Hepatotoxicity of statins: a real-world study based on the US Food and Drug Administration Adverse Event Reporting System database
BackgroundStatins, 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...
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Frontiers Media S.A.
2025-01-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2024.1502791/full |
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| author | Bojing Wang Shu Huang Shu Huang Shiqi Li Yaqi Deng Ziyan Li Yizhou Wang Xiaomin Shi Wei Zhang Lei Shi Xiaohong Wang Xiaowei Tang |
| author_facet | Bojing Wang Shu Huang Shu Huang Shiqi Li Yaqi Deng Ziyan Li Yizhou Wang Xiaomin Shi Wei Zhang Lei Shi Xiaohong Wang Xiaowei Tang |
| author_sort | Bojing Wang |
| collection | DOAJ |
| description | BackgroundStatins, 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.MethodsIn 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.ResultsIn 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.ConclusionThis 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. |
| format | Article |
| id | doaj-art-10e32b9d769440f985f3f3d888781f46 |
| institution | Kabale University |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj-art-10e32b9d769440f985f3f3d888781f462025-01-07T06:51:16ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-01-011510.3389/fphar.2024.15027911502791Hepatotoxicity of statins: a real-world study based on the US Food and Drug Administration Adverse Event Reporting System databaseBojing Wang0Shu Huang1Shu Huang2Shiqi Li3Yaqi Deng4Ziyan Li5Yizhou Wang6Xiaomin Shi7Wei Zhang8Lei Shi9Xiaohong Wang10Xiaowei Tang11Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, ChinaDepartment of Gastroenterology, Lianshui County People’ Hospital, Huaian, ChinaDepartment of Gastroenterology, Lianshui People’ Hospital of Kangda College Affiliated to Nanjing Medical University, Huaian, ChinaDepartment of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, ChinaDepartment of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, ChinaDepartment of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, ChinaDepartment of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, ChinaDepartment of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, ChinaDepartment of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, ChinaDepartment of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, ChinaDepartment of Gastroenterology, Xuzhou Central Hospital, Xuzhou Clinical School of Xuzhou Medical University, Xuzhou, ChinaDepartment of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, ChinaBackgroundStatins, 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.MethodsIn 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.ResultsIn 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.ConclusionThis 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.https://www.frontiersin.org/articles/10.3389/fphar.2024.1502791/fullstatinsstatin drugsFAERShepatotoxicityhepatic disorderadverse event |
| spellingShingle | Bojing Wang Shu Huang Shu Huang Shiqi Li Yaqi Deng Ziyan Li Yizhou Wang Xiaomin Shi Wei Zhang Lei Shi Xiaohong Wang Xiaowei Tang Hepatotoxicity of statins: a real-world study based on the US Food and Drug Administration Adverse Event Reporting System database Frontiers in Pharmacology statins statin drugs FAERS hepatotoxicity hepatic disorder adverse event |
| title | Hepatotoxicity of statins: a real-world study based on the US Food and Drug Administration Adverse Event Reporting System database |
| title_full | Hepatotoxicity of statins: a real-world study based on the US Food and Drug Administration Adverse Event Reporting System database |
| title_fullStr | Hepatotoxicity of statins: a real-world study based on the US Food and Drug Administration Adverse Event Reporting System database |
| title_full_unstemmed | Hepatotoxicity of statins: a real-world study based on the US Food and Drug Administration Adverse Event Reporting System database |
| title_short | Hepatotoxicity of statins: a real-world study based on the US Food and Drug Administration Adverse Event Reporting System database |
| title_sort | hepatotoxicity of statins a real world study based on the us food and drug administration adverse event reporting system database |
| topic | statins statin drugs FAERS hepatotoxicity hepatic disorder adverse event |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2024.1502791/full |
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