cause of COPD, accounting for 90 percent of all cases. Yet, COPD affects only 15 percent to 20 percent of all smokers.
COPD is a group of lung diseases characterized by limited air flow with variable degrees of enlargement of the lung's air sacs and lung destruction. When diseased, these air sacs, known as alveoli, are unable to completely deflate and are therefore unable to fill with fresh air to ensure adequate oxygen supply to the body. Emphysema and chronic bronchitis are the most common types of COPD.
Ohar was the lead investigator of a team including Arjun B. Chatterjee, M.D., Siquen L. Zheng, M.D., Deborah Meyers, Ph.D., Jing Feng Xu, M.D., and Eugene R. Bleecker, M.D., all from Wake Forest Baptist, and David Sterling, M.D., from the Saint Louis University School of Public Health.
The study was funded in part by the Selikoff Fund for Environmental and Occupational Cancer Research. Irving J. Selikoff. M.D. - the physician and scientist who led the worldwide struggle to prevent exposure to asbestos - created this fund to continue his program of applying the new discoveries in molecular biology for the detection, treatment and prevention of cancer and other diseases associated with the work and community environments.
About Wake Forest University Baptist Medical Center: Wake Forest Baptist is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University School of Medicine. It is licensed to operate 1,282 acute care, psychiatric, rehabilitation and long-term care beds and is consistently ranked as one of "America's Best Hospitals" by U.S. News & World Report.
Contact: Jim Steele
jsteelewfubmc
336-716-4587
Wake Forest University Baptist Medical Center
Jill Ohar, professor of pulmonology and critical care medicine at Wake Forest Baptist, presented her findings at the 100th International Conference of the American Thoracic Society in Orlando, Fla., today (May 25).
In her study, Ohar looked at more than 500 men and women age 40 and older who had smoked 20 years or more. She found that a variation of the macrophage scavenger receptor gene (MSR-1) is related to the development of airways obstruction in some patients who smoke cigarettes.
"We found a significant association between sequence variations in the MSR-1 gene and the presence of airways obstruction in smokers that may account for some of the variability in the development of COPD," said Ohar. "This finding may help us to understand why some smokers develop COPD and improve our understanding of how the disease develops."
Smoking is the leading cause of COPD, accounting for 90 percent of all cases. Yet, COPD affects only 15 percent to 20 percent of all smokers.
COPD is a group of lung diseases characterized by limited air flow with variable degrees of enlargement of the lung's air sacs and lung destruction. When diseased, these air sacs, known as alveoli, are unable to completely deflate and are therefore unable to fill with fresh air to ensure adequate oxygen supply to the body. Emphysema and chronic bronchitis are the most common types of COPD.
Ohar was the lead investigator of a team including Arjun B. Chatterjee, M.D., Siquen L. Zheng, M.D., Deborah Meyers, Ph.D., Jing Feng Xu, M.D., and Eugene R. Bleecker, M.D., all from Wake Forest Baptist, and David Sterling, M.D., from the Saint Louis University School of Public Health.
The study was funded in part by the Selikoff Fund for Environmental and Occupational Cancer Research. Irving J. Selikoff. M.D. - the physician and scientist who led the worldwide struggle to prevent exposure to asbestos - created this fund to continue his program of applying the new discoveries in molecular biology for the detection, treatment and prevention of cancer and other diseases associated with the work and community environments.
About Wake Forest University Baptist Medical Center: Wake Forest Baptist is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University School of Medicine. It is licensed to operate 1,282 acute care, psychiatric, rehabilitation and long-term care beds and is consistently ranked as one of "America's Best Hospitals" by U.S. News & World Report.
Contact: Jim Steele
jsteelewfubmc
336-716-4587
Wake Forest University Baptist Medical Center
Helium Helps Lung Patients Breathe Easier
New research published in the international journal Chest, by Neil Eves, PhD, finds that people with chronic obstructive pulmonary disease (COPD) who breathed a mix of 60% helium and 40% oxygen during a rehabilitation program were able to exercise longer and harder than those who breathed normal air.
This innovative therapy is significant because research has shown that patients who perform more exercise and get greater improvements in fitness also get better improvements in their symptoms and health-related quality of life.
"COPD is not curable," says Eves, a researcher with the Faculties of Kinesiology and Medicine. "Our hope is that this research will help more individuals with COPD to realize the benefits of exercise."
Eves says he chose this specific gas mixture, because helium is a less dense gas that allows patients suffering with COPD to empty their damaged lungs better, while oxygen slows their breathing and further helps to reduce the shortness of breath these patients commonly suffer from. Standard air is generally made up of 78% Nitrogen and 21% Oxygen with just a trace of Helium.
In the study, individuals with COPD breathed either the helium/oxygen mix or air during cycling exercise. While both groups improved their tolerance for exercise over a six-week rehabilitation program, the group that trained with helium could exercise significantly longer following rehabilitation than the control group.
Chronic obstructive pulmonary disease is the fourth leading cause of death in Canada. It currently kills more women than breast cancer and health experts project that the disease will become more prevalent as the population ages.
Interestingly, Eves' innovative research protocol is already being used in a clinical application by Alberta Health Services Chronic Disease Management Program.
"We are always interested in innovations that can help to improve the effectiveness of our health interventions," says Dr. Sandra Delon, PhD, the director of Alberta Health Services' Chronic Disease Management Program. "We've already seen some promising results in this pilot program, so we're very encouraged."
This innovative therapy is significant because research has shown that patients who perform more exercise and get greater improvements in fitness also get better improvements in their symptoms and health-related quality of life.
