Real-World Effects of Pemafibrate Extended-Release in Patients with Hypertriglyceridemia: A 12-Month Retrospective Study
Abstract
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.
Related
- Dose-dependent efficacy and renal safety of pemafibrate versus fenofibrate in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and hypertriglyceridemia: a multicenter randomized controlled, open label trial
- Histological and molecular responses to pemafibrate in MASLD with hypertriglyceridemia: the CLARITY study
- Reduction in Rheumatoid Factor and Matrix Metalloproteinase-3 With Successful Glucocorticoid Withdrawal After Initiation of Pemafibrate in a Patient With Rheumatoid Arthritis and Hypertriglyceridemia: A Case Report.
- Extended-release guanfacine overdose in a pediatric emergency department: a systematic review and a 10-year retrospective chart review
- Impact of hypertriglyceridemia on right ventricular deformation in patients with left ventricular myocardial infarction: a cardiac magnetic resonance imaging study
BibTeX
@article{inoue2026realworld,
title = {{Real-World Effects of Pemafibrate Extended-Release in Patients with Hypertriglyceridemia: A 12-Month Retrospective Study}},
author = {Saori Inoue and Takashi Kamiya and Syusaku Kanemori and Reiichiro Fujita and Aya Morita and Hiroko Yasuda},
journal = {Internal Medicine},
year = {2026},
month = sep,
doi = {10.2169/internalmedicine.8208-26},
url = {https://www.jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_8208-26/_article},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Real-World Effects of Pemafibrate Extended-Release in Patients with Hypertriglyceridemia: A 12-Month Retrospective Study
AU - Saori Inoue
AU - Takashi Kamiya
AU - Syusaku Kanemori
AU - Reiichiro Fujita
AU - Aya Morita
AU - Hiroko Yasuda
PY - 2026
DA - 2026/09/29
JO - Internal Medicine
DO - 10.2169/internalmedicine.8208-26
UR - https://www.jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_8208-26/_article
AB - 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.
SN - 1349-7235
SN - 0918-2918
ER -