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Omega-3-acid Ethyl Esters

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Omega-3-acid ethyl esters is a prescription fish-oil-derived preparation containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as their ethyl esters, indicated as an adjunct to diet for adults with severe hypertriglyceridemia (triglycerides at least 500 mg/dL)[1]. It is distinct from Icosapent Ethyl (Vascepa), which is purified EPA ethyl ester only; the cardiovascular-outcomes evidence supporting icosapent ethyl in REDUCE-IT does not extend to mixed EPA+DHA preparations, and the STRENGTH trial of a related carboxylic-acid omega-3 formulation was stopped early for futility[citation needed].

Omega-3-acid ethyl esters
Lovaza, Omtryg

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Summary
Common uses
Severe hypertriglyceridemia (TG at least 500 mg/dL)0
Pharmacy
Starting dose
4 g PO daily (as 4 x 1 g capsules once daily, or 2 capsules BID)
Preparations
1 g soft gelatin capsules containing ~465 mg EPA + ~375 mg DHA as ethyl esters
US FDA Max
4 g/d
Pharmacology
Routes
Oral
Onset
Triglyceride lowering at 2-4 weeks; max at 8 weeks
Duration
Daily dosing
Half-life
Not well characterized; tissue incorporation over weeks[1]
Bioavailability
Improved with food[1]
Pregnancy
Limited human data[citation needed]
Legal status
Rx-only in US
Purported mechanism
Omega-3-acid ethyl esters lower serum triglycerides primarily by reducing hepatic VLDL-triglyceride synthesis and increasing fatty-acid oxidation; LDL may rise modestly in the mixed EPA+DHA preparations, unlike the pure-EPA icosapent ethyl.0 The EPA+DHA mix is biochemically and clinically distinct from icosapent ethyl[1].

References

  1. 1.0 1.1 1.2 1.3 FDA Prescribing Information, Lovaza (omega-3-acid ethyl esters), GlaxoSmithKline, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021654s018lbl.pdf