Chest
Original ResearchCOPDCardiovascular Safety of Tiotropium in Patients With COPD
Section snippets
Study Population
The pooled safety database consisted of 30 completed clinical trials as of September 2008 in the tiotropium (Boehringer Ingelheim GmbH; Ingelheim, Germany) project database. For inclusion, all trials used a placebo-controlled, double-blind, and parallel-group study design. Trials were restricted to COPD and of at least 4 weeks' duration. In order to be comprehensive, studies with the dry powder (capsules delivered via the HandiHaler) and soft mist (Respimat) formulations have been included.
The
Study Population
There were 19,545 patients randomized with 8,699 receiving placebo and 10,846 receiving tiotropium. Cumulative exposure to study drug (patient-years) was 13,146 for tiotropium and 11,095 for placebo. Baseline demographics (Table 2) were balanced between treatment groups. The mean age of the population was 65 ± 9 years and 76% were men. Mean baseline FEV1 was 1.15 ± 0.46 L (41 ± 14% predicted), FVC was 2.49 ± 0.82 L (70 ± 19% predicted), and FEV1/FVC was 0.47 ± 0.12. Thirty-four percent of
Discussion
The tiotropium clinical trial program described in this report represents a substantial database of 19,545 patients studied in randomized, double-blind, parallel-group, placebo-controlled trials for up to 4 years. The data set demonstrates reductions in overall adverse events, serious adverse events, and all-cause mortality. Similarly, reductions were observed for CV end points, including a composite CV-mortality end point. In addition, relative to the control group, the clinical trials have
Pooled Terms and the Associated Preferred Terms in Parenthesis Used in the Analyses
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Aneurysm (aneurysm, aneurysm arteriovenous, aneurysm ruptured, aortic aneurysm, aortic aneurysm rupture, aortic aneurysm syphilitic, aortic dissection, aortic dissection rupture, aortic intramural hematoma, artery dissection, cardiac aneurysm, carotid aneurysm rupture, cerebral aneurysm ruptured syphilitic, Charcot-Bouchard microaneurysms, coronary artery aneurysm, coronary artery dissection, dissecting coronary artery aneurysm, femoral artery aneurysm, femoral artery dissection,
Acknowledgments
Author contributions: Dr Celli: contributed to the planning and data analysis and was the primary writer of the manuscript.
Dr Decramer: contributed to the planning, data analysis, and writing of the manuscript.
Dr Leimer: contributed to the collection and analysis of the data as a member of the Boehringer Ingelheim staff.
Dr Vogel: contributed to the collection and analysis of the data as a member of the Boehringer Ingelheim staff.
Dr Kesten: contributed to the access to the data, its analysis and
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Funding/support: This study was funded by Boehringer Ingelheim and Pfizer.
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