REDUCE-IT: Icosapent Ethyl Shows Significant Reduction in Coronary Revascularizations

May 19, 2020

Analyses showed that times to first revascularization events were significantly reduced by icosapent ethyl vs placebo across subtypes of intervention.

Results from the phase III REDUCE-IT study show that icosapent ethyl (Vascepa, Amarin) significantly reduced first coronary revascularizations and total revascularizations by 34% and 36%, respectively, compared with placebo, according to a press release from Amarin Corporation.

REDUCE-IT, a multicenter, randomized, double-blind, placebo-controlled study, included 8179 patients aged ≥45 years with established cardiovascular disease (CVD) or at high risk for CVD, 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

“These findings from the REDUCE-IT study put in further context the broad-reaching impact of icosapent ethyl on reducing the burden of cardiovascular disease for patients,” commented Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital Heart & Vascular Center, professor of medicine at Harvard Medical School, and senior author of the REDUCE-IT REVASC analyses, in the Amarin release.

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“To the best of our knowledge, this is the first non-LDL cholesterol intervention in a major randomized trial in which analyses support that statin-treated patients underwent fewer CABG surgeries, further highlighting the substantial impact of icosapent ethyl on the underlying atherothrombotic burden in this at-risk population.”

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Patients in the REDUCE-IT study had LDL-C controlled on statin therapy with persistent elevated triglycerides and had either CVD or diabetes and additional CV risk factors.

Time to first event reduced across interventions

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).

Prespecified tertiary endpoint analyses showed that times to first revascularization events were significantly reduced by icosapent ethyl vs placebo across subtypes of intervention, including urgent, emergent, and elective revascularizations, which were reduced by 34% (p<.0001), 38% (p=0.02), and 32% (p<.0001), respectively.

In post hoc analyses, by icosapent ethyl significantly reduced percutaneous coronary intervention by 32% (p<0.0001) and coronary artery bypass grafting by 39% relative to placebo (p=0.0005).

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 levels (≥150mg/dL) and established 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).