The Road to Approval: a Perspective on the Role of Icosapent Ethyl in Cardiovascular Risk Reduction.

ABSTRACT

PURPOSE OF REVIEW Epidemiological studies have long suggested the cardiovascular benefits of omega-3 fatty acids (OM3FAs). However, until recently, clinical trials using OM3FAs have been largely negative with respect to their cardioprotective effects. In this review, we aim to summarize key clinical trials, examine the clinical benefits of eicosapentaenoic acid (EPA) and potential mechanisms, and review the changes in guidelines and recommendations. RECENT FINDINGS: The Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT) has demonstrated significant cardiovascular mortality benefits of purified EPA ethyl ester, with a 25% relative risk reduction in major cardiovascular events. As first of its class to be approved, icosapent ethyl offers a new option to further reduce cardiovascular risks in patients already treated with maximally tolerated statins.