Wang Bojing, Huang Shu, Li Shiqi, Deng Yaqi, Li Ziyan, Wang Yizhou, Shi Xiaomin, Zhang Wei, Shi Lei, Wang Xiaohong, Tang Xiaowei
Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, China.
Department of Gastroenterology, Lianshui County People' Hospital, Huaian, China.
Front Pharmacol. 2025 Jan 7;15:1502791. doi: 10.3389/fphar.2024.1502791. eCollection 2024.
Statins, as an important class of lipid-lowering drugs, play a key role in the prevention and treatment of cardiovascular diseases. However, with their widespread use in clinical practice, some adverse events have gradually emerged. In particular, the hepatotoxicity associated with statins use has become one of the clinical concerns that require sufficient attention.
In this study, we conducted a comprehensive and detailed analysis of the hepatotoxicity of statins based on the data of the US Food and Drug Administration Adverse Event Reporting System database from the first quarter (Q1) of 2004 to the Q1 of 2024 and used Reporting Odds Ratios and Empirical Bayes Geometric Mean to mine the signal of adverse events.
In this study, hepatic disorder related seven statins all exhibited positive signals. Through signal mining, we identified a total of 14,511 cases of adverse events associated with hepatic disorder caused by these statin drugs, with atorvastatin, simvastatin, and rosuvastatin occurring at a higher rate. A total of 148 positive signals related to adverse events of hepatic disorder were captured. Autoimmune hepatitis and drug-induced liver injury both presented positive signals across multiple statin drugs. Notably, atorvastatin had the most significant signal strength in cholestatic pruritus and bilirubin conjugation abnormal. Fluvastatin also showed notable signal strength in autoimmune hepatitis, while simvastatin had a relatively weaker signal strength for hepatic enzyme increased.
This study discovered specific adverse event signal values, revealing potential hepatotoxic risks associated with the use of statin drugs. The results provide an important reference for the safe clinical use of drugs, help to improve the understanding of the safety of statins, and also provide a scientific basis for clinicians to make more accurate and safe decisions when making treatment plans.
他汀类药物作为一类重要的降脂药物，在心血管疾病的预防和治疗中发挥着关键作用。然而，随着它们在临床实践中的广泛应用，一些不良事件逐渐出现。特别是，与他汀类药物使用相关的肝毒性已成为需要充分关注的临床问题之一。
在本研究中，我们基于美国食品药品监督管理局不良事件报告系统数据库2004年第一季度（Q1）至2024年Q1的数据，对他汀类药物的肝毒性进行了全面而详细的分析，并使用报告比值比和经验贝叶斯几何均值来挖掘不良事件信号。
在本研究中，与七种他汀类药物相关的肝脏疾病均呈现阳性信号。通过信号挖掘，我们共识别出由这些他汀类药物引起的与肝脏疾病相关的不良事件14511例，其中阿托伐他汀、辛伐他汀和瑞舒伐他汀的发生率较高。共捕获到148个与肝脏疾病不良事件相关的阳性信号。自身免疫性肝炎和药物性肝损伤在多种他汀类药物中均呈现阳性信号。值得注意的是，阿托伐他汀在胆汁淤积性瘙痒和胆红素结合异常方面的信号强度最为显著。氟伐他汀在自身免疫性肝炎方面也表现出显著的信号强度，而辛伐他汀在肝酶升高方面的信号强度相对较弱。
本研究发现了特定的不良事件信号值，揭示了与他汀类药物使用相关的潜在肝毒性风险。研究结果为药物的安全临床使用提供了重要参考，有助于提高对他汀类药物安全性的认识，也为临床医生在制定治疗方案时做出更准确、安全的决策提供了科学依据。