"COPD is not curable," says Eves, a researcher with the Faculties of Kinesiology and Medicine. "Our hope is that this research will help more individuals with COPD to realize the benefits of exercise."
Eves says he chose this specific gas mixture, because helium is a less dense gas that allows patients suffering with COPD to empty their damaged lungs better, while oxygen slows their breathing and further helps to reduce the shortness of breath these patients commonly suffer from. Standard air is generally made up of 78% Nitrogen and 21% Oxygen with just a trace of Helium.
In the study, individuals with COPD breathed either the helium/oxygen mix or air during cycling exercise. While both groups improved their tolerance for exercise over a six-week rehabilitation program, the group that trained with helium could exercise significantly longer following rehabilitation than the control group.
Chronic obstructive pulmonary disease is the fourth leading cause of death in Canada. It currently kills more women than breast cancer and health experts project that the disease will become more prevalent as the population ages.
Interestingly, Eves' innovative research protocol is already being used in a clinical application by Alberta Health Services Chronic Disease Management Program.
"We are always interested in innovations that can help to improve the effectiveness of our health interventions," says Dr. Sandra Delon, PhD, the director of Alberta Health Services' Chronic Disease Management Program. "We've already seen some promising results in this pilot program, so we're very encouraged."
Testing For COPD Inadequate, Study Finds
Spirometry testing is a widely accepted and encouraged diagnostic method for chronic obstructive pulmonary disease (COPD), but new research shows that it is not used nearly enough. The study appears in the August issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians (ACCP) and reports that only one-third of patients with a COPD diagnosis ever received spirometry testing.
"Without proper testing, both underdiagnosis and misdiagnosis may occur, which can lead to improper therapies being prescribed," said lead author MeiLan Han, MD, MS, University of Michigan, Division of Pulmonary and Critical Care Medicine. "This study shows that we have a lot of work ahead of us in terms of raising awareness among both patients and physicians."
Along with colleagues from Johns Hopkins University, the University of Washington, and the National Committee for Quality Assurance, Dr. Han identified patients with newly diagnosed COPD by data collected from five health plans. The study examined patients aged 40 years and older, and determined if patients with a new diagnosis of COPD had received spirometry in the preceeding 720 days. Of the 5,039 eligible patients identified, only 32% were found to have received spirometry testing. Furthermore, only half of those patients received follow-up bronchodilator testing to confirm their diagnosis.
"In order to distinguish COPD from other diseases, such as asthma, spirometry must be measured both before and after administration of medication that dilates the airways," Dr. Han explained. "As such, if COPD is suspected, initial spirometric testing should include bronchodilator testing too, in order for that patient to receive a truly diagnostic test."
In addition, the study notes that these numbers contradict previous findings in which over 70% of physicians reported using spirometry for establishing a COPD diagnosis. Given the contrast, Dr. Han suggests a possible difference between what physicians say and what they actually do. Also of particular concern was that, according to this study, spirometry testing in those patients who were 75 years and older was performed less frequently, with only 28% of patients in this population receiving spirometry. Researchers point to the issue of ageism and question whether or not a patient's age influences a physician's decision to order diagnostic testing.
"The bad news is that we have significant room for improvement. The good news is that we have to know a problem exists before we can fix it, and now we know," said Dr. Han. Other good news is that women and men fared virtually the same when it came to spirometry testing, despite previous reports suggesting women were tested less often.
"COPD is currently the fourth leading cause of death in the United States, and the economic burden of this disease is measured in the billions of dollars but, despite this, it is so often underdiagnosed or misclassified," said Dr. Han. "Prior to this study, I did not truly appreciate the magnitude of spirometry underutilization, but my hope is that this study will lead to more correct diagnoses and better care of patients."
"Spirometry testing is an inexpensive, quick, and painless procedure, which is necessary to confirm a COPD diagnosis," said Mark J. Rosen, MD, FCCP, President of the American College of Chest Physicians. "In order to make a shift in the underutilization of spirometry, physicians need to use all of the resources available to them, and patients need to actively inquire about their care."
The National Lung Health Education Program suggests that current and former smokers aged 45 years and older, as well as any patient who experiences cough, shortness of breath with exertion, or wheezing, ask their doctor about having a spirometry test performed.
CHEST is a peer-reviewed journal published by the ACCP. It is available online each month at chestjournal. The journal's Web site also provides public access to thousands of archived studies, dating back to 1946 -- a newly added feature that is free of charge. The ACCP represents 16,600 members who provide clinical respiratory care, sleep medicine, critical care, and cardiothoracic patient care in the United States and throughout the world. The ACCP's mission is to promote the prevention and treatment of diseases of the chest through leadership, education, research, and communication. For more information about the ACCP, please visit the ACCP Web site at chestnet/.
"Without proper testing, both underdiagnosis and misdiagnosis may occur, which can lead to improper therapies being prescribed," said lead author MeiLan Han, MD, MS, University of Michigan, Division of Pulmonary and Critical Care Medicine. "This study shows that we have a lot of work ahead of us in terms of raising awareness among both patients and physicians."
Along with colleagues from Johns Hopkins University, the University of Washington, and the National Committee for Quality Assurance, Dr. Han identified patients with newly diagnosed COPD by data collected from five health plans. The study examined patients aged 40 years and older, and determined if patients with a new diagnosis of COPD had received spirometry in the preceeding 720 days. Of the 5,039 eligible patients identified, only 32% were found to have received spirometry testing. Furthermore, only half of those patients received follow-up bronchodilator testing to confirm their diagnosis.
"In order to distinguish COPD from other diseases, such as asthma, spirometry must be measured both before and after administration of medication that dilates the airways," Dr. Han explained. "As such, if COPD is suspected, initial spirometric testing should include bronchodilator testing too, in order for that patient to receive a truly diagnostic test."
