Statins and the risk of liver injury: a population-based case-control study.
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.
Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.
Guan-Lin
GL
Chen
Fei-Yuan
FY
Hsiao
Yaa-Hui
YH
Dong
Li-Jiuan
LJ
Shen
Fe-Lin Lin
FL
Wu
D000328:Adult; D000368:Aged; D016022:Case-Control Studies; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology / Q000209:etiology*; D016208:Databases, Factual; D004305:Dose-Response Relationship, Drug; D005260:Female; D005464:Fluorobenzenes / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects*; D012044:Regression Analysis; D012306:Risk; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects*; D013624:Taiwan; D055815:Young Adult
D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium
Case-control study; National Health Insurance Research Database (NHIRD); liver injury; pharmacoepidemiology; statin