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Omega-3 Carboxylic Acids (Epanova®): A Review of Its Use in Patients with Severe Hypertriglyceridemia

  • Adis Drug Evaluation
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American Journal of Cardiovascular Drugs Aims and scope Submit manuscript

Abstract

Omega-3 carboxylic acids (Epanova®) [OM3-CA] is the first free fatty acid form of long-chain marine omega-3 fatty acids (eicosapentaenoic acid and docosahexaenoic acid being the most abundant) to be approved by the US FDA as an adjunct to diet to lower triglyceride levels in patients with severe hypertriglyceridemia (≥500 mg/dL). Oral OM3-CA has greater bioavailability than ethyl ester forms of omega-3 and, unlike omega-3 acid ethyl esters, does not require co-ingestion of a high-fat meal, as it does not need pancreatic enzyme activity for absorption. In the 12-week EpanoVa fOr Lowering Very high triglyceridEs (EVOLVE) trial, OM3-CA 2 or 4 g/day significantly reduced serum triglyceride levels relative to placebo. Other lipid parameters, including non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, and very low-density lipoprotein cholesterol (VLDL-C) levels, were also reduced significantly with OM3-CA relative to placebo. Low-density lipoprotein cholesterol levels were increased significantly with OM3-CA relative to placebo; however, these increases were not accompanied by increases in the circulating concentrations of non-HDL-C, VLDL-C, or apolipoprotein B. OM3-CA was generally well tolerated in this study, with most adverse events being of mild or moderate severity. Although additional comparative data are needed to position OM3-CA with respect to other formulations of omega-3 fatty acids, current evidence suggests that OM3-CA is a useful addition to the treatment options available for patients with severe hypertriglyceridemia.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the authors on the basis of scientific and editorial merit. Hannah Blair and Sohita Dhillon are salaried employees of Adis/Springer.

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Correspondence to Hannah A. Blair.

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The manuscript was reviewed by: L. Berglund, UC Davis CTSC, University of California, Davis, Sacramento, CA, USA; K. C. Maki, Midwest Center for Metabolic & Cardiovascular Research, Clinical Research, Chicago, IL, USA; E. Offman, Celerion, Montreal, QC, Canada.

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Blair, H.A., Dhillon, S. Omega-3 Carboxylic Acids (Epanova®): A Review of Its Use in Patients with Severe Hypertriglyceridemia. Am J Cardiovasc Drugs 14, 393–400 (2014). https://doi.org/10.1007/s40256-014-0090-3

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  • DOI: https://doi.org/10.1007/s40256-014-0090-3

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