Do statins cause cancer? A meta-analysis of large randomized clinical trials

Am J Med. 2001 Jun 15;110(9):716-23. doi: 10.1016/s0002-9343(01)00705-7.


Purpose: Although the short-term safety and tolerability of statins has been well established, their potential carcinogenicity in the long term is still debated. The goal of this study was to determine whether long-term treatment with statins is associated with an increased risk of fatal and nonfatal cancers.

Methods: We searched the Medline database between January 1966 and December 1999 for randomized, controlled trials of human subjects in which monotherapy with a statin was compared with placebo. No language restrictions were applied. Only trials with a minimum treatment duration of 4 years and a minimum of 1,000 subjects were included. Studies that did not provide information on fatal or nonfatal cancers were excluded. Data on fatal and nonfatal cancers and all-cause mortality were extracted by a single nonblinded reviewer. Overall crude estimates of risk difference were computed by summing the numerators and denominators of trial-specific risk estimates.

Results: Five trials met the inclusion criteria. The estimated differences in absolute risk between treatment and placebo were as follows (negative risks indicate that treatment was safer than placebo): all nonfatal cancers, 0.0% (95% confidence interval [CI]: -0.8% to 0.8%); all fatal cancers, -0.1% (95% CI: -0.7% to 0.4%); all fatal and nonfatal cancers combined, -0.1% (95% CI: -1.0% to 0.7%); and all-cause mortality, -1.5% (95% CI: 2.8% to 0.2%).

Conclusion: This study demonstrates no association between statin use over a 5-year period and the risk of fatal and nonfatal cancers. This conclusion is limited by the relatively short follow-up of the studies analyzed. Similar analyses of data from studies with longer follow-up periods would be valuable.

Publication types

  • Comparative Study
  • Meta-Analysis

MeSH terms

  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects*
  • Hypolipidemic Agents / adverse effects*
  • Male
  • Middle Aged
  • Neoplasms / etiology*
  • Neoplasms / mortality
  • Placebos
  • Randomized Controlled Trials as Topic


  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Hypolipidemic Agents
  • Placebos