Miyoshi Trou, Matsuzawa Yasushi, Doi Masayuki, Yuasa Shinsuke, Sugiyama Seigo
Cardiovascular Medicine, Okayama University, Okayama, JPN.
Cardiovascular Medicine, Kumamoto University, Kumamoto, JPN.
Cureus. 2025 Mar 24;17(3):e81104. doi: 10.7759/cureus.81104. eCollection 2025 Mar.
Despite intensive low-density lipoprotein cholesterol-lowering therapies effectively reducing cardiovascular events, residual cardiovascular risks remain significant, with hypertriglyceridemia being an important contributing factor. Pemafibrate, a novel selective peroxisome proliferator-activated receptor alpha modulator, has shown strong triglyceride-lowering effects and potential vascular benefits. Similarly, eicosapentaenoic acid ethyl ester (EPA) has demonstrated cardiovascular protective effects, particularly in patients with hypertriglyceridemia. However, the comparative impact of these agents on endothelial function, a key marker of atherosclerotic progression, has not been thoroughly evaluated in patients with coronary artery disease (CAD). The PRIME (PRospective comparIson of peMafibrate and Eicosapentaenoic acid ethyl ester on vascular functions for hypertriglyceridemia) trial is a multi-center, open-label, randomised trial designed to compare the effects of pemafibrate and EPA on endothelial function in patients with CAD and hypertriglyceridemia. Patients receiving statin therapy with fasting triglyceride levels ≥150 mg/dL will be randomised into two groups: pemafibrate (0.2 mg/day, with possible dose escalation to 0.4 mg/day) or EPA (1800 mg/day, with possible dose escalation to 2700 mg/day). Endothelial function will be assessed with reactive hyperemia index (RHI). The primary endpoint is the change in RHI at 12 weeks. The secondary endpoints include the changes in RHI at 24 weeks, correlations between changes in RHI and changes in lipid biomarkers, and changes in biochemical parameters at 12 and 24 weeks. This study investigates the comparative effects of pemafibrate and EPA on endothelial function, addressing an unmet need in managing residual cardiovascular risk in patients with CAD. The findings will contribute to the optimisation of treatment strategies in patients with CAD and hypertriglyceridemia.
尽管强化低密度脂蛋白胆固醇降低疗法能有效降低心血管事件，但残余心血管风险仍然很大，高甘油三酯血症是一个重要的促成因素。培马贝特是一种新型选择性过氧化物酶体增殖物激活受体α调节剂，已显示出强大的降甘油三酯作用和潜在的血管益处。同样，二十碳五烯酸乙酯（EPA）也已证明具有心血管保护作用，尤其是在高甘油三酯血症患者中。然而，在冠状动脉疾病（CAD）患者中，这些药物对内皮功能（动脉粥样硬化进展的关键标志物）的比较影响尚未得到充分评估。PRIME（培马贝特与二十碳五烯酸乙酯对高甘油三酯血症患者血管功能的前瞻性比较）试验是一项多中心、开放标签、随机试验，旨在比较培马贝特和EPA对CAD和高甘油三酯血症患者内皮功能的影响。接受他汀类药物治疗且空腹甘油三酯水平≥150mg/dL的患者将被随机分为两组：培马贝特（0.2mg/天，可能剂量增至0.4mg/天）或EPA（1800mg/天，可能剂量增至2700mg/天）。内皮功能将通过反应性充血指数（RHI）进行评估。主要终点是12周时RHI的变化。次要终点包括24周时RHI的变化、RHI变化与脂质生物标志物变化之间的相关性以及12周和24周时生化参数的变化。本研究调查了培马贝特和EPA对内皮功能的比较影响，解决了CAD患者残余心血管风险管理中未满足的需求。研究结果将有助于优化CAD和高甘油三酯血症患者的治疗策略。
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