Chest
Original Research: COPDPooled Clinical Trial Analysis of Tiotropium Safety
Section snippets
Study Population
Inclusion criteria for entry into the pooled safety database were completed clinical trials in the tiotropium HandiHaler (Boehringer Ingelheim International GmbH; Ingelheim, Germany) project database as of May 2004 with the following characteristics: tiotropium (18 μg qd), placebo-controlled, and parallel-group study design. The 18-μg dosage included in the pooled analysis was chosen because of the relatively smaller amount of data for other doses, and to reflect the use of the approved dose of
Results
The pooled trial population presents information on 7,819 patients from 19 clinical trials, including 4,435 tiotropium-treated patients and 3,384 placebo-treated patients, contributing 2,159 person-years of exposure to tiotropium and 1,662 person-years of exposure to placebo. The distributions of treatment groups according to demographics baseline disease characteristics and duration of exposure are shown in Table 1. The study population was balanced between the tiotropium and placebo groups.
Discussion
Marketing approval of pharmaceutical products is generally based on review of trials often containing several thousand exposed subjects in controlled trials and concluding that a drug has a favorable risk/benefit profile. The evaluation of safety continues beyond the core registration trials and can include phase IV trials, as well as retrospective studies based on claims databases and spontaneous reporting of adverse events. Tiotropium was initially approved and marketed in several countries
ACKNOWLEDGMENT
The authors thank Terry Keyser, Boehringer Ingelheim, Ridgefield, CT, for editorial support in preparation of this article.
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Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).
This study was supported by Boehringer Ingelheim Pharmaceuticals Inc. and Pfizer Inc.
Drs. Kesten and Lanes are employees of Boehringer Ingelheim. Dr. Jara and Mr. Wentworth are consultants for Boehringer Ingelheim.