Icosapent ethyl for the treatment of hypertriglyceridemia

• Published in: Expert opinion on pharmacotherapy Vol. 14; no. 10; p. 1409
• Main Authors: Ballantyne, Christie M, Braeckman, Rene A, Soni, Paresh N
• Format: Journal Article
• Language: English
• Published: England 01.07.2013
• Subjects: Dietary Supplements; Drug Approval; Eicosapentaenoic Acid - analogs & derivatives; Eicosapentaenoic Acid - chemistry; Eicosapentaenoic Acid - pharmacology; Eicosapentaenoic Acid - therapeutic use; Humans; Hypertriglyceridemia - drug therapy; Hypertriglyceridemia - metabolism; Hypolipidemic Agents - chemistry; Hypolipidemic Agents - pharmacology; Hypolipidemic Agents - therapeutic use; Treatment Outcome; United States; United States Food and Drug Administration
• ISSN: 1744-7666
• DOI: 10.1517/14656566.2013.798645

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). 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. 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.