Risk-Benefit and Cost-Effectiveness Assessments of the Statins

Abstract

Objective: To undertake a risk-benefit assessment of the statins with particular emphasis on determining whether serious adverse drug events associated with cerivastatin could have been predicted from its clinical trials and to report on sources of heterogeneity of cost-effective estimates in economic evaluations of the statins. Methods: Randomized controlled trials (RCTs) of cerivastatin and economic evaluations of the statins were retrieved by systematic searches of databases, historical searches, and writing to manufacturers and other authors of published searches of databases, and writing to manufacturers and other authors of published reports. The adverse events data reported (myalgia, increased CK levels greater than ten times the ULN, ALT levels greater than three times the ULN) in the RCTs were pooled using risk difference meta-analysis. The economic evaluation studies were assessed qualitatively. Results: The results from the meta-analyses showed that the adverse drug events profile of cerivastatin could not have been deduced from the clinical trials. There were no significant differences in the rates of adverse events occurrences between cerivastatin