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KMID : 1011320100030020064
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Journal of Pharmacoepidemiology and Risk Management
2010 Volume.3 No. 2 p.64 ~ p.73
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Liver Injury Incidence and Risk after Statin Use
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Kim Yoon-I
Choi Nam-Kyong
Kim Yoon-Jun
Park Kyoung-Ho
Park Byung-Joo
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Abstract
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Objective: To investigate the characteristics, incidence rate, and risk factors affecting liver injury in patients with statin monotherapy.
Methods: We conducted a retrospective cohort study using hospital medical records. Patients aged 20-84 years old who newly treated with atorvastatin, lovastatin, simvastatin, or pravastatin in Seoul National University Hospital between January 2000 and December 2002 were included. Liver injury was classified by CIOMS criteria, liver transaminase elevation, and severe liver injury. Incidence was estimated using incidence density per 100 person-years and 95% confidence intervals (CIs). Adjusted hazard ratio (HR) of risk factors was estimated by using Cox’s proportion hazard model.
Results: A total of 1,535 patients were enrolled. Incidence of liver injury according to CIOMS criteria was 17.0; hepatocelluar injury 11.3, cholestatic injury 1.5, and mixed type liver injury 2.6, respectively. Incidence of liver transaminase elevation was 7.4, and incidence of severe liver injury was 3.5. Diabetes, hypertension (reverse direction), existing liver disease, concomitant use of contraindicated drugs, and hospitalization history were associated with liver injury. Lovastatin increased and pravastatin decreased the risk. In multivariate analysis, concomitant use of contraindicated drugs (HR: 5.31, 95% CI: 2.58-10.92), existing liver disease (HR: 2.41, 95% CI: 1.01-5.74), and hospitalization history (HR: 1.97, 95% CI: 1.48-2.63) were significant risk factors.
Conclusion: The incidence of liver injury in Korean stain users was relatively higher than that in western countries. Liver function should be monitored periodically and more carefully in the patients with high risk. Further studies to investigate accurate causal relationship and develop evidence-based clinical practice guideline will be needed.
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KEYWORD
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Statin, Liver injury, Incidence, Risk factor
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