Statins and the risk of liver injury: a population-based case-control study

Pharmacoepidemiol Drug Saf. 2014 Jul;23(7):719-25. doi: 10.1002/pds.3646. Epub 2014 May 14.


Objective: This case-control study investigated the association between statin use and liver injury using Taiwan's National Health Insurance Research Database.

Methods: Our study subjects included 4165 cases (patients who had been admitted with a primary diagnosis of liver injury between 2002 and 2009) and 16 660 age-matched, sex-matched and index date-matched controls. Multivariable conditional regression models were used to estimate the association between statin use and liver injury.

Results: Users of statins were not associated with risk of liver injury (adjusted odds ratio [aOR] 1.04; 95% confidence interval [0.90-1.19]) when compared with nonusers. Nevertheless, a higher dose of statin (≥1 defined daily dose; aOR 1.55 [1.14-2.11]) and use of rosuvastatin before event of liver injury (aOR 1.38 [1.03-1.85]) were significantly associated with liver injury.

Conclusions: This population-based study extends previous evidence by exploring the potential association between statins use and risk of liver injury. Overall, we found that statin was not associated with risk of liver injury. Nevertheless, special concern should be paid to those who used statin ≥1 defined daily dose and rosuvastatin.

Keywords: Case-control study; National Health Insurance Research Database (NHIRD); liver injury; pharmacoepidemiology; statin.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Case-Control Studies
  • Chemical and Drug Induced Liver Injury / epidemiology
  • Chemical and Drug Induced Liver Injury / etiology*
  • Databases, Factual
  • Dose-Response Relationship, Drug
  • Female
  • Fluorobenzenes / administration & dosage
  • Fluorobenzenes / adverse effects*
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects*
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Pyrimidines / administration & dosage
  • Pyrimidines / adverse effects*
  • Regression Analysis
  • Risk
  • Rosuvastatin Calcium
  • Sulfonamides / administration & dosage
  • Sulfonamides / adverse effects*
  • Taiwan
  • Young Adult


  • Fluorobenzenes
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Pyrimidines
  • Sulfonamides
  • Rosuvastatin Calcium