Rosiglitazone was suspended from European markets in 2010 due to evidence suggesting an increased risk of myocardial infarction. However, some studies did not have access to individual patient-level data (IPD) from clinical trials and mostly relied on summary-level data.
This meta-analysis used multiple data sources to clarify uncertainties about the cardiovascular and mortality risk of rosiglitazone and to determine whether different analytical approaches are likely to alter the conclusions.
Data from 21,156 patients from 33 clinical trials with IPD, 22,772 patients examined in 103 trials without IPD were analysed.
Among trials for which IPD were available, rosiglitazone use was consistently associated with an increased cardiovascular risk, especially for heart failure events. Increased myocardial infarction risk was observed across analyses, but the magnitudes of risk were reduced when summary level data were used in addition to IPD. Among trials for which IPD were available, more myocardial infarctions and fewer cardiovascular deaths were reported using IPD compared with summary-level data
Rosiglitazone is associated with increased cardiovascular risk, especially for heart failure events. More myocardial infarctions and fewer cardiovascular-related deaths were reported in the IPD than in the summary level data, therefore sharing IPD might be necessary when performing meta-analyses focused on safety.