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16 October 2007 | Volume 147 Issue 8 | Pages 578-581
A recent, widely publicized meta-analysis of 42 clinical trials concluded that rosiglitazone was associated with an approximately 43% increased risk for myocardial infarction and an approximately 64% increased risk for cardiovascular death. The sensitivity of these conclusions to several methodological choices was not assessed. The meta-analysis was not based on a comprehensive search for all studies that might yield evidence about rosiglitazone's cardiovascular effects. Studies were combined on the basis of a lack of statistical heterogeneity, despite substantial variability in study design and outcome assessment. The meta-analytic approach that was used required the exclusion of studies with zero events in the treatment and control groups. Alternative meta-analytic approaches that use continuity corrections show lower odds ratios that are not statistically significant. We conclude that the risk for myocardial infarction and death from cardiovascular disease for diabetic patients taking rosiglitazone is uncertain: Neither increased nor decreased risk is established.
Author and Article Information
From Cedars-Sinai Medical Center and David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.
Potential Financial Conflicts of Interest: None disclosed.
Requests for Single Reprints: Sanjay Kaul, MD, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048; e-mail, kaul{at}cshs.org.
Current Author Addresses: Dr. Diamond: 2408 Wild Oak Drive, Los Angeles, CA 90068; e-mail, gadiamond{at}pol.net.
Mr. Bax: Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht, the Netherlands, and Department of Medical Informatics, Kitasato University, Kitasato 1-15-1, Sagamihara 228-8555, Japan; e-mail, leonbax{at}kitasato-u.ac.jp.
Dr. Kaul: Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048; e-mail, kaul{at}cshs.org. PERSPECTIVE
Uncertain Effects of Rosiglitazone on the Risk for Myocardial Infarction and Cardiovascular Death
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