In addition, the study notes that these numbers contradict previous findings in which over 70% of physicians reported using spirometry for establishing a COPD diagnosis. Given the contrast, Dr. Han suggests a possible difference between what physicians say and what they actually do. Also of particular concern was that, according to this study, spirometry testing in those patients who were 75 years and older was performed less frequently, with only 28% of patients in this population receiving spirometry. Researchers point to the issue of ageism and question whether or not a patient's age influences a physician's decision to order diagnostic testing.
"The bad news is that we have significant room for improvement. The good news is that we have to know a problem exists before we can fix it, and now we know," said Dr. Han. Other good news is that women and men fared virtually the same when it came to spirometry testing, despite previous reports suggesting women were tested less often.
"COPD is currently the fourth leading cause of death in the United States, and the economic burden of this disease is measured in the billions of dollars but, despite this, it is so often underdiagnosed or misclassified," said Dr. Han. "Prior to this study, I did not truly appreciate the magnitude of spirometry underutilization, but my hope is that this study will lead to more correct diagnoses and better care of patients."
"Spirometry testing is an inexpensive, quick, and painless procedure, which is necessary to confirm a COPD diagnosis," said Mark J. Rosen, MD, FCCP, President of the American College of Chest Physicians. "In order to make a shift in the underutilization of spirometry, physicians need to use all of the resources available to them, and patients need to actively inquire about their care."
The National Lung Health Education Program suggests that current and former smokers aged 45 years and older, as well as any patient who experiences cough, shortness of breath with exertion, or wheezing, ask their doctor about having a spirometry test performed.
CHEST is a peer-reviewed journal published by the ACCP. It is available online each month at chestjournal. The journal's Web site also provides public access to thousands of archived studies, dating back to 1946 -- a newly added feature that is free of charge. The ACCP represents 16,600 members who provide clinical respiratory care, sleep medicine, critical care, and cardiothoracic patient care in the United States and throughout the world. The ACCP's mission is to promote the prevention and treatment of diseases of the chest through leadership, education, research, and communication. For more information about the ACCP, please visit the ACCP Web site at chestnet/.
Possible Alternate Therapy For Adults With Poorly Controlled Asthma
A drug commonly used for the treatment of chronic obstructive pulmonary disease (COPD) successfully treats adults whose asthma is not well-controlled on low doses of inhaled corticosteroids, reported researchers supported by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health.
"This study's results show that tiotropium bromide might provide an alternative to other asthma treatments, expanding options available to patients for controlling their asthma," said NHLBI Acting Director Susan B. Shurin, M.D. "The goal in managing asthma is to prevent symptoms so patients can pursue activities to the fullest."
According to the study, adding tiotropium bromide to low doses of inhaled corticosteroids is more effective at controlling asthma than doubling inhaled corticosteroids alone, and as effective as adding the long-acting beta agonist salmeterol. The results were published online today in the New England Journal of Medicine and presented at the Annual Congress of the European Respiratory Society in Barcelona, Spain.
Increasing inhaled corticosteroids or supplementing them with long-acting beta agonists like salmeterol are the two preferred treatment options available for adults whose asthma is poorly controlled on low doses of inhaled corticosteroids. However, higher doses of corticosteroids do not improve symptoms for all patients and can have significant side effects, while long-acting beta agonists have come under scrutiny for their risk of worsening asthma symptoms that could result in hospitalization and, rarely, death.
"Tiotropium relaxes smooth muscle in the airways through a different mechanism than beta agonists, and thus may help people who do not respond well to currently recommended treatments," said study lead Stephen Peters, M.D., Ph.D., of Wake Forest University Baptist Medical Center, Winston-Salem, N.C. "Further analysis of the study data will help us better understand which patients respond best to tiotropium. Then we will need to conduct longer-term studies to establish its safety for asthma patients and to determine its effect on the frequency and severity of asthma exacerbations."
Conducted by the NHLBI's Asthma Clinical Research Network, the study compared three treatment methods: doubling the dose of inhaled corticosteroids alone, supplementing a low dose of inhaled corticosteroids with a long-acting beta agonist (salmeterol), and supplementing a low dose of inhaled corticosteroids with a long-acting anticholinergic drug (tiotropium bromide). Anticholinergics block a part of the autonomic nervous system that can cause airway muscles to contract. The study followed 210 adults whose asthma was not well-controlled on low doses of inhaled corticosteroids alone. Participants received each treatment for 14 weeks with two-week breaks in between, for a total of 48 weeks.
Tiotropium bromide was shown to be effective using several asthma control measurements, including patients' day-to-day lung function as well as the number of days in which they had no asthma symptoms and did not need to use their albuterol rescue inhalers. When patients began the trial, their average number of such "asthma control days" was 77 per year (extrapolated from the treatment period). Doubling corticosteroids gave patients another 19 symptom-free days on average, while adding tiotropium to low-dose corticosteroids gave them another 48.
"Much research over the last century has explored the role of cholinergic mechanisms [which constrict the airways] and anticholinergic therapies in asthma. However, this is the first study to explore adding an anticholinergic inhaler to low-dose inhaled corticosteroids," said James Kiley, Ph.D., director of the NHLBI's Division of Lung Diseases. "The Asthma Clinical Research Network is designed to address exactly these kinds of practical and important management questions, with the ultimate goal of helping asthma patients."
More information about the trial - Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid, or TALC (NCT00565266) - can be found at clinicaltrials.
