Differentiating prescription omega-3-acid ethyl esters (P-OM3) from dietary-supplement omega-3 fatty acids.

BACKGROUND

A reliable means of treating hyper-triglyceridemia is the use of large doses of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Modest levels of EPA and DHA may be obtained from food, particularly fatty fish.

OBJECTIVES

This article is intended to review clinically relevant differences between dietary-supplement omega-3 fatty acids and prescription omega-3-acid ethyl esters (P-OM3).

METHODS

PubMed and the Food and Drug Administration (FDA) Website were searched for articles published between 1995 and 2007 that contained the terms fish oil, fatty acids, n-3 fatty acids, omega fatty acids, docosahexaenoic acid, or eicosapentaenoic acid. Articles discussing sources, recommended intake, and differences among various formulations of omega-3 fatty acids were selected for review. A limitation to this review is the lack of head-to-head clinical trials using P-OM3 and dietary-supplement omega-3 fatty acids.

RESULTS

Many types of nonprescription dietary supplements of omega-3 fatty acids are available; however, the efficacy, quality, and safety of these products are open to question because they are not regulated by the same standards as pharmaceutical agents. P-OM3 is the only omega-3 fatty acid product (Omacor capsules) approved by the US FDA available in the United States as an adjunct to diet to reduce very high (> or = 500 mg/dL) triglyceride levels in adult patients.

CONCLUSIONS

P-OM3 can be used with confidence by practitioners who want to provide therapeutic doses of omega-3 fatty acids in a preparation that has been documented to be both safe and effective.