A Comprehensive Monograph on Icosapent Ethyl: From Molecular Pharmacology to a New Paradigm in Cardiovascular Risk Reduction

Executive Summary

Icosapent ethyl (IPE), marketed under the brand names Vascepa® and Vazkepa®, is a high-purity, prescription-grade ethyl ester of eicosapentaenoic acid (EPA), a naturally occurring omega-3 fatty acid.[1] Its formulation as a single-molecule, EPA-only product distinguishes it fundamentally from over-the-counter fish oil supplements and other prescription omega-3 fatty acid therapies, which typically contain a mixture of EPA and docosahexaenoic acid (DHA). This distinction is clinically paramount, as IPE avoids the elevation in low-density lipoprotein cholesterol (LDL-C) that can be associated with DHA-containing products.[4]

The medication holds two primary indications approved by the U.S. Food and Drug Administration (FDA) and other global regulatory bodies. The first is as an adjunct to diet for the reduction of triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG levels $ \geq 500 \text{ mg/dL} $). The second, and more transformative, indication is as an adjunct to maximally tolerated statin therapy to reduce the risk of major adverse cardiovascular events in high-risk adult patients with elevated triglycerides (TG levels $ \geq 150 \text{ mg/dL} $).[2]