Icosapent Ethyl
Icosapent ethyl (eicosapentaenoic acid ethyl ester, EPA-EE)
Vascepa
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Summary
Common uses
Cardiovascular risk reduction in patients with elevated triglycerides on statin therapy (REDUCE-IT)0, Severe hypertriglyceridemia (≥500 mg/dL)0
Pharmacy
Starting dose
2 g PO BID with meals (4 g/d total)
Preparations
0.5 g, 1 g capsules
US FDA Max
4 g/d
Pharmacology
Routes
Oral
Onset
Triglyceride lowering at 4-8 weeks; CV benefit emerges over months
Duration
12 hours
Half-life
~89 hours (EPA, the active metabolite)[1]
Bioavailability
Substantially improved with high-fat meal; take with food[1]
Pregnancy
Limited data.[citation needed]
Legal status
Rx-only in US
Purported mechanism
Icosapent ethyl is a highly purified ethyl ester of EPA (eicosapentaenoic acid, 20:5 n-3); EPA reduces hepatic VLDL-triglyceride synthesis, raises lipoprotein lipase activity, and has pleiotropic anti-inflammatory, antiplatelet, and membrane-stabilizing effects whose contributions to the REDUCE-IT cardiovascular benefit remain debated.0 Unlike combined EPA+DHA preparations (Lovaza), pure EPA does not raise LDL — the structural basis for FDA approval after REDUCE-IT showed a 25% relative risk reduction in CV events over statin therapy alone in high-risk patients. Atrial fibrillation signal is the principal new safety concern emerging from the trial[1].
References
- ↑ 1.0 1.1 1.2 FDA Prescribing Information, Vascepa (icosapent ethyl), Amarin, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202057s035lbl.pdf