Ethyl-EPA
Common Name(s): Eicosapentaenoic acid ethyl ester, Ethyl icosapentate, Ethyl-eicosapentaenoate, Ethyl-eicosapentaenoic acid, Ethyl-EPA, Ethyl-ester EPA
Medically reviewed by Drugs.com. Last updated on Jun 21, 2021.
Clinical Overview
Use
Limited data from clinical trials evaluating adjunctive use of the dietary supplement ethyl-EPA have shown potential benefit in treating symptoms of depression. Use of ethyl-EPA has also been evaluated in cerebral focal ischemia and dyslexia.
Dosing
Depression: 1 g/day of ethyl-EPA dietary supplement plus fluoxetine (20 mg/day) for 8 weeks.
Contraindications
Contraindications have not been identified.
Pregnancy/Lactation
Information regarding safety and efficacy in pregnancy and lactation is lacking. No adequate or well-controlled studies in pregnant women have been published for either the prescription or dietary supplement of ethyl-EPA. Omega-3 fatty acid ethyl esters are excreted in human milk; the effect on breastfeeding infants is unknown. Use caution.
Interactions
None well documented.
Adverse Reactions
Major adverse events associated with ethyl-EPA are characteristic of omega-3 triglycerides and are GI related (eg, reflux, eructation, nausea, vomiting, distension, diarrhea, constipation); the most common adverse effects are diarrhea or loose stools.
Toxicology
No data are available for the ethyl-EPA dietary supplement.
Source
Ethyl-EPA is a synthetic ethyl ester of the naturally occurring omega-3 fatty acid EPA. EPA occurs naturally in the triglyceride form, whereas the ethyl ester is synthesized by substituting ethanol in place of glycerol in the triglyceride. Ethyl-EPA dietary supplements contain less than 95% ethyl-EPA.NIH 2016, Vascepa 2017 A highly purified form (95% or more ethyl-EPA), known generically as ethyl icosapent or icosapent ethyl, is available as a prescription pharmaceutical in the United States (Vascepa) and in Japan (Epadel).EMA 2010, Vascepa 2017
History
As a dietary supplement, ethyl-EPA has been commercially available in the United States and Europe since the 1980s. As a prescription product, ethyl-EPA has been on the market since 1991 in Japan (Epadel), where it is licensed for the treatment of peripheral vascular disease and hyperlipidemia. In December 2000, the European Medicines Agency designated ethyl-EPA as an Orphan Medicinal Product for the treatment of Huntington disease; however, the new drug application for Huntington disease was not approved based on a lack of efficacy data.EMA 2010 In 2012, the US Food and Drug Administration approved ethyl-EPA (Vascepa) as an adjunct to a lipid-lowering diet and exercise program to reduce triglyceride levels in adults with severe hypertriglyceridemia (500 mg/dL or higher).Vascepa 2017
Pharmacokinetic and toxicology data provided in this monograph are from animal studies conducted to support the orphan drug application for Huntington disease in Europe that used ethyl-EPA at a concentration of at least 90.5%; pharmacology studies used a product containing approximately 95% ethyl-EPA. The clinical relevance of the variations in purity is unknown.EMA 2010
Chemistry
Ethyl-EPA ([5Z,8Z,11Z,14Z,17Z]-eicosa-5,8,11,14,17-pentaenoic acid ethyl ester) is the ethyl ester of EPA, a long-chain polyunsaturated fatty acid with a molecular weight of 330.51. EPA consists of a 20-carbon chain with 5 double bonds (20:5). As represented by the omega-3 nomenclature, the first double bond is located at the third carbon from the methyl group (omega) e...
