Substrate for E-series Resolvins (specialised pro-resolving mediators)
Competes with arachidonic acid for COX/LOX enzymes (anti-eicosanoid effect)
Triglyceride-lowering via hepatic VLDL secretion modulation
Molecular + tissue targets
Plasma triglycerides
Cardiovascular composite outcomes in elevated-triglyceride statin-treated populations
Inflammatory pathway resolution
Dosage range
REDUCE-IT (Bhatt 2019 PMID 30415628 NEJM n=8,179 statin-treated with elevated triglycerides) used 4 g/day icosapent ethyl (prescription EPA ester) for a 25% reduction in the primary cardiovascular composite endpoint (CV death + nonfatal MI + nonfatal stroke + coronary revascularization + hospitalised unstable angina) over median 4.9 years. Dietary supplement pure EPA at 1-2 g/day is widely used but does not replicate the prescription 4 g/day evidence base
Safety notes
Atrial fibrillation signal observed at the 4 g/day icosapent ethyl dose (REDUCE-IT secondary analysis); modest bleeding risk at very high doses (anticoagulant interaction); the high-EPA frame is distinct from the EPA+DHA blend frame and should not be conflated with dietary fish-oil RDAs
Cross-market regulatory status
🇺🇸 FDA
Icosapent ethyl (Vascepa) is a prescription drug indicated as an adjunct to statin therapy for CV risk reduction in elevated-triglyceride adults; dietary supplement EPA is GRAS · DSHEA framework · qualified health claims under the omega-3 framework when EPA+DHA blend dose threshold met
🇪🇺 EFSA
Authorized claim Reg 432/2012 EPA+DHA cardiovascular (EPA component contributes within blend threshold); no standalone EPA-only authorized claim
🇧🇷 ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 Anexo V alegação funcional verbatim: "Os ácidos graxos ômega 3 EPA e DHA auxiliam na redução dos triglicerídeos." (≥ 1.500 mg EPA+DHA/dia · EPA-only formulations meet the EPA+DHA combined threshold when dose adequate)
Authorized claims · verbatim (2)
Direct quotes from each jurisdiction's framework · never paraphrased · with framework reference and conditions of use.
🇪🇺 EFSA · 1 claim
Reg 432/2012
EPA and DHA contribute to the normal function of the heart.
Conditions: Reg 1924/2006 art 10(2): claim may be used only for food which provides a daily intake of at least 250 mg of EPA and DHA; consumer informed that the beneficial effect is obtained with a daily intake of 250 mg of EPA and DHA
Authorized 2012
🇧🇷 ANVISA · 1 claim
IN 28/2018 Anexo V alegação funcional
Os ácidos graxos ômega 3 EPA e DHA auxiliam na redução dos triglicerídeos.
Conditions: IN 28/2018 Anexo V: alegação restrita a suplementos que forneçam ao menos 1.500 mg de EPA + DHA por dia
Authorized 2018
Common use cases
triglyceride lowering and cardiovascular risk reduction in statin-treated adults with elevated triglycerides (per icosapent ethyl evidence base)
targeted EPA dosing when whole-fish-oil EPA+DHA blend not desired