Resources:
Asthma clinical practice guidelines
Asthma Clinical Research Network (ACRN)
"This study's results show that tiotropium bromide might provide an alternative to other asthma treatments, expanding options available to patients for controlling their asthma," said NHLBI Acting Director Susan B. Shurin, M.D. "The goal in managing asthma is to prevent symptoms so patients can pursue activities to the fullest."
According to the study, adding tiotropium bromide to low doses of inhaled corticosteroids is more effective at controlling asthma than doubling inhaled corticosteroids alone, and as effective as adding the long-acting beta agonist salmeterol. The results were published online today in the New England Journal of Medicine and presented at the Annual Congress of the European Respiratory Society in Barcelona, Spain.
Increasing inhaled corticosteroids or supplementing them with long-acting beta agonists like salmeterol are the two preferred treatment options available for adults whose asthma is poorly controlled on low doses of inhaled corticosteroids. However, higher doses of corticosteroids do not improve symptoms for all patients and can have significant side effects, while long-acting beta agonists have come under scrutiny for their risk of worsening asthma symptoms that could result in hospitalization and, rarely, death.
"Tiotropium relaxes smooth muscle in the airways through a different mechanism than beta agonists, and thus may help people who do not respond well to currently recommended treatments," said study lead Stephen Peters, M.D., Ph.D., of Wake Forest University Baptist Medical Center, Winston-Salem, N.C. "Further analysis of the study data will help us better understand which patients respond best to tiotropium. Then we will need to conduct longer-term studies to establish its safety for asthma patients and to determine its effect on the frequency and severity of asthma exacerbations."
Conducted by the NHLBI's Asthma Clinical Research Network, the study compared three treatment methods: doubling the dose of inhaled corticosteroids alone, supplementing a low dose of inhaled corticosteroids with a long-acting beta agonist (salmeterol), and supplementing a low dose of inhaled corticosteroids with a long-acting anticholinergic drug (tiotropium bromide). Anticholinergics block a part of the autonomic nervous system that can cause airway muscles to contract. The study followed 210 adults whose asthma was not well-controlled on low doses of inhaled corticosteroids alone. Participants received each treatment for 14 weeks with two-week breaks in between, for a total of 48 weeks.
Tiotropium bromide was shown to be effective using several asthma control measurements, including patients' day-to-day lung function as well as the number of days in which they had no asthma symptoms and did not need to use their albuterol rescue inhalers. When patients began the trial, their average number of such "asthma control days" was 77 per year (extrapolated from the treatment period). Doubling corticosteroids gave patients another 19 symptom-free days on average, while adding tiotropium to low-dose corticosteroids gave them another 48.
"Much research over the last century has explored the role of cholinergic mechanisms [which constrict the airways] and anticholinergic therapies in asthma. However, this is the first study to explore adding an anticholinergic inhaler to low-dose inhaled corticosteroids," said James Kiley, Ph.D., director of the NHLBI's Division of Lung Diseases. "The Asthma Clinical Research Network is designed to address exactly these kinds of practical and important management questions, with the ultimate goal of helping asthma patients."
More information about the trial - Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid, or TALC (NCT00565266) - can be found at clinicaltrials.
Resources:
Asthma clinical practice guidelines
Asthma Clinical Research Network (ACRN)
NICE Consults On New Chronic Obstructive Pulmonary Disease And Chronic Kidney Disease Draft Quality Standards
NICE has today (30 September) launched a consultation on its draft quality standards for chronic obstructive pulmonary disease (COPD)[1] and chronic kidney disease (CKD)[2] in adults. The consultation period will also include field testing during which NICE implementation consultants will visit service providers, GPs and Primary Care Trusts to explore how the standards can be effectively and successfully put into practice.
NICE quality standards reflect the very best in high quality patient care. They aim to help healthcare practitioners and commissioners of care deliver excellent services. They are the only standards in health and social care that apply nationally in England, and are derived from the best available evidence, usually NICE guidance or other sources that have been accredited by NHS Evidence[3].
NICE quality standards are aimed at:
- Patients and the public
- clinicians
- public health practitioners
- commissioners
- service providers.
The draft quality standard on COPD identifies a number of elements of high quality patient care, including:
- People receiving a clinical diagnosis of COPD have a record of one or more indicative symptoms.
- People with COPD who smoke are encouraged to stop and offered help to do so.
- People with COPD, meeting appropriate criteria, are offered an effective pulmonary rehabilitation programme.
The draft quality standard on CKD defines high quality patient care to include the following:
- People with CKD are assessed for disease progression and associated complications.
- People with CKD in defined at risk groups are referred for specialist assessment in accordance with NICE guidance.
- People with CKD are immunised against infection in accordance with current policy.
The draft quality standards are available on the NICE website until 5.00pm, Wednesday 10 November 2010, and allow stakeholders to comment on the drafts and help prioritise which statements are most important to support quality improvement.
Dr Fergus Macbeth, Centre for Clinical Practice Director at NICE said: "The draft NICE quality standards on COPD and CKD have been developed from a range of evidence sources such as published NICE guidance, and the UK Renal Association Clinical Practice Guidelines. The standards will set the benchmark for healthcare quality in these two disease areas, to enable healthcare commissioners and providers to deliver the best care locally. I would encourage all those with an interest in these areas to submit their comments via the NICE website."
These drafts have been issued for consultation;NICE has not yet published the final quality standards to the NHS.
The draft standards are available for consultation on the NICE website until 5.00pm on Wednesday 10 November here.
All eligible comments will be reviewed by the independent Topic Expert Group and the Programme Board and the standards will be refined in light of this information. The final quality standards for COPD and CKD are expected to be published in March 2010.
