Results from EVAPORATE trial of Vascepa in coronary atherosclerosis published in European Heart Journal.- HLS Therapeutics

HLS Therapeutics announced that final results with Vascepa (icosapent ethyl) in patients with coronary atherosclerosis, from the EVAPORATE Trial were presented at ESC Congress 2020. Vascepa demonstrated significant, 17% regression of low attenuation plaque (LAP) volume on multidetector computed tomography (MDCT) compared with placebo over 18 months. These final results can be found in the concurrent publication in European Heart Journal. A total of 80 patients were enrolled in the randomized, double-blind, placebo-controlled EVAPORATE trial. Patients had to have coronary atherosclerosis as documented by MDCT (1 or more angiographic stenoses with at least 20% narrowing), be on statin therapy, and have persistently elevated triglyceride (TG) levels (mean TG at baseline was 259.1 mg/dL [+/- 78.1], (2.93 mmol/L [+/-0.88]). Patients underwent an interim scan at 9 months and a final scan at 18 months. The prespecified primary endpoint was a comparison of change in LAP volume at 18 months between icosapent ethyl and placebo. EVAPORATE was not powered for long-term outcomes. The final results showed a significant reduction in the primary endpoint; icosapent ethyl reduced LAP plaque volume by 17% from baseline to the 18-month scan, whereas there was a progression of LAP plaque volume in the placebo group. There were significant differences between icosapent ethyl and placebo at study end for secondary endpoints of other types of plaque volume changes, including sequentially total, total non-calcified, fibrofatty, and fibrous plaque volumes. All regressed in the icosapent ethyl group and progressed in the placebo group, (p<0.01 for all). the only secondary endpoint which did not achieve a significant difference between groups in multivariable modeling was dense calcium (p="0.053)." the mineral oil placebo, used for consistency with reduce-it, was also analyzed against plaque changes from baseline in another placebo in a separate study. rates of plaque changes in patients randomized to mineral oil (the placebo cohort) in the evaporate study were compared with rates of plaque changes in the placebo arm of a second study that used a cellulose-based placebo. there was no difference in plaque progression between mineral oil and cellulose based placebos.see: "effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: final results of the evaporate trial" matthew j budoff et al. european heart journal, ehaa652, 29 august 2020 https: doi.org 10.1093 eurheartj ehaa652>