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Established Safety Profile of Spiriva Confirmed by 30 Rigorously Controlled Clinical Trials and the Landmark Trial UPLIFT
Date:9/23/2008

New Data from Landmark UPLIFT Trial Further Supports Spiriva's Safety Profile

RIDGEFIELD, Conn. and NEW YORK, Sept. 23 /PRNewswire/ -- Boehringer Ingelheim and Pfizer Inc have released a new analysis of 30 rigorously controlled clinical trials, including UPLIFT, confirming the long term safety profile of Spiriva(R) HandiHaler(R) (tiotropium bromide inhalation powder). The new and expanded safety data contradicts the conclusions about tiotropium in an article by Singh et al. published in the September 24th issue of the Journal of the American Medical Association.(1) Both companies considered it important to release these data to ensure doctors have the most comprehensive, up-to-date safety information on tiotropium in order to make the best treatment decisions for their patients.

Because COPD (Chronic Obstructive Pulmonary Disease) patients have in general a higher cardiovascular risk than the average population(2), cardiovascular safety in a COPD medication is of critical importance. Therefore Boehringer Ingelheim has put special emphasis on the broad investigation of Spiriva including its cardiovascular safety.

The latest analysis of 30 placebo-controlled double-blind, randomized trials with data from 19,545 COPD patients (tiotropium 10,846, placebo 8,699) conducted by Boehringer Ingelheim demonstrated that there is no increased risk of death (all-cause) or death due to cardiovascular events in patients treated with Spiriva, specifically:

-- No increased risk of total (all-cause) mortality (relative risk ratio

for all cause mortality= 0.88, 95% CI=0.77, 0.999)

-- No increased risk of mortality due to cardiac (relative risk ratio for

mortality due to cardiac events= 0.77, CI = 0.55, 1.03) and vascular

events (relative risk ratio for mortality due to vascular events= 0.44,

95% CI = 0.19, 1.02).

-- No increased risk in stroke (relative risk ratio for stroke = 1.03, 95%


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SOURCE Boehringer Ingelheim; Pfizer Inc
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