Icosapent ethyl for the treatment of hypertriglyceridemia.

INTRODUCTION

Icosapent ethyl (IPE; Vascepa) is a high-purity prescription form of eicosapentaenoic acid (EPA) ethyl ester recently approved in 2012 to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Elevated TG levels are associated with increased risk for coronary heart disease. Currently available TG-lowering agents (fibrates, niacins, omega-3 fatty acid products containing both EPA and docosahexaenoic acid [DHA]) may be associated with adverse effects such as flushing, hepatotoxicity, myopathy, elevated glucose levels, and/or increases in low-density lipoprotein cholesterol (LDL-C).

AREAS COVERED

This review describes IPE chemistry, pharmacokinetics, and clinical studies. In two Phase III randomized, placebo-controlled trials, one in patients with very high TG levels (≥ 500 mg/dL; MARINE) and the other in statin-treated patients at high cardiovascular risk with well-controlled LDL-C and residual high TG levels (≥ 200 to < 500 mg/dL; ANCHOR), IPE lowered levels of TG, non-high-density lipoprotein cholesterol, and other atherogenic lipoproteins without increasing LDL-C levels.

EXPERT OPINION

IPE is safe and effective for managing high TG levels, and it offers a new alternative with potential benefits over currently available treatments for dyslipidemia. The ongoing cardiovascular outcomes REDUCE-IT trial will provide valuable information on the efficacy of IPE to prevent cardiovascular events in high-risk patients already taking statins.