Clinical trials : journal of the Society for Clinical Trials
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A meta-analysis of randomized controlled trials suggested that rosiglitazone, a drug used for the treatment of diabetes, may be associated with an increased risk of cardiovascular adverse events. Three large randomized trials, designed specifically to address cardiovascular outcomes of rosiglitazone treatment, have published new or updated results. ⋯ Rosiglitazone appears to be associated with an increased risk of myocardial infarction and heart failure, but not death due to cardiovascular causes. When a meta-analysis of rare events is contemplated, a thorough sensitivity analysis using different methods to combine studies and an evaluation of different continuity corrections should be undertaken. When possible, an individual patient data meta-analysis should be performed, allowing time-to-event analysis and the identification of patient subgroups at an increased risk of adverse outcomes.