Pemafibrate improves hepatic inflammation, function and fibrosis in patients with non-alcoholic fatty liver disease: a one-year observational study

AIM OF THE STUDY: To optimize the long-term outcomes of patients with non-alcoholic fatty liver disease (NAFLD), long-term therapy is important to prevent cirrhosis and hepatocellular carcinoma. Pemafibrate, a novel selective peroxisome proliferator-activated receptor-α modulator, is a promising therapeutic agent for patients with NAFLD. However, only short-term clinical studies are currently available. The aim of this study is to evaluate the long-term outcomes of patients with NAFLD treated with pemafibrate. MATERIAL AND METHODS: This is a retrospective observational study. Patients with NAFLD treated with pemafibrate 0.1 mg twice daily for one year were retrospectively reviewed. RESULTS: Twenty-two patients without diabetes mellitus were included and analyzed. Regarding hepatic inflammation markers, alanine aminotransferase (ALT) significantly decreased during the first three months and was maintained. Low-density lipoprotein and triglycerides significantly decreased at three months and were maintained. Regarding markers of hepatic function, the albumin-bilirubin score decreased significantly during one year of therapy due to significantly elevated serum albumin and decreased total bilirubin levels. Regarding markers of fibrosis, Mac-2 binding protein glucosylation isomer (M2BPGi) significantly decreased, and platelet count increased significantly. Next, we performed correlation analysis between changes in M2BPGi and other parameters. Changes in aspartate aminotransferase, ALT and triglycerides positively correlated with the change in M2BPGi. CONCLUSIONS: One-year pemafibrate therapy improves markers of hepatic inflammation, function and fibrosis in non-diabetic patients with NAFLD. Improvement of hepatic fibrosis markers significantly correlates with improvement of hepatic inflammation markers and triglyceride levels.