Crossover Trial of Pemafibrate and Omega-3-Acid Ethyl Esters for Hypertriglyceridemia in Patients with Cardiovascular Disease
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: Introduction: Statins can treat dyslipidemia, but even if low-density lipoprotein decreases to target levels, high triglyceride (TG) levels may represent a residual risk. Therefore, we performed a crossover study comparing pemafibrate and omega-3-acid ethyl esters docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) in patients with untreated hypertriglyceridemia. Methods: Patients were randomized by the envelope method to pemafibrate or DHA+EPA for 6 months and then switched to the other medication for 6 months. The primary endpoint was TG level, and secondary endpoints were lipid markers, fatty acid 4-fractionation, kidney and liver markers, and the Fibrosis-4 index. Results: In the 36 analyzed patients, pemafibrate showed a significantly greater decrease in TG (p < 0.001) and remnant-like particles cholesterol (p = 0.001) and a significantly greater increase in high-density lipoprotein (p < 0.001), but DHA+EPA showed a significantly greater improvement in fatty acid 4-fractionation (p < 0.001). Conclusions: When combined with a statin, pemafibrate appears to have a stronger effect in lowering TG and remnant-like particles cholesterol but DHA+EPA appears to be more effective in terms of fatty acids. Pemafibrate may be an effective first choice for hypertriglyceridemia, and add-on DHA+EPA may be beneficial when pemafibrate is not sufficiently effective. Findings need to be confirmed in larger studies.
Source: JMA Journal
Authors: Akira Sezai, Makoto Taoka, Hisakuni Sekino, Masashi Tanaka
Institution: Nihon University
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4417181230
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