Notes
--The draft quality standards on COPD are derived from the following evidence sources:
- NICE (2010) Chronic obstructive pulmonary disease: management of chronic obstructive pulmonary disease in adults in primary and secondary care (partial update). NICE clinical guideline 101.
- Department of Health (2010) Consultation on a strategy for services for COPD in England.
--The UK Renal Association Clinical Practice Guidelines can be found here.
--The draft quality standards on CKD in adults are derived from the following evidence sources:
- NICE (2008) Chronic kidney disease: early identification and management of chronic kidney disease in adults in primary and secondary care. NICE clinical guideline 73.
- NICE (2006) Anaemia management in people with chronic kidney disease. NICE clinical guideline 39.
- UK Renal Association (2010) Clinical practice guidelines: Vascular access for haemodialysis.
- UK Renal Association (2010) Clinical practice guidelines: Peritoneal dialysis.
- UK Renal Association (2009) Clinical practice guidelines: Planning, initiating and withdrawal of renal replacement therapy.
- UK Renal Association (2009) Clinical practice guidelines: Peritoneal access.
- UK Renal Association (2009) Clinical practice guidelines: Blood borne virus infection.
- UK Renal Association (2009) Clinical practice guidelines: Haemodialysis.
- UK Renal Association (2008) Clinical practice guidelines: Assessment for renal transplantation.
- UK Renal Association (2008) Clinical practice guidelines: Acute kidney injury.
- Department of Health (2010) Immunisation against infectious disease - 'The Green Book'.
- Department of Health (2009) Achieving excellence in kidney care: Delivering the National Service Framework for Renal Services.
- Department of Health (2007) Second Progress Report on the Renal NSF.
-Department of Health (2004) National Service Framework for Renal Services: Part One - Dialysis and transplantation.
-Department of Health (2005) National Service Framework for Renal Services - Part Two: Chronic kidney disease, acute renal failure and end of life care.
- Transparency in outcomes - a framework for the NHS consultation can be found here.
[1] Chronic obstructive pulmonary disease (COPD) is the name for a collection of lung diseases including chronic bronchitis, emphysema and chronic obstructive airways disease.
[2] Chronic kidney disease (CKD) is a chronic (long-term) condition where the kidneys progressively lose their function.
[3] The recently announced Transparency in Outcomes framework for the NHS proposes using quality standards to produce more detailed commissioning guidance to meet the suggested outcome goals.
NICE quality standards reflect the very best in high quality patient care. They aim to help healthcare practitioners and commissioners of care deliver excellent services. They are the only standards in health and social care that apply nationally in England, and are derived from the best available evidence, usually NICE guidance or other sources that have been accredited by NHS Evidence[3].
NICE quality standards are aimed at:
- Patients and the public
- clinicians
- public health practitioners
- commissioners
- service providers.
The draft quality standard on COPD identifies a number of elements of high quality patient care, including:
- People receiving a clinical diagnosis of COPD have a record of one or more indicative symptoms.
- People with COPD who smoke are encouraged to stop and offered help to do so.
- People with COPD, meeting appropriate criteria, are offered an effective pulmonary rehabilitation programme.
The draft quality standard on CKD defines high quality patient care to include the following:
- People with CKD are assessed for disease progression and associated complications.
- People with CKD in defined at risk groups are referred for specialist assessment in accordance with NICE guidance.
- People with CKD are immunised against infection in accordance with current policy.
The draft quality standards are available on the NICE website until 5.00pm, Wednesday 10 November 2010, and allow stakeholders to comment on the drafts and help prioritise which statements are most important to support quality improvement.
Dr Fergus Macbeth, Centre for Clinical Practice Director at NICE said: "The draft NICE quality standards on COPD and CKD have been developed from a range of evidence sources such as published NICE guidance, and the UK Renal Association Clinical Practice Guidelines. The standards will set the benchmark for healthcare quality in these two disease areas, to enable healthcare commissioners and providers to deliver the best care locally. I would encourage all those with an interest in these areas to submit their comments via the NICE website."
These drafts have been issued for consultation;NICE has not yet published the final quality standards to the NHS.
The draft standards are available for consultation on the NICE website until 5.00pm on Wednesday 10 November here.
All eligible comments will be reviewed by the independent Topic Expert Group and the Programme Board and the standards will be refined in light of this information. The final quality standards for COPD and CKD are expected to be published in March 2010.
Notes
--The draft quality standards on COPD are derived from the following evidence sources:
- NICE (2010) Chronic obstructive pulmonary disease: management of chronic obstructive pulmonary disease in adults in primary and secondary care (partial update). NICE clinical guideline 101.
- Department of Health (2010) Consultation on a strategy for services for COPD in England.
--The UK Renal Association Clinical Practice Guidelines can be found here.
--The draft quality standards on CKD in adults are derived from the following evidence sources:
- NICE (2008) Chronic kidney disease: early identification and management of chronic kidney disease in adults in primary and secondary care. NICE clinical guideline 73.
- NICE (2006) Anaemia management in people with chronic kidney disease. NICE clinical guideline 39.
- UK Renal Association (2010) Clinical practice guidelines: Vascular access for haemodialysis.
- UK Renal Association (2010) Clinical practice guidelines: Peritoneal dialysis.
- UK Renal Association (2009) Clinical practice guidelines: Planning, initiating and withdrawal of renal replacement therapy.
- UK Renal Association (2009) Clinical practice guidelines: Peritoneal access.
- UK Renal Association (2009) Clinical practice guidelines: Blood borne virus infection.
- UK Renal Association (2009) Clinical practice guidelines: Haemodialysis.
- UK Renal Association (2008) Clinical practice guidelines: Assessment for renal transplantation.
