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Clinical Outcomes in Biopsy-Proven Nonalcoholic Fatty Liver Disease Patients: A Multicenter Registry-Based Cohort Study

H. Fujii, Michihiro Iwaki, H. Hayashi, H. Toyoda, Satoshi Oeda, H. Hyogo, M. Kawanaka, A. Morishita et al.

Clinical Gastroenterology and Hepatology, 2022

1,398 participants · 79 citations

Abstract

BACKGROUND AND AIMS

There are no detailed reports of clinical outcomes in Asian patients with nonalcoholic fatty liver disease (NAFLD) who undergo liver biopsy. We aimed to investigate the clinical outcomes of a large cohort of Asian patients with biopsy-proven NAFLD and evaluate the specific effects of nonalcoholic steatohepatitis (NASH) and fibrosis stage.

METHODS

This multicenter registry-based retrospective cohort study, called the CLIONE-NAFLD (clinical outcome nonalcoholic fatty liver disease) in Asia, included 1398 patients.

RESULTS

The median follow-up period was 4.6 years (range, 0.3-21.6), representing a total of 8,874 person-years of follow-up. During that time, 47 patients died and one patient underwent orthotopic liver transplantation. The leading cause of death was nonhepatic cancer (n=10). The leading causes of liver-related death were liver failure (n=9), hepatocellular carcinoma (HCC) (n=8), and cholangiocellular carcinoma (n=4). During follow-up, 37 patients developed HCC, 31 developed cardiovascular disease, and 68 developed nonhepatic cancer (mainly breast, stomach, and colon/rectum). Among our cohort of patients with NAFLD, liver-specific mortality was 2.34/1,000 person-years (95% confidence interval [CI] 1.52-3.58), overall mortality was 5.34/1,000 person-years (95% CI 4.02-7.08), and HCC incidence was 4.17/1,000 person-years (95% CI 3.02-5.75). Liver fibrosis was independently associated with liver-related events but not overall mortality.

CONCLUSION…

How strong is the evidence?

Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 1,398 participants or records.

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