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]). The key secondary composite end point included time to first occurrence of CV death, myocardial infarction, or stroke (3-point MACE).
Results showed that treatment with Vascepa significantly reduced the risk of the primary composite end point (17.2% vs 22%; hazard ratio [HR] 0.75; 95% CI, 0.68-0.83; P <.0001) and the key secondary composite end point (11.2% vs 14.8%; HR 0.74; 95% CI, 0.65-0.83; P <.0001), compared with placebo. Additionally, a series of statistical models were used to conduct recurrent event analyses of the total primary and secondary end points in REDUCE-IT, which were published in the Journal of the American College of Cardiology. Findings from the recurrent event analyses were consistent with the original primary and secondary end point results, which support the clinical benefit of Vascepa in reducing CV risk.
With regard to safety, the most common treatment-emergent adverse reactions reported in the cardiovascular outcomes trial were musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. Study data also showed that treatment with Vascepa was associated with an increased risk of bleeding and atrial fibrillation or atrial flutter requiring hospitalization; the incidence of atrial fibrillation was found to be greater in patients with a previous history of atrial fibrillation/flutter.
Vascepa, an ethyl ester of eicosapentaenoic acid (EPA), is already approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500mg/dL) hypertriglyceridemia. It is supplied in 0.5g and 1g capsules.
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