Autoimmune hepatitis associated with statins: a retrospective study of pharmacovigilance databases and review of the literature.

Background: Statin-associated autoimmune hepatitis (AIH) is a rare but potentially life-threatening adverse event. Currently, no studies have investigated the associationbetween AIH and different statins.

Research design and methods: This retrospective analysis of statin-associated AIH utilized the FDA Adverse Event Reporting System (FAERS) database (Q1 2004 to Q1 2024) and a systematic literature review. Disproportionality and Bayesian analyses were used to detect potential AIH signals associated with statin use.

Results: Among 3,581 AIH reports in the FAERS database, 337 (9.41%) were associated with statins. Among all statins, fluvastatin exhibited the strongest signal, with a relative odds ratio (ROR) of 54.85 (95% CI: 32.32-93.10). Stratified analysis revealed stronger signals in patients ≥65 years (ROR 16.83 vs 9.45) and females (ROR 13.88 vs 9.00) compared to patients <65 years and males, respectively. Statins showed a higher risk of AIH compared to evolocumab, and a similar or lower risk when compared to ezetimibe and fenofibrate. Additionally, 30 cases reported in 20 independent studies were summarized.

Conclusion: This study demonstrates a significant association between AIH and the use of statins, particularly among older patients and females. Further research is needed to explore additional risk factors for statin-associated AIH.