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Rosiglitazone is associated with increased risks of myocardial infarction and cardiovascular death of some 43% and 64% respectively, a meta-analysis of 42 clinical trials has found.
However, 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 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.
The authors state that their analysis is restricted by the same limitations as those in the original analysis: short follow-up, low event rates, absence of patient-level data about time to event, variable and probably incomplete outcome ascertainment and inability to reliably assess total mortality rate or composite outcomes, such as death or myocardial infarction.
Ann Intern Med, published early online 7/8/2007