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Effects of Pemafibrate and Eicosapentaenoic Acid Ethyl Ester on Endothelial Function in Patients With
Trou Miyoshi1, Yasushi Matsuzawa2, Masayuki Doi3
1Cardiovascular Medicine, Okayama University, Okayama, JPN.
Insights
This study compares pemafibrate and eicosapentaenoic acid ethyl ester (EPA) for improving endothelial function in patients with coronary artery disease and hypertriglyceridemia. It assesses their impact on residual cardiovascular risk.
Area of Science:
- Cardiology
- Pharmacology
- Vascular Biology
Background:
- Residual cardiovascular risk persists despite statin therapy, with hypertriglyceridemia as a key contributor.
- Selective peroxisome proliferator-activated receptor alpha modulators like pemafibrate and eicosapentaenoic acid ethyl ester (EPA) show promise in managing hypertriglyceridemia and cardiovascular health.
- Endothelial dysfunction is a critical factor in atherosclerosis, yet comparative data on agents targeting hypertriglyceridemia is limited in coronary artery disease (CAD) patients.
Purpose of the Study:
- To compare the efficacy of pemafibrate versus EPA in improving endothelial function in patients with CAD and hypertriglyceridemia.
- To evaluate the impact of these treatments on residual cardiovascular risk markers.
- To provide evidence for optimizing treatment strategies in this high-risk population.
Main Methods:
- A multi-center, open-label, randomized trial (PRIME trial) was conducted.
- Patients with CAD and hypertriglyceridemia on statin therapy were randomized to receive pemafibrate or EPA.
- Endothelial function was assessed using the reactive hyperemia index (RHI) as the primary endpoint at 12 weeks.
Main Results:
- The study is designed to assess the primary endpoint of change in RHI at 12 weeks.
- Secondary endpoints include RHI changes at 24 weeks and correlations with lipid biomarkers and biochemical parameters.
- Results will elucidate the comparative effects of pemafibrate and EPA on vascular function.
Conclusions:
- This trial addresses a critical unmet need in managing residual cardiovascular risk in CAD patients with hypertriglyceridemia.
- Findings will inform clinical practice regarding the use of pemafibrate and EPA for improving endothelial function.
- The study aims to contribute to better therapeutic strategies for cardiovascular risk reduction.
Abstract:
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.
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