The Food and Drug Administration (FDA) has approved the use of Vascepa (icosapent ethyl; Amarin Pharma) as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (150mg/dL) and established CV disease or diabetes mellitus and 2 or more additional risk factors for CV disease. The approval was based on data from the phase 3 REDUCE-IT trial that assessed the CV outcomes of 8179 patients who were administered Vascepa as an add-on to statins, and who had elevated TG levels (135mg/dL) with either CV disease or diabetes and other CV risk factors. The primary composite end point included time to first occurrence of CV death, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina (5-point major adverse cardiovascular event [MACE]) Continue reading
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