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Severe hepatic injury associated with different statins in patients with chronic liver disease: a nationwide population-based cohort study.

Journal of gastroenterology and hepatology (2014-07-22)
Chia-Hsuin Chang, Yi-Cheng Chang, Yen-Chieh Lee, Ying-Chun Liu, Lee-Ming Chuang, Jou-Wei Lin
ABSTRACT

The hepatotoxicity of statins in patients with chronic liver diseases remains unclear. In this study, we aimed to estimate the risk of severe hepatic injury associated with different statins in patients with chronic liver disease. A nationwide population-based cohort study was conducted by analyzing the Taiwan National Health Insurance database. A total of 37,929 subjects with chronic liver disease who started statin therapy were identified during the period of January 1, 2005 to December 31, 2009. Outcome was defined as hospitalization due to liver injury. During a total of 118,772 person-years of follow-up, 912 incident cases of hospitalization due to hepatic injury are identified. The incidence rate was 2.95, 2.49, 2.92, 1.94, 2.65, and 2.52 per 100,000 person-days for atorvastatin, lovastatin, fluvastatin, pravastatin, simvastatin, and rosuvastatin initiators, respectively. Overall, there was no difference in the incidence associated with different statins. However, when each statin was further categorized to high (≧ 0.5 defined daily dose) or low (< 0.5 defined daily dose) mean daily dose, only high-dose atorvastatin was significantly associated with increased risk of hospitalization due to hepatic injury (hazard ratio, 1.62; 95% confidence interval, 1.29, 2.03) as compared with low-dose atorvastatin. The overall incidence of hospitalization due to severe hepatic injury was low among statin initiators with chronic liver disease. Only high-dose atorvastatin was associated with increased risk.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Simvastatin, ≥97% (HPLC), solid
Supelco
Simvastatin, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Simvastatin, analytical standard
USP
Simvastatin, United States Pharmacopeia (USP) Reference Standard
Simvastatin, European Pharmacopoeia (EP) Reference Standard