Patients with elevated liver enzymes are not at higher risk for statin hepatotoxicity

Gastroenterology. 2004 May;126(5):1287-92. doi: 10.1053/j.gastro.2004.02.015.


Background & aims: Studies that evaluate the risk of hepatotoxicity from statins in hyperlipidemic subjects with elevated baseline serum transaminases are lacking. We conducted a study to test the hypothesis that patients with elevated baseline liver enzymes have higher risk of statin hepatotoxicity.

Methods: Our study consisted of the following 3 cohorts of patients seen between January 1, 1998 and June 31, 2002: Cohort 1: 342 hyperlipidemic patients with elevated baseline enzymes (AST >40 IU/L or ALT >35 IU/L) who were prescribed a statin; cohort 2: 1437 hyperlipidemic patients with normal transaminases who were prescribed a statin; and cohort 3: 2245 patients with elevated liver enzymes but who were not prescribed a statin. The effect of statins on liver biochemistries was assessed over a 6-month period after statins were prescribed. Elevations in liver biochemistries during follow-up were categorized into mild-moderate or severe based on predefined criteria.

Results: The incidence of mild-moderate elevations and severe elevations in liver biochemistries in cohort 1 were 4.7% and 0.6%, respectively. Compared with cohort 1, individuals in cohort 2 had lower incidence of mild-moderate elevations (1.9%, P = 0.002) but not severe elevations (0.2%, P = 0.2). However, between cohorts 1 and 3, there were no differences in the incidence of mild-moderate elevations (4.7% vs. 6.4%, respectively, P = 0.2) or severe elevations (0.6% vs. 0.4%, respectively, P = 0.6). Statin discontinuation during the follow-up was similar between cohorts 1 and 2 (11.1% vs. 10.7%, respectively, P = 0.8).

Conclusions: These data suggest that individuals with elevated baseline liver enzymes do not have higher risk for hepatotoxicity from statins.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Alanine Transaminase / blood*
  • Aspartate Aminotransferases / blood*
  • Case-Control Studies
  • Cohort Studies
  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / poisoning*
  • Hyperlipidemias / drug therapy
  • Liver / drug effects*
  • Liver / enzymology*
  • Male
  • Middle Aged
  • Risk Assessment


  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Aspartate Aminotransferases
  • Alanine Transaminase