DOI: 10.1101/19000463Jun 25, 2019Paper

Updating Insights into Rosiglitazone and Cardiovascular Risk through Shared Data: Individual Patient-and-Summary-Level Meta-Analyses

MedRxiv : the Preprint Server for Health Sciences

Abstract

Objective: To conduct a systematic review and meta-analysis of the effects of rosiglitazone therapy on cardiovascular risk and mortality using multiple data sources and varying analytical approaches. Design: Systematic review and meta-analysis of randomized controlled trials. Data sources: GlaxoSmithKline's (GSK) Clinical Study Data Request (CSDR) and Study Register platforms, MEDLINE, PubMed, Embase, Web of Science, Cochrane Central Registry of Controlled Trials, Scopus, and ClinicalTrials.gov from inception to January 2019. Study selection criteria: Randomized, controlled, phase II-IV clinical trials comparing rosiglitazone with any control for at least 24 weeks in adults. Data extraction and synthesis: For analyses of trials for which individual patient-level data (IPD) were available, we examined a composite of the following events as our primary outcome: acute myocardial infarction, heart failure, cardiovascular-related deaths, and non-cardiovascular-related deaths. As secondary analyses, these four events were examined independently. When also including trials for which IPD were not available, we examined myocardial infarction and cardiovascular-related deaths, ascertained from summary-level data. Multiple meta-analyses w...Continue Reading

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