Patients with Elevated Liver Enzymes Are Not at Higher Risk for Statin Hepatotoxicity

Naga Chalasani, Hisham Aljadhey, Joe Kesterson, Michael Murray, Stephen D. Hall

Research output: Contribution to journalArticle

303 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1287-1292
Number of pages6
JournalGastroenterology
Volume126
Issue number5
DOIs
StatePublished - May 2004

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Hydroxymethylglutaryl-CoA Reductase Inhibitors
Liver
Enzymes
Biochemistry
Transaminases
Incidence

ASJC Scopus subject areas

  • Gastroenterology

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Patients with Elevated Liver Enzymes Are Not at Higher Risk for Statin Hepatotoxicity. / Chalasani, Naga; Aljadhey, Hisham; Kesterson, Joe; Murray, Michael; Hall, Stephen D.

In: Gastroenterology, Vol. 126, No. 5, 05.2004, p. 1287-1292.

Research output: Contribution to journalArticle

Chalasani, Naga ; Aljadhey, Hisham ; Kesterson, Joe ; Murray, Michael ; Hall, Stephen D. / Patients with Elevated Liver Enzymes Are Not at Higher Risk for Statin Hepatotoxicity. In: Gastroenterology. 2004 ; Vol. 126, No. 5. pp. 1287-1292.
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title = "Patients with Elevated Liver Enzymes Are Not at Higher Risk for Statin Hepatotoxicity",
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.",
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N2 - 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.

AB - 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.

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