Abstract
BACKGROUND: Statins are commonly prescribed in clinical practice and are associated with a high risk of drug-induced liver injury (DILI). This study aims to examine the real-world data on statin-induced liver injury to assess medication safety. METHODS: All DILI cases reported with statins as primary suspected drugs were extracted based on the US Food and Drug Administration adverse event reporting system (FAERS) from 2004 to 2023. A disproportional analysis was conducted using reported odds ratios (ROR) and information component (IC) to assess the significant association between statins and DILI. RESULTS: A total of 7779 statin-associated DILI cases were identified. DILI patients tended to be aged >65 years (45.43%), with more females than males (48.80% vs 43.75%), and 39.95% of DILI patients required hospitalization. Statin-induced DILI cases are most commonly reported with atorvastatin (53.48%), rosuvastatin (20.44%), and simvastatin (19.46%). The DILI signals (ROR; 95% CI) for statins were ranked as follows: fluvastatin (6.90; 5.89-8.10)> atorvastatin (3.09; 2.99-3.19)> simvastatin (2.96; 2.81-3.12)> lovastatin (2.77; 2.17-3.53)> rosuvastatin (2.27; 2.16-2.39)> pravastatin (2.07; 1.81-2.37). Age-stratified analysis showed that a stronger signal was detected in patients (aged ≥65 years) than patients (aged <65 years) for atorvastatin, simvastatin, pravastatin and fluvastatin. The onset time of DILI was significantly different among the different statins (p = 0.014), and simvastatin resulted in the highest mortality rate (12.15%). CONCLUSION: Based on FAERS database, six statins are significantly associated with liver injury, and fluvastatin, atorvastatin, and simvastatin had the greatest risk of DILI.