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Hepatotoxicity associated with statins: A retrospective pharmacovigilance study based on the FAERS database
1Department of Pharmacy, Chengdu Second People's Hospital, Chengdu, Sichuan, China.
Plos One
|July 9, 2025
Summary
Statins are linked to drug-induced liver injury (DILI). Fluvastatin, atorvastatin, and simvastatin show the highest DILI risk, particularly in older adults. This study assessed medication safety using real-world data.
Area of Science:
- Pharmacovigilance
- Hepatology
- Drug Safety
Background:
- Statins are widely prescribed cholesterol-lowering medications.
- Drug-induced liver injury (DILI) is a known risk associated with statin use.
- Real-world data is crucial for assessing the safety of commonly used medications like statins.
Purpose of the Study:
- To investigate the incidence and characteristics of statin-associated drug-induced liver injury (DILI).
- To assess the comparative risk of DILI among different statin medications using real-world data.
- To evaluate medication safety profiles of statins in a large patient population.
Main Methods:
- Utilized the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from 2004 to 2023.
- Extracted cases where statins were the primary suspected cause of DILI.
- Performed disproportionality analysis using reported odds ratios (ROR) and information component (IC) to identify significant associations.
Main Results:
- Identified 7779 cases of statin-associated DILI.
- Patients over 65 years old and females were more frequently affected.
- Flustatin, atorvastatin, and simvastatin exhibited the strongest DILI signals (ROR).
- Older patients (≥65 years) showed a stronger DILI signal for several statins.
- Simvastatin was associated with the highest mortality rate (12.15%).
Conclusions:
- Six statins are significantly associated with liver injury based on FAERS data.
- Flustatin, atorvastatin, and simvastatin pose the greatest risk for DILI.
- Findings highlight the importance of monitoring liver function during statin therapy, especially in elderly patients.
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