Three-year outcomes under pemafibrate therapy in patients with metabolic dysfunction-associated steatotic liver disease: a long-term observational study.

AIM OF THE STUDY: Metabolic dysfunction-associated steatotic liver disease (MASLD) is a progressive disease that can cause cirrhosis and hepatocellular carcinoma. Although prevention strategies regarding MASLD progression are limited, pemafibrate, a selective peroxisome proliferator-activated receptor-α modulator, has emerged as a credible candidate for MASLD therapy. There are no available data regarding three-year outcomes for patients treated with pemafibrate. The aim of this study was to assess three-year outcomes under pemafibrate therapy in patients with MASLD.

MATERIAL AND METHODS: This is a retrospective study reviewing the medical records of patients with MASLD treated with pemafibrate 0.2 mg daily for three years. Patients with diabetes were excluded. Laboratory parameters and adverse events were evaluated.

RESULTS: Forty patients with MASLD received pemafibrate therapy for three years. Alanine aminotransferase (ALT), a representative marker of hepatic inflammation, decreased significantly after one year and remained approximately 50% lower for three years. Regarding lipid profiles, triglyceride level decreased significantly at six months and remained lower. Mac-2 binding protein glycosylation isomer (M2BPGi), a marker of hepatic fibrosis, decreased at six months and was maintained for three years, although its levels fluctuated slightly. At three years, reduction of M2BPGi levels was positively correlated with amelioration of hepatic inflammation but not lipid profiles. There were no adverse events.

CONCLUSIONS: Three-year outcomes of pemafibrate therapy are favorable in patients with MASLD. Long-term pemafibrate therapy has the potential to prevent progression of MASLD.