George A. Diamond, MD; Leon Bax, MSc; Sanjay Kaul, MD
Potential Financial Conflicts of Interest: None disclosed.
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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, email@example.com.
Dr. Kaul: Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048; e-mail, firstname.lastname@example.org.
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.
Table 1. Meta-analytic Odds Ratios for Myocardial Infarction and Cardiovascular Death
Table 2. Meta-analytic Odds Ratios for Subgroups
Appendix Table. Sample Application of Continuity Corrections
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Diamond GA, Bax L, Kaul S. Uncertain Effects of Rosiglitazone on the Risk for Myocardial Infarction and Cardiovascular Death. Ann Intern Med. 2007;147:578-581. doi: 10.7326/0003-4819-147-8-200710160-00182
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Published: Ann Intern Med. 2007;147(8):578-581.
Acute Coronary Syndromes, Cardiology, Coronary Heart Disease, Emergency Medicine.
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