Boehringer Ingelheim Pharmaceuticals, Inc. Release: Spiriva Improved Lung Function In COPD Patients Of African Descent
SAN DIEGO, May 21 /PRNewswire/ -- New study results show that treatment with Spiriva(R) HandiHaler(R) (tiotropium bromide inhalation powder) significantly improved lung function in patients of African descent with COPD, chronic obstructive pulmonary disease.(1) The findings are important because COPD patients of African descent have been under-represented in clinical trials and may respond differently to COPD treatment than Caucasians do.(11) The study results were announced today at the American Thoracic Society's annual meeting.
"These data are an important contribution establishing tiotropium as an effective treatment in patients of African descent," said lead study author, Gerald J. Criner, M.D., FCCP, Professor of Medicine and Director, Temple Lung Center, Temple University School of Medicine.
COPD is primarily a disease of current and former smokers. Nearly 12 million Americans have been diagnosed with COPD, (2) but as many as 24 million may have impaired lung function.(3) While people of African descent represent less than 10 percent of COPD patients,(2) they appear to be more susceptible to developing severe disease at a younger age despite similar levels of smoking.(4)
About the study
The eight-week, randomized, double-blind study included 160 COPD patients of African descent. The study compared Spiriva 18 micrograms (n=78) once daily vs. placebo (n=82).(1) Both agents were administered through the HandiHaler(R) device.(1) The primary endpoint was average improvement in lung function during first 3 hours after drug administration, after 8 weeks of treatment. A common measure of lung function, FEV1 is the forced expiratory volume in one second, or the volume of air exhaled in one second after taking a deep breath.(1)
The results showed that COPD patients treated with Spiriva demonstrated a significant improvement in all lung function parameters measured.(1) More specifically, estimated average FEV1 after drug administration was 180 milliliters greater in Spiriva patients versus those treated with placebo as compared to baseline.(1) There was no significant difference in the frequency of rescue medication use and the UCSD Shortness of Breath Questionnaire total score (59.92 Spiriva group; 57.355 placebo group). Adverse events, including exacerbations, were monitored throughout the study period. The overall incidence of adverse events was lower in the tiotropium group compared with the placebo group. While the most commonly reported adverse event was exacerbations, there were no exacerbations in the tiotropium group compared to 12 in the placebo group.
The study was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. and Pfizer Inc.
COPD is the second-leading cause of disability(5) and the fourth-leading cause of death in the U.S.(6) It is projected to become the third-leading fatal illness by 2020.6 While it is primarily caused by cigarette smoking, other causes of COPD include exposure to occupational dusts and chemicals.(6) There is also a link between COPD and a rare genetic disorder involving a deficiency in the enzyme alpha1-antitrypsin (AAT) that normally prevents loss of elasticity in the lungs' fibers.(7)
The most common COPD symptoms include shortness of breath, chronic cough (sometimes with phlegm), and wheezing.(6) COPD is often associated with exacerbations of these symptoms,(7) which can account for a high proportion of health-care costs associated with the disease -- nearly $40 billion in the U.S.(8) In the last 20 years, COPD was also responsible for nearly 50 million hospital visits nationwide.(9)
COPD is, however, a manageable disease.(7) According to diagnosis and treatment guidelines set by the Global Initiative for Chronic Obstructive Lung Disease (GOLD), intervention can help treat some of the symptoms of COPD.(7)
About Spiriva(R) HandiHaler(R) (tiotropium bromide inhalation powder)
Spiriva HandiHaler is a once-a-day, regular (maintenance) treatment for bronchospasm (airway narrowing) associated with COPD, including chronic bronchitis and emphysema. Spiriva is contraindicated in patients with a hypersensitivity to atropine or its derivatives -- i.e., ipatropium or any components of this product. Spiriva is not for treating sudden breathing problems. The most common side effect is dry mouth. It is usually mild and goes away with continued use.
Please see http://www.spiriva.com for full prescribing information.
Consumers who need help paying for medicine, or who know someone who needs help, can call 1-888-4PPA-NOW (1-888-477-2669) or go to http://www.pparx.org.
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 is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and approximately 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 US $11.8 billion (9.5 billion euro) while spending approximately 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.
Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world's best- known consumer products.
For further information on Pfizer, please see http://www.pfizer.com. References: (1) "Efficacy of Tiotropium Inhalation Powder in COPD Patients of African Descent," GJ Criner, ATS Poster, 2006 (2) Centers for Disease Control. Summary health statistics for U.S. adults: National Health Interview Survey, 2003. National Center for Health Statistics. Vital Health Stat 10(225). 2005. Table 3. Available at: http://www.cdc.gov/nchs/data/series/sr_10/sr10_225.pdf. (3) Mannino DM, Homa DM, Akinbami LJ, et al. Chronic obstructive pulmonary disease surveillance- United States, 1971-2000. MMWR. Surveillance Summaries, August 2, 2002/51 (SS06); 1-16. (4) Chatila WM, Wynkoop WA, Vance G, Criner GJ. Temple University Hospital, Philadelphia, PA. "Smoking Patterns in African Americans and Whites with Advanced COPD"; CHEST(R), The Cardiopulmonary and Critical Care Journal 2004:125;15-21 (5) Beers MH, ed. The Merck Manual-Second Home Edition. Chronic obstructive pulmonary disease. Available at: http://www.merck.com/mmhe/sec04/ch045/ch045a.html. (6) National Heart, Lung, and Blood Institute. Data Fact Sheet: Chronic Obstructive Pulmonary Disease (COPD). Available at http://www.nhlbi.nih.gov/health/public/lung/other/copd_fact.pdf. Accessed June 25, 2004. (7) Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. NHLBI/WHO workshop report. Bethesda, National Heart, Lung and Blood Institute, April 2001; Updated September 2005. Available at http://www.goldcopd.com. (8) National Institutes of Health. NHLBI Morbidity & Mortality: 2004 Chart Book on Cardiovascular, Lung * Blood Diseases. May 2004. Available at: http://www.nhlbi.nih.gov/resources,/docs/cht-book.htm. (9) Holguin F, Folch E, Redd SC, Mannino DM. Comorbidity and mortality in COPD-related Hospitalizations in the United States, 1979-2001*. Chest, October 2005. 2005-2011. (10) Spiriva HandiHaler (tiotropium bromide inhalation powder) Prescribing Information. Boehringer Ingelheim and Pfizer 2004. Available at http://www.spiriva.com. (11) Hankinson JL, Odencrantz JR, Fedan KB. Am J Respir Crit Care Med. 1999;159:179-187. Contact: Lara Crissey Paul Ewing Boehringer Ingelheim Pharmaceuticals, Inc. Pfizer Inc 203-798-4740 (office) 212-733-0179 (office) 203-482-4073 (mobile) 917-715-1547 (mobile)Boehringer Ingelheim Pharmaceuticals, Inc.
CONTACT: Lara Crissey of Boehringer Ingelheim Pharmaceuticals, Inc.,office - +1-203-798-4740, mobile - +1-203-482-4073; Paul Ewing of PfizerInc, office - +1-212-733-0179, mobile - +1-917-715-1547