Protocol for analyses of adverse event data from randomized controlled trials of statin therapy

Am Heart J. 2016 Jun;176:63-9. doi: 10.1016/j.ahj.2016.01.016. Epub 2016 Jan 28.


The Cholesterol Treatment Trialists' (CTT) Collaboration was originally established to conduct individual participant data meta-analyses of major vascular events, cause-specific mortality, and site-specific cancers in large, long-term, randomized trials of statin therapy (and other cholesterol-modifying treatments). The results of the trials of statin therapy and their associated meta-analyses have shown that statins significantly reduce the risk of major vascular events without any increase in the risk of nonvascular causes of death or of site-specific cancer, but do produce small increases in the incidence of myopathy, diabetes, and, probably, hemorrhagic stroke. The CTT Collaboration has not previously sought data on other outcomes, and so a comprehensive meta-analysis of all adverse events recorded in each of the eligible trials has not been conducted. This protocol prospectively describes plans to extend the CTT meta-analysis data set so as to provide a more complete understanding of the nature and magnitude of any other effects of statin therapy.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cardiovascular Diseases* / blood
  • Cardiovascular Diseases* / prevention & control
  • Cholesterol / blood*
  • Drug-Related Side Effects and Adverse Reactions* / prevention & control
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / pharmacology*
  • Meta-Analysis as Topic*
  • Randomized Controlled Trials as Topic
  • Research Design


  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Cholesterol