Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses.

Objectives: To conduct a systematic review and meta-analysis of the effects of rosiglitazone treatment on cardiovascular risk and mortality using multiple data sources and varying analytical approaches with three aims in mind: to clarify uncertainties about the cardiovascular risk of rosiglitazone; to determine whether different analytical approaches are likely to alter the conclusions of adverse event meta-analyses; and to inform efforts to promote clinical trial transparency and data sharing.

Design: Systematic review and meta-analysis of randomized controlled trials.

Data Sources: GlaxoSmithKline's (GSK's) ClinicalStudyDataRequest.