The newly approved US indication for icosapent ethyl (Vascepa, Amarin) is broadly in line with the entry criteria for the REDUCE-IT trial and includes a large high-risk primary prevention population, as well as those with established cardiovascular disease (CVD).
The high-dose, purified eicosapentaenoic acid (EPA) product was approved last week by the US Food and Drug Administration (FDA) for cardiovascular risk reduction among adults already taking maximally tolerated statins with triglyceride levels of 150 mg/dL or higher who have either established CVD or diabetes and two or more additional risk factors for CVD.
The approval is based largely on the REDUCE-IT trial"s finding of a 25% reduction in risk for major adverse cardiovascular events vs placebo.
The drug was unanimously recommended for approval by the FDA"s Endocrinologic and Metabolic Drugs Advisory Committee last month. But while the committee all agreed on its use in patients with established CVD, which made up 70% of the REDUCE-IT population, they were divided on whether the indication should be extended to the high-risk primary prevention population, who made up just 30% of patients in the study.
