20 Nov Mechanistic EVAPORATE Study Points to Lower Plaque Progression with Vascepa Treatment
MedicalResearch.com Interview with:
Matthew Budoff MD
Professor of Medicine, UCLA
Endowed Chair of Preventive Cardiology
Torrance, CA 90502
MedicalResearch.com: What is the background for this study?
Response: We present the nine-month interim analysis results from the EVAPORATE mechanistic study of Icosapent Ethyl, after benefits were seen with the REDUCE-IT Trial, demonstrating 25% event reduction. This trial was a serial multi-detector computed tomographic (MDCT) study to look at plaque progression between icosapent ethyl (4 gm/day) and matching placebo.
MedicalResearch.com: What are the main findings?
Response: The study demonstrated a 21% reduction in low attenuation plaque (a surrogate for vulnerable plaque or necrotic core). The secondary endpoints were also improved, with 42% reduction of progression of total plaque in the icosapent ethyl arm as compared to placebo (p=0.0004), reductions in non-calcified plaque (19%, p=0.01), fibrous plaque (57% slowing, p=0.11), calcific plaque (113% reduction, p=0.001), with a non-significant change in fibrofatty plaque (p=0.650).
MedicalResearch.com: What should readers take away from your report?
Response: Plaque progression has been established as an important predictor of cardiovascular events; therefore, therapies that can modulate this process represent an enticing potential option for mitigating CV risk. EVAPORATE randomized 80 patients with elevated triglycerides on statin therapy with atherosclerosis and at least one stenosis of 20% to Vascepa or placebo arms. Patients underwent baseline, nine month, and 18 month follow ups with CT angiograms to evaluate plaque. Results presented here are from a pre-specified nine month interim analysis.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: The primary endpoint did not hit the stopping parameter for the trial (needed a p value of <0.006), so the trial is continuing to the 18 month endpoint.
The study was an investigator sponsored multi-center, prospective, placebo-controlled randomized trial, sponsored by Amarin Pharma, and both drug and placebo were provided by sponsor.
Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients With Elevated Triglycerides on Statin Therapy – EVAPORATE
Abstract presented at: ACC 2019 Nov 18, 2019
Matthew J Budoff, Lundquist Inst and UCLA Sch of Med, Torrance, CA; Joseph Brent Muhlestein, Intermountain Heart Inst, Intermountain Medical Ctr, Salt Lake City, UT; Deepak L Bhatt, Brigham and Women’s Hosp, Boston, MA; Viet T Le, Heidi T May, Intermountain Heart Inst, Intermountain Medical Ctr, Salt Lake City, UT; Kashif Shaikh, Chandana Shekar, Lundquist Inst and UCLA Sch of Med, Torrance, CA; April Kinninger, LABIOMED, Torrance, CA; Suvasini Lakshmanan, Sion Roy, John Tayek, Lundquist Inst and UCLA Sch of Med, Torrance, CA; John R Nelson, California Cardiovascular Inst, Fresno, CA
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