Original press release at http://www.prnewswire.com dated 5/23

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 international 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.
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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 of increased
respiratory symptoms (i.e. cough, sputum, wheezing, breathlessness or
chest tightness) for a duration of at least 3 days and requiring
treatment with antibiotics, 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%; p=0.056).(1)

Additionally, tiotropium significantly reduced the number of
exacerbations (0.853 vs 1.051 exacerbations per patient-year; p=0.003)
(1) and number of exacerbation days (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
placebo.

"Guidelines state that exacerbations are one of the key targets for
COPD therapy because they increase the level of disability associated
with the disease. Exacerbations 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, manufacturing
and marketing novel products of high therapeutic value for human and
veterinary medicine.

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

References

1. Niewoehner D, Rice K, Cote C, et al. Reduced COPD
exacerbations and
associated health care utilization with once-daily tiotropium
(TIO) in
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:
Chronic
Obstructive Pulmonary Disease (COPD).
December 2002 .
3. World Health Organization. World health report 2003.
Statistical
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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