Evaluation of statin-induced muscle and liver adverse drug reactions in the Chinese population: a retrospective analysis of clinical trial data from 1992 to 2023.

Objectives: This study addressed the gaps in the disclosure of statin-associated adverse drug reactions (ADRs) in China's official database and the inadequacy of cases reported relative to the population size in public ADR databases.

Methods: To address these limitations, we conducted a retrospective trial-based analysis using data from Chinese journals to comprehensively assess statin-associated ADRs from 1992 to 2023, focusing on liver (2895 studies, n = 163 810) and muscle (2888 studies, n = 161 714) related outcomes.

Results: For large sample size clinical trial analysis (n≥100), our analysis encompassed data from 31 763 participants for muscle-related ADRs (incidence rate: 0.004-0.006, common effect model; 0.002-0.006, random effects model) and 31 281 participants for liver-related ADRs (incidence rate: 0.004-0.006, common effect model; 0.003-0.006, random effects model), covering various statins, including atorvastatin, simvastatin, rosuvastatin, fluvastatin, pitavastatin, pravastatin and lovastatin. Notably, muscle-related ADRs, particularly rhabdomyolysis, were most prevalent with fluvastatin, lovastatin and pravastatin, showing rates of 0.90%, 0.74% and 0.53%, respectively. Pitavastatin and atorvastatin were frequently associated with liver-related ADRs such as abnormal liver function and elevated enzymes, with rates of 5.36% and 1.819%, respectively.

Conclusions: This study underscores significant variations in ADR incidence among different statins in the Chinese population, providing critical insights for healthcare professionals and policymakers to enhance patient safety and optimise clinical decisions regarding statin therapy.