Examining the Nocebo Effect of Statins Through Statin Adverse Events Reported in the Food and Drug Administration Adverse Event Reporting System

Background: This study aimed to evaluate whether the high frequency of reported statin adverse effects (AEs) may be associated with nocebo effect. We compared nocebo-related subjective AEs objective and investigated factors potentially Methods: A retrospective cohort was conducted using Food Drug Administration Adverse Event Reporting System between January 2010 December 2019 for statins, including, atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin. Subjective included fatigue, muscular, nervous system AEs. Objective were defined as hepatic muscular number Mann-Whitney U test examined trends in versus reports over time linear regression interaction terms. evaluated association gender country regression. Quantitative detection signals estimated proportional reporting ratio odds Results: Of 2 994 487 overall AE reports, more than per quarter (mean±SD: 4777±1375.45 999±276.95; P <0.0001), during period ( <0.001). Women men (fatigue: 86.98 quarter, =0.035; AE: 417.95, <0.0001; 273.60, but fewer (−125.23 <0.0001). More United States relative other countries. Simvastatin-associated showed higher all statins (reporting ratio, 1.53 [95% CI, 1.49–1.58]). Conclusions: found that significantly are statins. AEs, related effect often by women men,