Statins, Fibrates, and Melanoma Risk: a Systematic Review and Meta-analysis

Background: Large randomized, controlled clinical trials of lovastatin and gemfibrozil for heart disease prevention have reported statistically significantly lower melanoma incidences in persons receiving these medications. Results of in vitro animal model and human case–control studies also suggest that statins and fibrates may reduce the risk of melanoma. Methods: We performed a systematic review of trials that randomly assigned participants to receive statins or fibrates versus an alternative therapy for a minimum of 6 months. Trials were identified by searching five electronic databases and the reference lists of eligible publications. Unpublished data were solicited from trial investigators and pharmaceutical companies. A meta-analysis was performed using a fixed-effects model, and odds ratios (ORs) with 95% confidence intervals (CIs) were calculated to estimate pooled treatment effects. All statistical tests were two-sided. Results: We obtained data on incident melanomas from 20 of 36 qualifying randomized controlled trials (12 statin trials and eight fibrate trials), with a total of 70 820 participants. A total of 127 melanomas occurred among the 39 426 participants in the statin trials (59 among the 19 872 statin group participants and 68 among the 19 554 control group participants). A total of 27 melanomas occurred among the 31 394 participants enrolled in the fibrate trials (seven among the 12 324 fibrate group participants and 20 among the 19 070 control group participants). Overall, incidence of melanoma was not statistically significantly associated with the use of either statins (OR = 0.87, 95% CI = 0.61 to 1.23) or fibrates (OR = 0.45, 95% CI = 0.20 to 1.01). In a subgroup analysis by drug, only lovastatin use (in one trial) was statistically significantly associated with lower incidence of melanoma (OR = 0.52, 95% CI = 0.27 to 0.99). Conclusions: These findings do not validate the possibility that statins or fibrates prevent melanoma.