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

OBJECTIVE

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.

PATIENTS OR MATERIALS: 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.

RESULTS

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.

CONCLUSION

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.