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Published online: 2021-08-02
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Elevated serum transaminases in patients with acute coronary syndromes: Do we need a revision of exclusion criteria for clinical trials?

Małgorzata Jasiewicz, Michał Siedlaczek, Michał Kasprzak, Diana A. Gorog, Bernd Jilma, Jolanta Siller-Matula, Karolina Obońska, Ryszard Dobosiewicz, Krzysztof Pstrągowski, Jacek Kubica
DOI: 10.5603/CJ.a2021.0081
·
Pubmed: 34355781

open access

Ahead of print
Original articles
Published online: 2021-08-02

Abstract

Background: Elevations of hepatic transaminase (serum alanine transaminase [ALT] and serum aspartate aminotransferase [AST]) levels in patients with acute coronary syndrome (ACS), although transient, may result in exclusions from clinical efficacy trials due to suspected liver disease. The aim of this study was to evaluate the concentrations of serum transaminases in ACS and relate these to currently accepted AST/ALT exclusion criteria from clinical trials.

Methods: 100 consecutive patients with ACS were prospectively examined. Blood samples for AST, ALT, total bilirubin and troponin I concentration were obtained at the time of admission and after 6, 12 and 24 hours.

Results: Eighty percent of patients had elevated AST, and 47% ALT; 43% of patients characterized AST concentration > 3 × upper limit of normal (ULN) in at least one measurement, while 8% of patients presented ALT concentration > 3 × ULN. AST presented higher concentrations when compared to ALT, resulting in a high De-Ritis ratio at every time point. No significant or high correlations were found between the concentrations of serum transaminases, De-Ritis ratio and troponin I. Two different cut-off values of troponin I were adopted to define the amount of infarcted myocardium that distinguished 28–31% of individuals with “large infarction”. Among these patients, approximately 93% presented AST concentrations > 3 × ULN.

Conclusions: Hepatic transaminases are often elevated in ACS, with the majority of patients with more extensive myocardial injury presenting high concentrations of AST. In the setting of ACS, current transaminase thresholds for liver dysfunction used in clinical trials may lead to excessive and inadequate exclusions of patients with larger infarcts from such trials.

Abstract

Background: Elevations of hepatic transaminase (serum alanine transaminase [ALT] and serum aspartate aminotransferase [AST]) levels in patients with acute coronary syndrome (ACS), although transient, may result in exclusions from clinical efficacy trials due to suspected liver disease. The aim of this study was to evaluate the concentrations of serum transaminases in ACS and relate these to currently accepted AST/ALT exclusion criteria from clinical trials.

Methods: 100 consecutive patients with ACS were prospectively examined. Blood samples for AST, ALT, total bilirubin and troponin I concentration were obtained at the time of admission and after 6, 12 and 24 hours.

Results: Eighty percent of patients had elevated AST, and 47% ALT; 43% of patients characterized AST concentration > 3 × upper limit of normal (ULN) in at least one measurement, while 8% of patients presented ALT concentration > 3 × ULN. AST presented higher concentrations when compared to ALT, resulting in a high De-Ritis ratio at every time point. No significant or high correlations were found between the concentrations of serum transaminases, De-Ritis ratio and troponin I. Two different cut-off values of troponin I were adopted to define the amount of infarcted myocardium that distinguished 28–31% of individuals with “large infarction”. Among these patients, approximately 93% presented AST concentrations > 3 × ULN.

Conclusions: Hepatic transaminases are often elevated in ACS, with the majority of patients with more extensive myocardial injury presenting high concentrations of AST. In the setting of ACS, current transaminase thresholds for liver dysfunction used in clinical trials may lead to excessive and inadequate exclusions of patients with larger infarcts from such trials.

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Keywords

serum alanine transaminase, serum aspartate aminotransferase, acute coronary syndrome, clinical trial, exclusion criteria

About this article
Title

Elevated serum transaminases in patients with acute coronary syndromes: Do we need a revision of exclusion criteria for clinical trials?

Journal

Cardiology Journal

Issue

Ahead of print

Article type

Original Article

Published online

2021-08-02

DOI

10.5603/CJ.a2021.0081

Pubmed

34355781

Keywords

serum alanine transaminase
serum aspartate aminotransferase
acute coronary syndrome
clinical trial
exclusion criteria

Authors

Małgorzata Jasiewicz
Michał Siedlaczek
Michał Kasprzak
Diana A. Gorog
Bernd Jilma
Jolanta Siller-Matula
Karolina Obońska
Ryszard Dobosiewicz
Krzysztof Pstrągowski
Jacek Kubica

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