New findings from the phase 3 REDUCE-IT trial, published online March 18 in the Journal of the American College of Cardiology, demonstrate Vascepa reduced not only first but subsequent cardiovascular events among high-risk patients already receiving statin therapy. The trial randomized 8,179 statin-treated patients with triglycerides between 135 mg/dL and 500 mg/dL and LDL-cholesterol levels between 40 mg/dL and 100 mg/dL to either Vascepa 4 g daily or placebo. Of these patients, 71% had a history of atherosclerosis, and 29% had a history of diabetes. Throughout the trial period of 4.9 years, 2,909 cardiovascular events occurred within the study population, of which 1,606 were first events and 1,303 were subsequent events, including cardiovascular deaths, nonfatal heart attacks or strokes, coronary revascularization, and hospitalization for unstable angina. Compared with placebo, the Vascepa group experienced a 25% reduction of first events, 32% of second events, 31% of third events, and 48% of fourth or more events. Vascepa was well tolerated, although there was an increased incidence of atrial fibrillation and serious bleeding compared with the placebo group. However, the overall rates of these adverse effects were low and did not increase the risk of stroke.
Amarin, the manufacturer of Vascepa, plans to submit an application to the FDA by the end of March to include the CV benefit on Vascepa’s label.
About Vascepa (Icosapent ethyl)
Vascepa is a highly purified form of the omega-3 fatty acid, eicosapentaenoic acid (EPA), that’s found in fish oil. EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles.
Vascepa was approved by the FDA in July of 2012 as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (TG greater than or equal to 500mg/dL) hypertriglyceridemia (very high triglycerides).