Spontaneous Fluctuations in Liver Biochemistries in Patients with Compensated NASH Cirrhosis: Implications for Drug Hepatotoxicity Monitoring.

ABSTRACT:

Introduction

Patients with cirrhosis may have spontaneous fluctuations in liver enzymes, which may confound detection of drug-induced liver injury (DILI), but these fluctuations have not been described.

Objective

We sought to quantify spontaneous liver enzyme abnormalities in patients with cirrhosis due to nonalcoholic steatohepatitis (NASH) enrolled in clinical trials.

Methods

We examined the laboratory values of patients with compensated cirrhosis randomized to placebo in two clinical trials for NASH. Patients in one study were followed every 13 weeks up to week 57; patients in the other study were followed every 4 weeks up to week 120.

Results

In total, 53 and 85 patients were randomized to placebo in the trials. Baseline alanine aminotransferase (ALT) was g

SUBMITTER: Shamseddeen H 

PROVIDER: S-EPMC7050367 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature