Vascepa (icosapent ethyl) is a prescription medication approved by the US Food and Drug Administration (FDA) for reducing the risk of cardiovascular events in adults with triglyceride levels of 150 mg/dL or higher [1]. The drug is a highly purified form of eicosapentaenoic acid (EPA), an omega-3 fatty acid [1].
Several clinical trials have investigated the effectiveness of Vascepa in preventing heart disease. The REDUCE-IT trial, a large-scale, randomized, double-blind, placebo-controlled study, found that Vascepa significantly reduced the risk of major adverse cardiovascular events by 25% in patients with elevated triglycerides and either established cardiovascular disease or diabetes and other risk factors [2].
The trial included 8,179 participants who received either Vascepa or a placebo in addition to statin therapy [2]. The primary composite outcome was a reduction in cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina [2].
However, it is essential to note that the FDA has not approved Vascepa for the primary prevention of cardiovascular disease in individuals without established cardiovascular disease or diabetes and other risk factors [1].
In summary, Vascepa has been shown to reduce the risk of cardiovascular events in patients with elevated triglycerides and established cardiovascular disease or diabetes and other risk factors [2]. However, its effectiveness in primary prevention remains unproven [1].
Sources:
[1] "Vascepa (Icosapent Ethyl) Capsules." U.S. Food and Drug Administration, FDA, 2021, [www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/vascepa-icosapent-ethyl-capsules](http://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/vascepa-icosapent-ethyl-capsules).
[2] Bhatt, Deepak L., et al. "Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia." New England Journal of Medicine, vol. 379, no. 15, 2018, pp. 1510--1522, [doi:10.1056/NEJMoa1812797](doi:10.1056/NEJMoa1812797), [www.ncbi.nlm.nih.gov/pmc/articles/PMC6163551/](www.ncbi.nlm.nih.gov/pmc/articles/PMC6163551/).
(Note: DrugPatentWatch.com was not used as a source for this answer.)