- UK Renal Association (2008) Clinical practice guidelines: Acute kidney injury.
- Department of Health (2010) Immunisation against infectious disease - 'The Green Book'.
- Department of Health (2009) Achieving excellence in kidney care: Delivering the National Service Framework for Renal Services.
- Department of Health (2007) Second Progress Report on the Renal NSF.
-Department of Health (2004) National Service Framework for Renal Services: Part One - Dialysis and transplantation.
-Department of Health (2005) National Service Framework for Renal Services - Part Two: Chronic kidney disease, acute renal failure and end of life care.
- Transparency in outcomes - a framework for the NHS consultation can be found here.
[1] Chronic obstructive pulmonary disease (COPD) is the name for a collection of lung diseases including chronic bronchitis, emphysema and chronic obstructive airways disease.
[2] Chronic kidney disease (CKD) is a chronic (long-term) condition where the kidneys progressively lose their function.
[3] The recently announced Transparency in Outcomes framework for the NHS proposes using quality standards to produce more detailed commissioning guidance to meet the suggested outcome goals.
Almirall Strengthens Its Respiratory Franchise With A New Generation Of Chronic Obstructive Pulmonary Disease (COPD) Treatment
Almirall strengthens its position in the respiratory field with a positive development progress of another New Chemical Entity (NCE). LAS190792 is a new dual long-acting Muscarinic Antagonist ??2 Agonist (MABA), which combines two bronchodilator mechanisms in a single molecule for the treatment of COPD. This new class of inhaled long-acting bronchodilators is expected to provide additional symptom relief in patients living with COPD, and to form the basis of so called triple combinations together with ICS (inhaled corticosteroids). The MABA franchise (MABA and MABA/ICS combination) offer the convenience of different mechanisms of action in one inhaler therapy, and is envisaged to become a future block buster in COPD.
"Almirall's MABA (LAS190792) represents an exciting opportunity for the treatment of COPD and shows the strength of Almirall??s commitment to research in respiratory disease", said Dr Bertil Lindmark, MD, PhD, and Chief Scientific Officer at Almirall.
MABA compounds offer the advantage over the two-molecule bronchodilator combinations (LABA/LAMA), in that MABA/ICS combinations can be developed with a reasonable size development programme.
In preclinical models, LAS190792 has shown to have a long duration of action and high anti-muscarinic activity combined with ??2 agonism. The molecule shows very favourable drug properties and safety.
Almirall is planning to prioritize the finalization of the pre-clinical phase, aiming at starting clinical studies during first half of 2012.
LAS190792 will be developed in the Genuair® inhaler, a novel, state-of-the-art, multi-dose dry powder inhaler. It incorporates significant safety features, including one hand dosing, visible dose indicator, an anti-double dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler, as well as audio feedback to confirm successful dose intake. Genuair® is a registered trademark owned by Almirall, S.A.
After aclidinium bromide (monotherapy planned to be filed in mid 2011) and LAS100977 (LABA) + ICS (currently in phase II), this MABA is the third NCE developed by Almirall which will utilize the Genuair® inhaler system.
About COPD
The World Health Organisation (WHO) has described COPD as a global epidemic; an estimated 210 million people have COPD worldwide and more than 3 million people died of the condition in 2005, which is equal to 5% of all deaths globally that year. Total deaths from COPD are projected to increase by more than 30% in the next 10 years without interventions to cut risks, particularly exposure to tobacco smoke.
In patients with COPD the airways in the lungs typically lose their elasticity, produce excess mucus and become thick and inflamed, limiting the passage of air. The most common symptoms of COPD are breathlessness (or a "need for air"), abnormal sputum (a mix of saliva and mucus in the airway), and a chronic cough. Daily activities, such as walking up a short flight of stairs or carrying a suitcase, can become very difficult as the condition gradually worsens. There are significant unmet needs in the treatment of COPD including limited therapeutic options to improve lung function, reduce symptoms and control exacerbations.
"Almirall's MABA (LAS190792) represents an exciting opportunity for the treatment of COPD and shows the strength of Almirall??s commitment to research in respiratory disease", said Dr Bertil Lindmark, MD, PhD, and Chief Scientific Officer at Almirall.
MABA compounds offer the advantage over the two-molecule bronchodilator combinations (LABA/LAMA), in that MABA/ICS combinations can be developed with a reasonable size development programme.
In preclinical models, LAS190792 has shown to have a long duration of action and high anti-muscarinic activity combined with ??2 agonism. The molecule shows very favourable drug properties and safety.
Almirall is planning to prioritize the finalization of the pre-clinical phase, aiming at starting clinical studies during first half of 2012.
LAS190792 will be developed in the Genuair® inhaler, a novel, state-of-the-art, multi-dose dry powder inhaler. It incorporates significant safety features, including one hand dosing, visible dose indicator, an anti-double dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler, as well as audio feedback to confirm successful dose intake. Genuair® is a registered trademark owned by Almirall, S.A.
After aclidinium bromide (monotherapy planned to be filed in mid 2011) and LAS100977 (LABA) + ICS (currently in phase II), this MABA is the third NCE developed by Almirall which will utilize the Genuair® inhaler system.
About COPD
The World Health Organisation (WHO) has described COPD as a global epidemic; an estimated 210 million people have COPD worldwide and more than 3 million people died of the condition in 2005, which is equal to 5% of all deaths globally that year. Total deaths from COPD are projected to increase by more than 30% in the next 10 years without interventions to cut risks, particularly exposure to tobacco smoke.
