Gastroenterology

Gastroenterology

Volume 126, Issue 5, May 2004, Pages 1287-1292
Gastroenterology

Clinical-liver, pancreas, and biliary tract
Patients with elevated liver enzymes are not at higher risk for statin hepatotoxicity

https://doi.org/10.1053/j.gastro.2004.02.015Get rights and content

Abstract

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.

Section snippets

Patients

The Institutional Review Board at Indiana University School of Medicine has approved and administered this study in concordance with the principles of the Declaration of Helsinki. Data were collected from a large academic medical practice located in Indianapolis, which uses the Regenstrief Medical Record System (RMRS).14 This practice-based electronic record system captures patient information from 3 hospitals on the Indiana University Medical Center campus (Wishard Memorial Hospital, Indiana

Results

Cohort 1 contained 342 patients; cohort 2 contained 1437 patients; and cohort 3 contained 2245 patients. Demographics and selected characteristics of these 3 cohorts are shown in Table 1. Although there were some statistical differences in the demographics among the 3 groups, they did not appear to be clinically significant. Generally, all 3 cohorts consisted of a hyperlipidemic, middle-aged population with a female and white preponderance. Although the body weight, LDL, HDL, and creatinine

Discussion

To our knowledge, this is the first study to specifically address the question of whether patients with elevated baseline liver enzymes are at higher risk to develop hepatotoxicity from statins. In this study, we have addressed this question by comparing the changes in liver biochemistries of individuals with elevated liver enzymes and who were prescribed statins to controls. We found that patients with elevated baseline liver enzymes had higher incidence of mild-moderate but not severe

References (17)

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Supported in part by FDA (FD-T-001756 to S.D.H.) and NIH grants (UO-1 DK 065211 to N.C.).

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