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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

CI = 0.79, 1.35), and

-- No increased risk for myocardial infarction (relative risk ratio for

myocardial infarction 0.78, 95% CI = 0.59, 1.02) associated with

tiotropium.(3)

The UPLIFT results demonstrate that there is no increased risk of total mortality or cardiovascular mortality in COPD patients treated with Spiriva.

"We strongly disagree with the conclusion reached by Singh et al. We have disclosed to regulatory authorities worldwide this important information, which is part of a very robust analysis of all our double-blind, placebo-controlled, parallel group trials with a duration of at least 4 weeks. Our analysis, which includes data from the four-year UPLIFT trial, supports the safety profile of Spiriva," commented Dr Andreas Barner, Vice Chairman of the Board of Managing Directors at Boehringer Ingelheim, responsible for Research, Development and Medicine. "Patients and physicians can be confident that Spiriva is a safe and effective medication. In clinical trials and since its introduction, we have collected extensive safety data adding up to an exposure of more than 10 million patient years."

Peer-reviewed meta-analyses of aggregate published data like Singh et al have their appropriate place in scientific research. However, these analyses have well-recognized limitations, such as combining study summaries rather than analyzing individual patient data, or not correcting for patients who dropped out of trials early.

Most of the evidence in the analysis by Dr. Singh and colleagues is contributed by a single study, the Lung Health Study, involving a different anticholinergic medication, ipratropium. In this study, most of the cardiovascular deaths occurred among patients who were not using their medication. Other limitations include the inability to adjust for treatment duration and accounting for patients who discontinue the trial early, apparent double-counting of trials and combining placebo and
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SOURCE Boehringer Ingelheim; Pfizer Inc
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