In patients with COPD the airways in the lungs typically lose their elasticity, produce excess mucus and become thick and inflamed, limiting the passage of air. The most common symptoms of COPD are breathlessness (or a "need for air"), abnormal sputum (a mix of saliva and mucus in the airway), and a chronic cough. Daily activities, such as walking up a short flight of stairs or carrying a suitcase, can become very difficult as the condition gradually worsens. There are significant unmet needs in the treatment of COPD including limited therapeutic options to improve lung function, reduce symptoms and control exacerbations.
New Research Shows Many Patients With Persistent Cough And Sputum Actually Had Airway Obstruction Consistent With COPD
GlaxoSmithKline (NYSE:
GSK) announced findings from a cross-sectional study which showed
that 26 percent of primary care patients 40 years of age and older with a
history of smoking and symptoms of chronic bronchitis actually had airway
obstruction consistent with chronic obstructive pulmonary disease (COPD) -
yet were not diagnosed with the disease.
The data also show that as age and smoking history increased the
percent of patients with COPD increased - roughly half (49%) of the
patients over 60 years of age with more than a 20-pack year history of
smoking had an FEV(1) (forced expiratory flow in one second)/FVC (forced
vital capacity) ratio consistent with COPD; 40 percent of patients over 50
years of age who had more than a 30-pack year history of smoking also had
FEV(1)/FVC consistent with COPD. For the group over 70 years of age with
more than a 40-pack year history, the percent increased to 72.
Overall, only 4 percent of patients in this study had been diagnosed
with COPD by their clinician. These data were presented in Philadelphia at
CHEST 2008, the annual meeting of the American College of Chest Physicians.
"Understanding the patients who are at greatest risk for having
undiagnosed COPD should help improve disease recognition, diagnosis and
management," said Barbara Yawn, M.D., lead author and director of research
at the Olmsted Medical Center, Rochester, MN. "Spirometry should be
considered in anyone with symptoms and a 10 or greater pack-year smoking
history - which is how we will improve recognition of COPD."
In the study, pre- and post-bronchodilatory spirometry was performed on
all patients. Albuterol was self-administered for determination of post-
bronchodilator FEV(1)/FVC ratio, post-albuterol FEV(1)% of predicted normal
and FEV(1) reversibility. All patients had self-reported symptoms of
chronic bronchitis and were current or previous cigarette smokers with a
history of cigarette smoking of > or = 10 pack-years. COPD was defined as a
post- bronchodilator FEV(1)/FVC < or = 0.7.
COPD is characterized by a progressive airflow limitation that is not
fully reversible and is associated with an abnormal inflammatory response
of the lungs, primarily caused by smoking. The range of conditions
described by COPD, which include chronic bronchitis and emphysema, has led
to confusion about disease terminology and difficulty with diagnosis
especially in the primary care setting. Despite the availability of
effective medicines to help manage the disease, many patients with COPD
remain undiagnosed and under- treated. This study aimed to characterize
airway obstruction, patient characteristics, and patient and provider
awareness and understanding of COPD in primary care patients with symptoms
of chronic bronchitis.
About the Study
This was a multi-center, cross-sectional study of more than 1,200
subjects 40 years of age and older with a minimum 10 pack-year smoking
history and symptoms of chronic bronchitis recruited from primary care
centers. There was no treatment intervention in the study. Each study
subject completed a single visit encompassing all study procedures, which
included two questionnaires completed by each study subject. One
questionnaire was a compilation of the medical research council (MRC)
dyspnea scale, the 12-item Short Form Health Survey (SF-12, version 2), a
modified American Thoracic Society (ATS) respiratory questionnaire, and
additional questions about disease and smoking history, work and non-work
activities missed due to breathing problems. The other questionnaire, The
Lung Function Questionnaire (LFQ), was comprised of seven questions related
to respiratory symptoms, smoking history and age.
About the Lung Function Questionnaire
Data was also presented at CHEST 2008 on the development of the Lung
Function Questionnaire (LFQ), a patient screening tool to help identify
patients at risk for airflow obstruction who are candidates for spirometry
and to help address undiagnosed COPD issues.
The LFQ is being developed in 3 phases: 1) Empirical phase: candidate
questionnaire items were identified and their accuracy evaluated using data
from NHANES III; 2) Qualitative phase: questions identified in phase 1 were
evaluated for clarity by patients/clinicians; 3) Quantitative phase:
ongoing validation study of the LFQ in screening for airway obstruction.
The LFQ contained age, wheeze, dyspnea, smoking and phlegm as questions
being predictive of airflow obstruction. LFQ demonstrates moderate
screening accuracy both in a chronic bronchitis population as well as in a
general population in NHANES. Additional validation studies are underway to
further evaluate LFQ in a general population.
Background on COPD
An estimated 24 million Americans suffer from COPD, which is the fourth
leading cause of death in the United States. COPD is a progressive, life-
threatening lung disease that includes chronic bronchitis and emphysema. It
is characterized by airflow obstruction, a limitation in lung function that
makes it difficult to breathe. Many patients have components of both
chronic bronchitis and emphysema. Symptoms of COPD include chronic cough,
chest tightness, shortness of breath, an increased effort to breathe and
increased mucus production. Typically, patients with COPD develop shortness
of breath during exertion, which continues and gradually worsens. Most
patients also develop a productive, chronic cough. Over time, many patients
suffer from shortness of breath so severe that it interferes with their
most basic daily activities including sleeping, talking, and even dressing.
The gradual loss of lung function, coupled with other symptoms and
exacerbations, often lead to hospitalization and can be disabling and
life-threatening.
