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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Gastrointestinal and Hepatic Pharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1502791

Hepatotoxicity of statins: a real-world study based on the US Food and Drug Administration Adverse Event Reporting System database

Provisionally accepted
Bojing Wang Bojing Wang 1*Shu Huang Shu Huang 2*Shiqi Li Shiqi Li 1*Yaqi Deng Yaqi Deng 1*Ziyan Li Ziyan Li 1*Yizhou Wang Yizhou Wang 1*Xiaomin Shi Xiaomin Shi 1*Wei Zhang Wei Zhang 1*Lei Shi Lei Shi 1*Xiaohong Wang Xiaohong Wang 3*Xiaowei Tang Xiaowei Tang 1*
  • 1 The Affiliated Hospital of Southwest Medical University, Luzhou, China
  • 2 Lianshui County People’s Hospital, Huai’an, China
  • 3 Xuzhou Central Hospital, Xuzhou, Jiangsu Province, China

The final, formatted version of the article will be published soon.

    Background: 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. Methods: 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. Results: In this study, hepatic disorder related seven statins all exhibited positive signals. Through signal mining, we identified a total of 14511 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.

    Keywords: Statins, Statin drugs, FAERS, Hepatotoxicity, Hepatic disorder, Adverse event

    Received: 27 Sep 2024; Accepted: 13 Dec 2024.

    Copyright: © 2024 Wang, Huang, Li, Deng, Li, Wang, Shi, Zhang, Shi, Wang and Tang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Bojing Wang, The Affiliated Hospital of Southwest Medical University, Luzhou, China
    Shu Huang, Lianshui County People’s Hospital, Huai’an, China
    Shiqi Li, The Affiliated Hospital of Southwest Medical University, Luzhou, China
    Yaqi Deng, The Affiliated Hospital of Southwest Medical University, Luzhou, China
    Ziyan Li, The Affiliated Hospital of Southwest Medical University, Luzhou, China
    Yizhou Wang, The Affiliated Hospital of Southwest Medical University, Luzhou, China
    Xiaomin Shi, The Affiliated Hospital of Southwest Medical University, Luzhou, China
    Wei Zhang, The Affiliated Hospital of Southwest Medical University, Luzhou, China
    Lei Shi, The Affiliated Hospital of Southwest Medical University, Luzhou, China
    Xiaohong Wang, Xuzhou Central Hospital, Xuzhou, 221000, Jiangsu Province, China
    Xiaowei Tang, The Affiliated Hospital of Southwest Medical University, Luzhou, China

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