Abstract
PURPOSE: We aimed to evaluate the effects of statins on mood, sleep, and physical function. METHODS: We performed a systematic computer-aided search of MEDLINE/PubMed, EMBASE, and the Cochrane Central Register and augmented this search by scrutinizing reference lists and making inquiries among colleagues and experts in the field. All patient populations and study types were considered. We selected studies of statin therapy compared with no statin or placebo. Outcome measures included mood, sleep, and physical function. RESULTS: Thirty-four studies were included in qualitative synthesis. Seven of eight (88 %) observational studies, 4/6 (66 %) randomized trials with mood as a primary endpoint (487 total participants; exposure 4 weeks to 1 year), and 3/3 (100 %) randomized trials with mood as a secondary endpoint (2,851 total participants; exposure 1-4 years) were not compatible with a negative mood effect of statins. Comparatively, fewer studies examined statin effects on sleep and physical function. Studies reporting negative effects contained potential sources of bias, including multiple testing or lack of adjustment for confounders in observational studies, and failure to prespecify outcomes or report blinding in trials. CONCLUSIONS: A limited body of available evidence is most compatible with no adverse effect of statins on quality of life measures, namely, mood, sleep, and physical function. Studies suggesting such effects suffer from an increased risk of bias. High-quality, prospective, and adequately powered studies are needed, especially in the domains of sleep and physical function, with careful attention to patients who may be most vulnerable to adverse effects.