For research and educational purposes only. Not medical advice.
Icosapent ethyl Reference
Educational, not medical advice reference for Icosapent ethyl: Metabolic; regulatory status, evidence posture, source review, and schedule notes. Also known…
Reference summary
REDUCE-IT (Bhatt 2019 NEJM, n=8,179) randomized statin-treated patients with elevated triglycerides to icosapent ethyl 4 g/day vs mineral oil placebo and reported a 25 percent relative reduction in the primary composite cardiovascular endpoint over a median 4.9 years. The mineral-oil-placebo comparator has been a source of methodological debate (STRENGTH was neutral with a different EPA+DHA formulation, raising questions about whether the REDUCE-IT signal is fully attributable to icosapent ethyl). Both controversies are summarized in the pepSmart omega-3 cardiovascular evidence article.
Regulatory and posture
- Categories
- Metabolic
- Aliases
- Vascepa, Ethyl eicosapentaenoate, Highly purified EPA ethyl ester (small molecule, not a peptide)
- Evidence posture
- human
- Regulatory status
- FDA-approved as Vascepa (2012) for severe hypertriglyceridemia (TG at or above 500 mg/dL) and (2019, label expansion) for cardiovascular event reduction as an adjunct to maximally tolerated statin therapy in adults with TG at or above 150 mg/dL plus either established cardiovascular disease or diabetes plus at least 2 additional CV risk factors.
- Content review status
- label verified