Treatment with icosapent ethyl (Vascepa; Amarin) was associated with significant regression of low attenuation plaque (LAP) volume on multidetector computed tomography (MDCT), according to findings presented at the annual meeting of the European Society of Cardiology (ESC) Congress 2020.
The randomized, double-blind, placebo-controlled phase 4 EVAPORATE study assessed the effects of icosapent ethyl, an ethyl ester of eicosapentaenoic acid, on the progression of coronary atherosclerosis in 80 adult patients with elevated triglycerides (200-499mg/dL) on statin therapy. Patients were enrolled if they had coronary atherosclerosis as documented by MDCT (≥1 angiographic stenoses with ≥20% narrowing), were on statin therapy, and had persistently elevated triglyceride levels. The prespecified primary end point was the change in LAP volume at 18 months.
Results demonstrated that icosapent ethyl significantly reduced LAP plaque volume by 17% from baseline to 18 months, whereas in the placebo arm, progression of LAP plaque volume was observed (P =.0061). The findings also showed that other plaque volumes (ie, fibrofatty and fibrous plaque volumes) regressed in the icosapent ethyl group and progressed in the placebo arm (P <.001 for all). No significant difference was observed between groups with regard to dense calcium (P =.053). Small sample size was considered the primary limitation of the study.
“EVAPORATE is the first demonstration of imaging results with icosapent ethyl using MDCT,” Matthew Budoff, MD, Director of Cardiovascular CT at The Lundquist Institute and Professor of Medicine at the David Geffen School of Medicine at UCLA. “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.”
Results from the REDUCE-IT study formed the basis of approval for Vascepa as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adults with elevated triglyceride (TG) levels (≥150mg/dL) and established cardiovascular disease (CVD), or diabetes plus ≥2 additional CVD risk factors. The product is also indicated as an adjunct to diet to reduce TG levels in adults with severe hypertriglyceridemia (≥500mg/dL).
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- Vascepa® (Icosapent Ethyl) reported to significantly reduce coronary plaque in EVAPORATE study final results presented at ESC Congress 2020. https://www.globenewswire.com/news-release/2020/08/29/2085755/0/en/VASCEPA-Icosapent-Ethyl-Reported-to-Significantly-Reduce-Coronary-Plaque-in-EVAPORATE-Study-Final-Results-Presented-at-ESC-Congress-2020.html. Accessed August 31, 2020.
- Budoff M, Bhatt DL, Kinninger A, et al. Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: final results of the EVAPORATE trial [published August 29, 2020]. European Heart Journal. doi: 10.1093/eurheartj/ehaa652.