Clinical characteristics in patients with non-alcoholic steatohepatitis in Japan: a case-control study using a 5-year large-scale claims database

Kei Tokutsu; Kaoru Ito; Shigeki Kawazoe; Sota Minami; Kenji Fujimoto; Keiji Muramatsu; Shinya Matsuda

doi:10.1136/bmjopen-2023-074851

Clinical characteristics in patients with non-alcoholic steatohepatitis in Japan: a case-control study using a 5-year large-scale claims database

BMJ Open. 2023 Aug 22;13(8):e074851. doi: 10.1136/bmjopen-2023-074851.

Authors

Kei Tokutsu¹, Kaoru Ito^{2

3}, Shigeki Kawazoe^{1

4}, Sota Minami⁵, Kenji Fujimoto⁶, Keiji Muramatsu¹, Shinya Matsuda¹

Affiliations

¹ Department of Preventive Medicine and Community Health, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.
² Department of Preventive Medicine and Community Health, University of Occupational and Environmental Health Japan, Kitakyushu, Japan [email protected].
³ Life Science Business Unit, Renagence LLC, Morioka, Japan.
⁴ Medical Data Business Development Department, CareNet Inc, Chiyoda-ku, Japan.
⁵ Third Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.
⁶ Occupational Health Data Science Center, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.

Abstract

Objectives: To examine the clinical characteristics of patients with non-alcoholic steatohepatitis (NASH) and associated comorbidities.

Design: A case-control study using the national health insurance and the long-term elderly health insurance claims database.

Setting: Eligible patients diagnosed with NASH (ICD-10 K-75.8, other inflammatory liver disease or K-76.0, other fatty liver) between April 2015 and March 2020 were included.

Participants: Patients who met the diagnostic definitions for NASH (n=545) were matched with non-NASH controls (n=185 264) and randomly selected according to sex, birth year and residential area.

Interventions: No interventions were made.

Primary and secondary outcome measures: ORs were estimated for the relationship between patient background, such as age and sex, body mass index (BMI), NASH-related comorbidities and lifestyle-related diseases.

Results: In total, 545 patients with NASH (38.3% men) and 185 264 non-NASH controls (43.2% men) were identified, with median ages of 68 (IQR 63.0-75.0) and 65 (IQR 44.0-74.0) years, respectively. BMI was significantly higher in patients with NASH than in controls (25.8 kg/m² vs 22.9 kg/m², p<0.001). The proportions of women, patients with hypertension, patients with dyslipidaemia and patients with type 2 diabetes were higher in the NASH group. In addition, NASH was associated with an increased risk of hepatic cirrhosis (OR 28.81 (95% CI 21.79 to 38.08)), followed by liver cancer (OR 18.38 (95% CI 12.56 to 26.89)). There was no significant association between NASH and risk for depression (OR 1.11 (95% CI 0.87 to 1.41)), insomnia (OR 1.12 (95% CI 0.94 to 1.34)) or chronic kidney diseases (OR 0.81 (95% CI 0.58 to 1.12)).

Conclusions: In the daily medical care of patients, it is necessary to consider sex and age differences and to pay close attention to the risk of liver cancer, as well as other lifestyle-related comorbidities associated with NASH.

Keywords: Case-Control Studies; Hepatobiliary disease; PUBLIC HEALTH.

MeSH terms

Aged
Case-Control Studies
Diabetes Mellitus, Type 2*
Female
Humans
Japan / epidemiology
Liver Neoplasms*
Male
Middle Aged
Non-alcoholic Fatty Liver Disease* / complications
Non-alcoholic Fatty Liver Disease* / epidemiology