| アブストラクト | BACKGROUND: Statin-associated autoimmune hepatitis (AIH) is a rare but potentially life-threatening adverse event. Currently, no studies have investigated the association between 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. |
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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2025/1/6 |
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| 投稿者 | Pan, Chen; Zhou, Xiaozhu; Wang, Yu; Wu, Yi; Han, Qiang; Cui, Xiangli |
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| 組織名 | Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University,;Beijing, China.;Department of Pharmacy, Capital Medical University, Beijing, China.;Liver Research Center, Beijing Friendship Hospital, Capital Medical University,;Clinical Laboratory, Beijing Friendship Hospital, Capital Medical University, |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39760480/ |
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