Statin-induced liver injury in an area endemic for hepatitis B virus infection: risk factors and outcome analysis

Br J Clin Pharmacol. 2016 Sep;82(3):823-30. doi: 10.1111/bcp.13009. Epub 2016 Jun 17.


Aims: Statin-induced liver injury (SILI) is quite rare, but may be severe. Little is known about the impact of chronic hepatitis B infection (CHBI) on SILI. We aimed to investigate the risk factors and outcome of SILI, with special reference to its interaction with CHBI.

Methods: Patients with SILI were recruited from our hospital, and three-to-one drug-matched controls were randomly selected. The clinical data of the patients were then compared.

Results: A total of 108 patients with SILI and 324 controls were enrolled. The patients with SILI were both older and had a higher statin dose than the controls. There was no predilection of liver injury associated with the seven available statins. Among the SILI patients, there was no statistical difference between the baseline and peak liver enzyme tests, and latency and severity between hepatitis B carriers (n = 16) and non-carriers (n = 92). High dose of statin and age were the two independent risk factors of SILI (OR and 95% CI: 1.93, 1.08-3.35, P = 0.025, and 1.73, 1.07-2.80, P = 0.027, respectively). Permanent discontinuation of statin was noted in 50 (46.3%) patients with SILI due to severe SILI or recurrent hepatotoxicity after rechallenge of other statins.

Conclusion: High dose of statin and old age may increase patient susceptibility to SILI; however, CHBI and abnormal baseline liver tests are not risk factors of SILI. Nonetheless, SILI is still worthy of notice, because nearly half of the overt cases discontinued statin treatment due to severe hepatotoxicity in this study.

Keywords: drug safety; drug-induced liver injury; hepatitis B; hydroxymethylglutaryl CoA reductase inhibitors; statin.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Age Factors
  • Aged
  • Case-Control Studies
  • Chemical and Drug Induced Liver Injury / epidemiology*
  • Female
  • Hepatitis B / epidemiology*
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects*
  • Liver Function Tests
  • Male
  • Middle Aged
  • Risk Factors
  • Taiwan / epidemiology


  • Hydroxymethylglutaryl-CoA Reductase Inhibitors