Patients with elevated liver enzymes are not at higher risk for statin hepatotoxicity.
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.
Chalasani
Naga
N
Department of Medicine, Indiana University School of Medicine, WD OPW 2005, 1001 West 10th Street, Indianapolis, IN 46202, USA. nchalasa@iupui.edu
Aljadhey
Hisham
H
Kesterson
Joe
J
Murray
Michael D
MD
Hall
Stephen D
SD
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
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase