Real-World Effects of Pemafibrate Extended-Release in Patients with Hypertriglyceridemia: A 12-Month Retrospective...

Pemafibrate extended-release (XR), a once-daily formulation of pemafibrate, was developed to improve treatment convenience. However, real-world evidence regarding its long-term effectiveness, particularly after switching from conventional twice-daily pemafibrate, is limited. This study evaluated the efficacy and safety of pemafibrate XR in patients with hypertriglyceridemia.

This retrospective observational study included 115 patients treated with pemafibrate XR for 12 months. Changes in the lipid profiles, liver-related biochemical parameters, and metabolic parameters were evaluated. A subgroup analysis was performed in patients who switched from conventional twice-daily pemafibrate to pemafibrate XR.

The triglyceride levels significantly decreased from 226 [142.5-368] mg/dL at baseline to 148 [112-203.5] mg/dL at 12 months (p<0.001). The high-density lipoprotein cholesterol levels significantly increased, whereas the low-density lipoprotein cholesterol levels remained unchanged. Liver-related parameters, including alanine aminotransferase, γ-glutamyl transpeptidase, and alkaline phosphatase, significantly improved, whereas the Fibrosis-4 index did not. The serum albumin levels increased, whereas the uric acid levels decreased after treatment. In the switch subgroup (n=75), the triglyceride and alanine aminotransferase levels significantly improved after the switch.

Pemafibrate XR was associated with improvements in the triglyceride levels and liver-related biochemical parameters in real-world clinical practice. Among patients switched from twice-daily pemafibrate, favorable lipid and liver-related biochemical parameters were maintained during treatment with pemafibrate XR.