An 80-subject Phase 4 clinical trial, EVAPORATE, evaluating Amarin’s (NASDAQ:AMRN) Vascepa (icosapent ethyl) in patients with elevated triglycerides (200 – 499 mg/dL) and coronary atherosclerosis on statin therapy met the primary endpoint demonstrating a statistically significant reduction in coronary plaque compared to placebo. The results were virtually presented at the European Society of Cardiology Annual Meeting.
Specifically, patients receiving Vascepa experienced a 17% regression of low attenuation plaque volume on multidetector computed tomography (MDCT) over 18 months compared to placebo.
Study sponsor Matthew Budoff, M.D., Director of Cardiovascular CT at The Lundquist Institute and Professor of Medicine at the David Geffen School of Medicine at UCLA, says, “EVAPORATE provides important mechanistic data on coronary plaque characteristics that are potentially relevant to the overall REDUCE-IT results and clinical use of icosapent ethyl. The REDUCE-IT REVASC analysis presented at American Society for Preventive Cardiology last month reported an early coronary revascularization benefit signal with sustained statistical significance attained by 11 months. EVAPORATE is the first demonstration of imaging results with icosapent ethyl using MDCT. The coronary plaque reduction shown in EVAPORATE is consistent with the benefits of icosapent ethyl in cardiovascular event outcomes shown in REDUCE-IT, a separate study.”
Amarin funded the study.
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