GlaxoSmithKline - one of the world's leading research-based
pharmaceutical and healthcare companies - is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, GSK cautions investors that any
forward-looking statements or projections made by GSK, including those made
in this announcement, are subject to risks and uncertainties that may cause
actual results to differ materially from those projected. Factors that may
affect GSK's operations are described under 'Risk Factors' in the 'Business
Review' in the company's Annual Report on Form 20-F for 2007.
GlaxoSmithKline
gsk
GSK) announced findings from a cross-sectional study which showed
that 26 percent of primary care patients 40 years of age and older with a
history of smoking and symptoms of chronic bronchitis actually had airway
obstruction consistent with chronic obstructive pulmonary disease (COPD) -
yet were not diagnosed with the disease.
The data also show that as age and smoking history increased the
percent of patients with COPD increased - roughly half (49%) of the
patients over 60 years of age with more than a 20-pack year history of
smoking had an FEV(1) (forced expiratory flow in one second)/FVC (forced
vital capacity) ratio consistent with COPD; 40 percent of patients over 50
years of age who had more than a 30-pack year history of smoking also had
FEV(1)/FVC consistent with COPD. For the group over 70 years of age with
more than a 40-pack year history, the percent increased to 72.
Overall, only 4 percent of patients in this study had been diagnosed
with COPD by their clinician. These data were presented in Philadelphia at
CHEST 2008, the annual meeting of the American College of Chest Physicians.
"Understanding the patients who are at greatest risk for having
undiagnosed COPD should help improve disease recognition, diagnosis and
management," said Barbara Yawn, M.D., lead author and director of research
at the Olmsted Medical Center, Rochester, MN. "Spirometry should be
considered in anyone with symptoms and a 10 or greater pack-year smoking
history - which is how we will improve recognition of COPD."
In the study, pre- and post-bronchodilatory spirometry was performed on
all patients. Albuterol was self-administered for determination of post-
bronchodilator FEV(1)/FVC ratio, post-albuterol FEV(1)% of predicted normal
and FEV(1) reversibility. All patients had self-reported symptoms of
chronic bronchitis and were current or previous cigarette smokers with a
history of cigarette smoking of > or = 10 pack-years. COPD was defined as a
post- bronchodilator FEV(1)/FVC < or = 0.7.
COPD is characterized by a progressive airflow limitation that is not
fully reversible and is associated with an abnormal inflammatory response
of the lungs, primarily caused by smoking. The range of conditions
described by COPD, which include chronic bronchitis and emphysema, has led
to confusion about disease terminology and difficulty with diagnosis
especially in the primary care setting. Despite the availability of
effective medicines to help manage the disease, many patients with COPD
remain undiagnosed and under- treated. This study aimed to characterize
airway obstruction, patient characteristics, and patient and provider
awareness and understanding of COPD in primary care patients with symptoms
of chronic bronchitis.
About the Study
This was a multi-center, cross-sectional study of more than 1,200
subjects 40 years of age and older with a minimum 10 pack-year smoking
history and symptoms of chronic bronchitis recruited from primary care
centers. There was no treatment intervention in the study. Each study
subject completed a single visit encompassing all study procedures, which
included two questionnaires completed by each study subject. One
questionnaire was a compilation of the medical research council (MRC)
dyspnea scale, the 12-item Short Form Health Survey (SF-12, version 2), a
modified American Thoracic Society (ATS) respiratory questionnaire, and
additional questions about disease and smoking history, work and non-work
activities missed due to breathing problems. The other questionnaire, The
Lung Function Questionnaire (LFQ), was comprised of seven questions related
to respiratory symptoms, smoking history and age.
About the Lung Function Questionnaire
Data was also presented at CHEST 2008 on the development of the Lung
Function Questionnaire (LFQ), a patient screening tool to help identify
patients at risk for airflow obstruction who are candidates for spirometry
and to help address undiagnosed COPD issues.
The LFQ is being developed in 3 phases: 1) Empirical phase: candidate
questionnaire items were identified and their accuracy evaluated using data
from NHANES III; 2) Qualitative phase: questions identified in phase 1 were
evaluated for clarity by patients/clinicians; 3) Quantitative phase:
ongoing validation study of the LFQ in screening for airway obstruction.
The LFQ contained age, wheeze, dyspnea, smoking and phlegm as questions
being predictive of airflow obstruction. LFQ demonstrates moderate
screening accuracy both in a chronic bronchitis population as well as in a
general population in NHANES. Additional validation studies are underway to
further evaluate LFQ in a general population.
Background on COPD
An estimated 24 million Americans suffer from COPD, which is the fourth
leading cause of death in the United States. COPD is a progressive, life-
threatening lung disease that includes chronic bronchitis and emphysema. It
is characterized by airflow obstruction, a limitation in lung function that
makes it difficult to breathe. Many patients have components of both
chronic bronchitis and emphysema. Symptoms of COPD include chronic cough,
chest tightness, shortness of breath, an increased effort to breathe and
increased mucus production. Typically, patients with COPD develop shortness
of breath during exertion, which continues and gradually worsens. Most
patients also develop a productive, chronic cough. Over time, many patients
suffer from shortness of breath so severe that it interferes with their
most basic daily activities including sleeping, talking, and even dressing.
The gradual loss of lung function, coupled with other symptoms and
exacerbations, often lead to hospitalization and can be disabling and
life-threatening.
GlaxoSmithKline - one of the world's leading research-based
pharmaceutical and healthcare companies - is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, GSK cautions investors that any
forward-looking statements or projections made by GSK, including those made
in this announcement, are subject to risks and uncertainties that may cause
actual results to differ materially from those projected. Factors that may
affect GSK's operations are described under 'Risk Factors' in the 'Business
Review' in the company's Annual Report on Form 20-F for 2007.
GlaxoSmithKline
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