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Press Release
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Inhaled Bronchodilators Confirmed as a Preferred Maintenance Therapy in Managing Chronic Obstructive Pulmonary Disease (COPD)
-Current Approaches to COPD Treatment Reviewed in the New England Journal of Medicine-
Ridgefield, CT, June 28 - A review of current treatment guidelines for the management of chronic obstructive pulmonary disease (COPD), published in the June 23, 2004, issue of the New England Journal of Medicine (NEJM), confirms the central role of bronchodilators as a preferred maintenance therapy to optimize the management and treatment of patients with COPD.
According to Peter J. Barnes, M.D., professor of thoracic medicine, Department of Thoracic Medicine, National Heart and Lung Institute, Imperial College, London, "COPD is a major and growing global health problem.1" Barnes also states that COPD "is the only common cause of death in the United States whose prevalence has increased over the past 20 years" and that "among common diseases, COPD has been relatively neglected...1"
According to the NEJM article, inhaled bronchodilators are the foundation of COPD treatment because they improve airflow.2 The article also notes that since most patients have at least moderate airflow limitation when first evaluated, they are likely to require regularly scheduled bronchodilation and to derive benefit from a long-acting bronchodilator as initial therapy.2 The combination of different bronchodilators is recommended before adding other classes of medications.2
The article also notes that theophylline may be prescribed if symptoms continue despite combined inhaled-bronchodilator therapy and that the appropriate role of inhaled corticosteroids in COPD is controversial.2 The NEJM article reports that guidelines therefore recommend that inhaled corticosteroids be considered only for patients with moderate-to-severe airflow limitation who have persistent symptoms despite optimal bronchodilator therapy.2
Long-acting bronchodilators such as Spiriva® HandiHaler® (tiotropium bromide inhalation powder) are the preferred treatment option for COPD maintenance therapy, according to the treatment guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the American Thoracic Society (ATS).3,4] Spiriva is approved by the U.S. Food and Drug Administration for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
"As a long-acting bronchodilator, Spiriva is one of the optimal first-line maintenance therapies for patients with mild to severe COPD and represents a new approach in their COPD treatment paradigm," said Dennis E. Doherty, M.D., chairman of the National Lung Health Education Program and professor of medicine and chief of the Division of Pulmonary and Critical Care Medicine at the University of Kentucky Medical Center in Lexington, Kentucky. "For the first time, patients may be able to breathe easier over a 24-hour period with once-a-day use of Spiriva, reduce their use of rescue medications and achieve a more normal lifestyle."
Spiriva, a novel anticholinergic medication, is the first inhaled treatment with once-daily dosing to provide significant and sustained improvements in lung function of patients with COPD. Spiriva works through targeting of the primary reversible component of COPD - constriction of the airways. Spiriva helps COPD patients breathe easier by opening narrowed airways and helping to keep them open for 24 hours.
About COPD
An estimated 24 million Americans suffer from COPD, a slowly progressive disease of the airways that is characterized by a gradual loss of lung function.5,6 However, only 10 million have self-reported being diagnosed with the disease, with approximately 70 percent under the age of 65.5 Most people with COPD are at least 40 years old or around middle age when symptoms start.7 Common symptoms include chronic cough, excess mucus production, wheezing and shortness of breath after mild exertion.5,6
COPD is the fourth leading cause of death in the United States and is projected to become the third leading fatal illness by 2020.5,6 The Centers for Disease Control and Prevention estimate that 119,000 Americans died of COPD in 2000, with fatalities for women outnumbering men for the first time.5 In 2002, the total annual cost to the nation for COPD was estimated at $32.1 billion.6 Healthcare expenditures accounted for $18 billion, and indirect costs (associated with illness and premature death) were $14.1 billion.6
About Spiriva
Spiriva was discovered and developed by Boehringer Ingelheim and is co-promoted in the U.S. with Pfizer Inc. In long-term clinical trials that included 2,663 patients (1,308 receiving Spiriva), Spiriva demonstrated significant bronchodilation (expansion of the airways) that was sustained over the duration of the studies. Spiriva also demonstrated improvements in lung function (mean FEV1) in two one-year clinical trials over ipratropium bromide, better known as Atrovent® Inhalation Aerosol, a current first-line therapy for COPD. In addition, in two one-year and one six-month placebo-controlled studies, patients treated with Spiriva used fewer doses of rescue medications. Spiriva is not indicated for rescue therapy and is contraindicated in patients with a history with hypersensitivity to atropine or its derivatives or to any component of this product. The most common adverse reaction was dry mouth, which was usually mild and often resolved during treatment. As an anticholinergic drug, Spiriva must be used with caution in patients with narrow angle glaucoma (eye disease), prostatic hyperplasia (abnormal growth of prostate), or bladder-neck obstruction as it may potentially worsen symptoms and signs of these conditions.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group of companies ranks among the 20 leading pharmaceutical corporations in the world. Headquartered in Ingelheim, Germany, it operates globally with 156 affiliates in 44 countries and a total of about 32,000 employees.
Since it was founded in 1885, the family-owned company has been committed to researching, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2002, Boehringer Ingelheim posted net sales of $7.2 billion while spending about one fifth of net sales in its largest business segment Prescription Medicines on research and development.
For more information, please visit http://us.boehringer-ingelheim.com.
About Pfizer Inc.
Pfizer Inc (NYSE: PFE) discovers, develops, manufactures and markets leading prescription medicines for humans and animals and many of the world's best-known consumer brands. For more information about Pfizer, please see www.pfizer.com.
References
- Barnes, PJ. "Perspective: Small Airways in COPD." N Engl J Med 2004;350(26):2635-2637.
- Sutherland, ER, Cherniack, RM. "Current Concepts: Management of Chronic Obstructive Pulmonary Disease." N Engl J Med 2004;350(26):2689-2697.
- Global Initiative for Chronic Obstructive Lung Disease. "Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (Based on an April 1998 NHLBI/WHO Workshop; updated 2003). Available at www.goldcopd.org/revised.pdf. Accessed June 25, 2004.
- American Thoracic Society (ATS) and European Respiratory Society (ERS). COPD-ATS-ERS Task Force. "Standards for the Diagnosis and Treatment of Patients with COPD." April 2004.
- Mannino DM, et al. Centers for Disease Control and Prevention. MMWR. Chronic Obstructive Pulmonary Disease Surveillance, United States, 1971-2000. August 2, 2002/51 (SS06);1-16. Available at www.cdc.gov/mmwr/preview/mmwrhtml/ss5106a1.htm. Accessed June 25, 2004.
- National Heart, Lung, and Blood Institute. Data Fact Sheet: Chronic Obstructive Pulmonary Disease (COPD). Available at www.nhlbi.nih.gov/health/public/lung/other/copd_fact.pdf. Accessed June 25, 2004.
- What Is COPD? Available at www.thebreathingspace.com/libry.htm#What. Accessed June 25, 2004.