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Original press release at
New Data Shows SPIRIVA(R) HandiHaler(R) Reduced Exacerbations and
Related Health Care Utilization in Patients With COPD
Sunday May 23, 5:09 pm ET
ORLANDO, May 23 /PRNewswire-FirstCall/ -- In investigational studies
tiotropium bromide inhalation powder (SPIRIVA® HandiHaler®) reduced
exacerbations and health care
utilization in patients with Chronic Obstructive Pulmonary Disease (COPD),
according to the results of a clinical study presented today at the 100th
conference of the American Thoracic Society.(1) SPIRIVA HandiHaler was
recently approved by the FDA for the long- term once-daily maintenance
treatment of bronchospasm
associated with COPD, including chronic bronchitis and emphysema.
COPD exacerbations are episodic worsenings characterized by increased
symptoms, often requiring treatment intervention and sometimes
hospitalization. COPD exacerbations
and associated hospitalizations are associated with significant morbidity,
mortality, health resources utilization and cost.
The main objectives of this large scale study were to evaluate the effect
of treatment with tiotropium on the incidence and frequency of
exacerbations and associated
hospitalizations during a six month study period. Study sites at 26
Veteran Affairs Medical Centers across the United States participated in
this randomized, double-
blind, placebo controlled trial. A total of 1,829 patients were randomized
to receive either tiotropium or placebo. Patients were permitted to
continue using previously
prescribed respiratory medications, with the single exception of
anticholinergics agents other than study drug.
Pre-specified co-primary endpoints of the study were the percentage of
patients experiencing at least one exacerbation and the percentage of
patients experiencing at
least one hospitalization for an exacerbation during the treatment period.
Exacerbations were defined by presence of greater than or equal to 2 new
respiratory symptoms (i.e. cough, sputum, wheezing, breathlessness or
chest tightness) for a duration of at least 3 days and requiring treatment
systemic steroids and/or hospitalization.
During the treatment period, tiotropium resulted in a significant
reduction in the percentage of patients with greater than or equal to 1
exacerbation compared to placebo
(27.9% vs 32.3%; p=0.037) and a decrease in the percentage of patients who
experienced greater than or equal to 1 hospitalizations (7.0% vs 9.5%;
Additionally, tiotropium significantly reduced the number of exacerbations
(0.853 vs 1.051 exacerbations per patient-year; p=0.003) (1) and number of
(mean: 12.61 vs 15.96 days per patient year; p<0.001)(1). Similarly,
tiotropium significantly reduced the frequency of exacerbation related
hospitalizations (0.177 vs
0.253 means hospitalizations per patient year, p=0.013)(1) and the number
of hospitalization days (1.433 vs. 1.702, mean days per patient year,
p=0.001) compared to
placebo. In addition, a reduction in the number of treatment days
(antibiotic or steroids) (p<0.001)(1) and unscheduled visits to health
care providers for exacerbations
(p = 0.017) were also significantly reduced with tiotropium compared to
"Guidelines state that exacerbations are one of the key targets for COPD
therapy because they increase the level of disability associated with the
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.
COPD is a slowly progressive disease of the airways that is characterized
by a loss of lung function over time.(2) The signs and symptoms patients
may experience are
chronic cough, excess mucus production, wheezing and shortness of breath
even after mild exertion. COPD is often associated with exacerbations of
these symptoms which can
account for a high proportion of health care costs associated with this
disease. COPD is primarily caused by smoking.(2) There are an estimated 24
million US adults who
suffer from COPD, but only 10 million have been diagnosed. Globally, this
disabling disease is the fourth leading cause of death claiming 2.74
million lives annually.(3)
About Tiotropium Bromide Inhalation Powder
Tiotropium is indicated for the long-term, once-daily, maintenance
treatment of bronchospasm associated with COPD, including chronic
bronchitis and emphysema. Tiotropium
is not indicated for rescue therapy and is contraindicated in patients
with a history of hypersensitivity to atropine or its derivates or to any
component of this
product. The most common adverse reaction was dry mouth, which was usually
mild and often resolved during treatment.(4)
About Boehringer Ingelheim
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 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,
marketing novel products of high therapeutic value for human and
In 2003, Boehringer Ingelheim posted net sales of US $8.37 billion (7.4
billion euro) while spending more than one fifth of net sales in its
largest business segment,
Prescription Medicines, on research and development.
For more information please visit http://www.boehringer-ingelheim.com.
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. For
further information on Pfizer, please see http://www.pfizer.com
Source: Boehringer Ingelheim Pharmaceuticals, Inc.; Pfizer Inc
1. Niewoehner D, Rice K, Cote C, et al. Reduced COPD
associated health care utilization with once-daily tiotropium
the VA Medical System. Abstract presented at ATS 2004, Orlando
Florida. 21-26 May 2004.
2. National Heart, Lung, and Blood Institute. Data Fact Sheet:
Obstructive Pulmonary Disease (COPD).
December 2002 .
3. World Health Organization. World health report 2003.
Annex. Annex table 2: 154-159
4. Spiriva(R) HandiHaler(R) (tiotropium bromide inhalation powder)
Prescribing Information. Boehringer Ingelheim and Pfizer 2004.
Available at www.spiriva.com
Source: Boehringer Ingelheim Pharmaceuticals, Inc.; Pfizer Inc
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