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New data show SPIRIVA® significantly reduced exacerbations and related health care utilization in patients with COPD

Pressmeddelande   •   Maj 24, 2004 08:47 CEST

SPIRIVA® (tiotropium) significantly reduced exacerbations and health care utilization in patients with Chronic Obstructive Pulmonary Disease (COPD), according to the results of a study presented today at the 100th international conference of the American Thoracic Society.1 This is the only study with exacerbations as one of the primary endpoints performed in a large COPD patient population. SPIRIVA® is a novel, inhaled anticholinergic medication recommended for the first-line maintenance treatment of COPD with once-daily dosing.

COPD is a slowly progressive airway disease that causes significant deterioration of lung function and chronic breathlessness that can lead to severe disability.2 Currently, COPD is the fourth leading cause of death worldwide, alongside HIV/AIDS.3 The World Health Organization estimates that by 2020, COPD will be the third leading cause of death and the fifth leading cause of disability in the world.4

The trial design had a number of characteristics making it a landmark study in COPD exacerbations: a rigorous definition of exacerbations; pre-specified co-primary endpoints of exacerbations/hospitalizations; broad patient eligibility criteria and intention-to-treat analyses for the full observation period. The study was performed in a total of 1,829 patients randomized to receive either SPIRIVA® or placebo, both in addition to usual care, which included treatment with other bronchodilators and inhaled corticosteroids.

In this study, the addition of SPIRIVA® to usual care significantly reduced the percentage of patients with exacerbations compared to placebo in addition to usual care (27.9% vs 32.3%; p=0.037) and reduced associated hospitalizations (7.0% vs 9.5%; p=0.056).1

Additionally, SPIRIVA®:1


significantly reduced the number of exacerbations, per patient year, (0.853 vs 1.051; p=0.003)
significantly reduced the number of exacerbation days, per patient year, (mean: 12.61 vs 15.96 days; p<0.001)
significantly delayed the time to first exacerbation and associated hospitalization (both p<0.05) and reduced the number of treatment days (antibiotic or steroids) for exacerbation (p<0.001)
significantly reduced hospitalizations, per patient year, (mean: 0.177 vs 0.253; p=0.013)
significantly reduced unscheduled clinic visits, per patient year, (mean: 0.39 vs 0.49; p=0.017).
“Guidelines state that exacerbations are one of the key targets for COPD therapy because of the negative impact they have on a patient’s quality of life - increasing the level of disability associated with the disease. They are also expensive to treat as additional medication, unscheduled physician visits and hospitalization may be required,” commented Professor Dennis Niewoehner of Pulmonary Division, Veteran Affairs Medical Center and principal investigator for the study. “These study results indicate that SPIRIVA® can play an important role in reducing the enormous human and economic costs that result from COPD exacerbations.”

In this prospective, randomized, double-blind, parallel-group study, exacerbations were defined as an increase in, or new onset of, one or more of the following: cough, sputum, wheezing, dyspnea or chest tightness, lasting three or more days and requiring treatment with antibiotics, steroids or hospitalization. The study was performed in the US Veteran Affairs Medical System.

About SPIRIVA®
SPIRIVA®, a novel inhaled anticholinergic medication, is the first inhaled treatment to provide significant and sustained improvements in lung function with once-daily dosing. SPIRIVA® works through targeting of a dominant reversible mechanism of COPD – cholinergic constriction. SPIRIVA® helps COPD patients breathe easier by opening narrowed airways and helping to keep them open for 24 hours. According to treatment guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), long-acting bronchodilators such as SPIRIVA® are the preferred treatment option for COPD maintenance therapy.

The SPIRIVA® clinical trials programme has recruited over 9,400 patients.5 SPIRIVA® has demonstrated significant and sustained bronchodilation (expansion of the lungs airways).6-8 SPIRIVA® also demonstrated improvements in lung function (FEV1) over ATROVENT® (ipratropium bromide) Inhalation Aerosol, a current first-line therapy for COPD, which were maintained over one year.6,7 In addition, in one-year, placebo-controlled studies, patients treated with SPIRIVA® required fewer doses of rescue medications.8

In clinical trials, the most common adverse reaction reported with SPIRIVA® was dry mouth, which was usually mild and often resolved during treatment.6,8

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 152 affiliates in 45 countries and more than 34,000 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 2003, Boehringer Ingelheim posted net sales of 7.4 billion euro while spending more than one fifth of net sales in its largest business segment Prescription Medicines on research and development.

About Pfizer Inc
Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world’s best-known consumer products.

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