Evaluation of the beneficial effects of pemafibrate in hypertriglyceridemia with or without alcohol drinking (PAR-CHAT: PARmodia-CHikushi Anti-dyslipidemia Trial)

To examine the efficacy and safety of pemafibrate in outpatients with hypertriglyceridemia, including alcoholic hypertriglyceridemia. This multicenter, open-label, prospective observational study (C20-07-009) included outpatients with hypertriglyceridemia being treated with pemafibrate who were registered at Fukuoka University Chikushi Hospital or associated clinics. Endpoints were changes in serum triglyceride (TG) and high-density lipoprotein cholesterol (HDL-C), hepatic biomarkers, and other blood values from baseline to 24 weeks and safety. Patients were compared according to alcohol drinking. From October 2020 to March 2022, 203 patients were registered at 14 facilities. We analyzed 174 patients (mean age, 65.5 years) with baseline fasting TG values who continued pemafibrate for 24 weeks; 55 % drank alcohol, and 35 % were receiving statins. Median fasting TG was 284 mg/dL (IQR, 228–392 mg/dL) at baseline and decreased significantly to 141 mg/dL (IQR, 108–194 mg/dL) at 24 weeks (p < 0.01), independent of alcohol use (non-drinking group, 259 to 134 mg/dL; daily drinking group, 318 to 169 mg/dL; occasional drinking group, 298 to 158 mg/dL; all p < 0.01). Median HDL-C increased significantly from 46 mg/dL (IQR, 39–53 mg/dL) at baseline to 53 mg/dL (IQR, 45–60 mg/dL) at 24 weeks (p < 0.01). Hepatic biomarkers improved significantly at 24 weeks. Low-density lipoprotein cholesterol (LDL-C) increased significantly overall, but not in patients receiving statins. Side effects throughout the study period included dizziness and nausea (1 patient each). Pemafibrate improves TG, HDL-C, hepatic biomarkers and hypertriglyceridemia regardless of alcohol consumption and is safe. Increase of LDL-C was suppressed in patients treated with statins. • We evaluated the efficacy and safety of pemafibrate in hypertriglyceridemia with or without alcohol drinking in a multi-center prospective real world clinical study. • We evaluated the efficacy and safety of pemafibrate in patients with hypertriglyceridemia with or without alcohol drinking in a multi-center prospective real world clinical study. • Pemafibrate improved hypertriglyceridemia and liver function regardless of alcohol drinking. • Pemafibrate combined with statin therapy was safe and suppressed the increased LDL-C due to Pemafibrate treatment.