title: Patients with elevated liver enzymes are not at higher risk for statin hepatotoxicity.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Medicine, Indiana University School of Medicine, WD OPW 2005, 1001 West 10th Street, Indianapolis, IN 46202, USA. nchalasa@iupui.edu
authors.forename: Naga
authors.initials: N
authors.lastname: Chalasani
authors.forename: Hisham
authors.initials: H
authors.lastname: Aljadhey
authors.forename: Joe
authors.initials: J
authors.lastname: Kesterson
authors.forename: Michael D
authors.initials: MD
authors.lastname: Murray
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Hall
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood*; D001219:Aspartate Aminotransferases / Q000097:blood*; D016022:Case-Control Studies; D015331:Cohort Studies; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000506:poisoning*; D006949:Hyperlipidemias / Q000188:drug therapy; D008099:Liver / Q000187:drug effects* / Q000201:enzymology*; D008297:Male; D008875:Middle Aged; D018570:Risk Assessment
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase