Statin Use in Men and New Onset of Erectile Dysfunction: A Systematic Review and Meta-Analysis

BACKGROUND: Erectile dysfunction has been reported as an adverse effect of statin therapy. METHODS: We performed a meta-analysis of randomized trials and observational studies that compared statin users versus non-statin users and reported data regarding new onset of erectile dysfunction in men with established cardiovascular disease or cardiovascular disease risk factors. We used DerSimonian-Laird and Peto models to construct the summary estimates risk ratio. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) to assess the overall quality of evidence for new-onset erectile dysfunction. RESULTS: Three randomized trials and 3 observational studies were identified, with 69,448 men, of whom 24,661 were statin users. Statin use was not associated with an increased risk of new onset of erectile dysfunction by random effects model or fixed effect model (risk ratio 0.96; 95% confidence interval, 0.841.10; P = .58; and odds ratio 0.95; 95% confidence interval, 0.88-1.02; P = .20, respectively). This effect was similar in randomized trials and observational studies (P-interaction = .86). Randomized trials provided a moderate quality of evidence, and observational studies provided a very low quality of evidence by the GRADE assessment. Random effects meta-regression analyses revealed no difference in treatment effect according to age or diabetes mellitus (P = .83 and P = .74, respectively). CONCLUSIONS: Among men with established cardiovascular disease or cardiovascular disease risk factors, statin use does not seem to be associated with a new onset of erectile dysfunction. Adequately powered and high-quality randomized trials are recommended to confirm these findings. (C) 2018 Elsevier Inc. All rights reserved.