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CareNet Inc. and the Department of Public Health of the University of Occupational and Environmental Health, Japan are pleased to announce that the results of a joint study conducted by the two organizations with the aim of examining the clinical characteristics of patients with nonalcoholic steatohepatitis (NASH) and associated comorbidities have been published in the academic paper “Clinical characteristics in patients with nonalcoholic steatohepatitis in Japan” on 22 August 2023 in the BMJ.

This study is a Real World Data (RWD) study based on National Health Insurance and long-term elderly health insurance claims database with eligible patients diagnosed with NASH (receipt disease name and history of liver biopsy) in the five-year period between April 2015 and March 2020.

The key results included a comparison of patients who met the diagnostic definition for NASH (n = 545) with non-NASH controls (n = 185,264), which suggested a significantly higher BMI in NASH patients than in the controls. The results also indicated higher proportions of females and patients with dyslipidemia, hypertension, GERD, and Type 2 diabetes in the NASH group; in addition, NASH was associated with an increased risk of hepatic cirrhosis and liver cancer.

The paper concludes that in the daily medical care of patients with NASH, close attention needs to be paid to the risk of malignancies, including hepatic cirrhosis and liver cancer, as well as lifestyle comorbidities, considering sex and age differences.

About NASH

Nonalcoholic fatty liver disease (NAFLD) is the most common type of liver disease, affecting approximately 20–30% of the global population [1]. NAFLD includes nonalcoholic fatty liver (NAFL), which is pathologically pure steatosis alone or a situation in which steatosis is accompanied by inflammatory cell infiltration, and nonalcoholic steatohepatitis (NASH), which is accompanied by hepatic steatosis, inflammatory cell infiltration, ballooning (hepatocellular ballooning), and hepatic fibrosis [2].

NASH is strongly associated with metabolic syndrome, obesity, diabetes mellitus (DM), hypertension, and dyslipidemia [1], and the major causes of death are cardiovascular and liver-disease-related events [6]. However, the biopsy rate for NASH diagnosis is low, and NASH is underdiagnosed [6]. According to an estimate based on a Markov model of the number of patients with NAFL and NASH worldwide, the number of patients with fibrotic NASH at stage III or higher in Japan was predicted to increase to 660,000 in 2016 and 990,000 by 2030 [7]. Moreover, although NASH prevalence has been estimated at approximately 3–5% of the population [8,9], there is insufficient evidence regarding the NASH prevalence in the general population due to selection bias in liver biopsies and diagnostic difficulties.

About the paper

Title: Clinical characteristics in patients with nonalcoholic steatohepatitis in Japan: A case-control study using a 5-year large-scale claims database
Authors’ names: Kei Tokutsu, Kaoru Ito, Shigeki Kawazoe, Sota Minami, Kenji Fujimoto, Keiji Muramatsu, Shinya Matsuda
Journal: BMJ
DOI: 10.1136/bmjopen-2023-074851: external link

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