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

• Published in: Pharmacoepidemiology and drug safety 2014-07, Vol.23 (7), p.719-725
• Main Authors: Chen, Guan-Lin, Hsiao, Fei-Yuan, Dong, Yaa-Hui, Shen, Li-Jiuan, Wu, Fe-Lin Lin
• Format: Article
• Language: English
• Subjects: Adult; Aged; Biological and medical sciences; Case-Control Studies; Case-control study; Chemical and Drug Induced Liver Injury - epidemiology; Chemical and Drug Induced Liver Injury - etiology; Clinical trial. Drug monitoring; Confidence intervals; Databases, Factual; Dose-Response Relationship, Drug; Drug toxicity and drugs side effects treatment; Female; Fluorobenzenes - administration & dosage; Fluorobenzenes - adverse effects; General pharmacology; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects; Liver; liver injury; Male; Medical sciences; Middle Aged; Multivariate Analysis; National Health Insurance Research Database (NHIRD); pharmacoepidemiology; Pharmacology. Drug treatments; Pyrimidines - administration & dosage; Pyrimidines - adverse effects; Regression Analysis; Risk; Rosuvastatin Calcium; statin; Statins; Sulfonamides - administration & dosage; Sulfonamides - adverse effects; Taiwan; Toxicity: digestive system; Young Adult
• ISSN: 1053-8569; 1099-1557
• DOI: 10.1002/pds.3646

ABSTRACT 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. Copyright © 2014 John Wiley & Sons, Ltd.