Amarin Corporation announced results from the phase 3 REDUCE-IT study of icosapent ethyl (Vascepa) demonstrating a significant reduction in coronary revascularization procedures in high risk patients with mixed dyslipidemia.
The multicenter, randomized, double-blind, placebo-controlled study included 8179 patients aged ≥45 years with established cardiovascular (CV) disease or at high risk for CV disease, who have hypertriglyceridemia and elevated low-density lipoprotein cholesterol levels (LDL-C) controlled by statin therapy. Patients were randomized to receive 2g of icosapent ethyl twice daily or placebo.
Results showed that icosapent ethyl significantly reduced first coronary revascularizations and total (first and subsequent) revascularizations by 34% and 36%, respectively, compared with placebo (P <.0001). Additional analyses of prespecified tertiary end points showed that icosapent ethyl reduced the time to first urgent, emergent and elective revascularization events by 34% (P <.0001), 38% (P=.02), and 32% (P <.0001), respectively, compared with placebo.
In post hoc analysis, icosapent ethyl was associated with significant reductions in percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) by 32% (P <.0001) and 39% (P=.0005), respectively, compared with placebo.
“We were able to show that treating patients with icosapent ethyl who have elevated triglycerides on statin therapy, and who also have either cardiovascular disease or diabetes plus cardiovascular risk factors, resulted in a significant reduction in revascularization, including coronary stenting and cardiac bypass surgery,” said Benjamin Peterson, MD, interventional cardiology fellow at Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, and lead author of the REDUCE-IT REVASC analyses.
Vascepa is currently approved 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. It is also indicated as an adjunct to diet to reduce TG levels in adults with severe hypertriglyceridemia (≥500mg/dL).
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