Omega-3 Fatty Acid (Purified EPA — Eicosapentaenoic Acid Ethyl Ester) Pregnancy: Use with caution — limited data; EPA crosses placenta; avoid high-dose omega-3 supplements unless clearly indicated.

Icosapent Ethyl (Omega-3 — Cardiovascular Risk Reduction)

Brand names: Vascepa

Adult dose

Dose: 4 g daily (2 g twice daily with food)

Route: Oral (soft gelatin capsule)

Frequency: Twice daily with food

Max: 4 g/day

Purified EPA ethyl ester (not DHA — DHA may raise LDL-C; EPA alone reduces CV risk without this effect). FDA approved for CV risk reduction in patients with elevated triglycerides (≥135 mg/dL / ≥1.5 mmol/L) on maximally-tolerated statin therapy with established CVD or diabetes + risk factors. NICE appraisal in progress (2024).

Paediatric dose

Route:

Not licensed in paediatrics for CV risk indication.

Dose adjustments

Renal

No dose adjustment required.

Hepatic

Caution in severe hepatic impairment.

Clinical pearls

REDUCE-IT trial (Bhatt et al. NEJM 2018): icosapent ethyl 4 g/day vs mineral oil placebo in statin-treated patients with elevated TG + established CV disease or DM — 25% relative risk reduction in primary composite endpoint (CV death, MI, stroke, coronary revascularisation, unstable angina); NNT approximately 21 over 4.9 years. Landmark result
AF risk — MHRA alert (2021): FDA and MHRA highlighted increased AF/flutter incidence (2–3% absolute) in REDUCE-IT — clinically relevant in older patients with AF risk factors (hypertension, obesity, existing paroxysmal AF). Monitoring ECG or symptom review is advised
Mechanism debate: the magnitude of benefit in REDUCE-IT exceeded that expected from TG reduction alone, suggesting pleiotropic effects of EPA — including anti-inflammatory (EPA incorporated into membrane phospholipids), plaque stabilisation, and reduced oxidised LDL. The mineral oil control also likely inflated the treatment effect by worsening biomarkers in the placebo group — an ongoing controversy (STRENGTH trial with omega-3+DHA showed no benefit)

Contraindications

Known fish or shellfish allergy (EPA is fish-derived)
Hypersensitivity to icosapent ethyl

Side effects

Atrial fibrillation/flutter (2–3% increase vs placebo — significant; MHRA warning: monitor for AF in high-risk patients)
Peripheral oedema
Musculoskeletal pain
Constipation
Gout (uric acid increases slightly)
Mild antiplatelet effect (additive with antiplatelets/anticoagulants)

Interactions

Anticoagulants and antiplatelets (mild antiplatelet effect — monitor bleeding; does not generally require dose adjustment)
Other lipid-lowering agents (combination with statins — the study population; additive lipid-lowering effects)

Monitoring

Fasting lipid profile (TG reduction confirmation — target <1.7 mmol/L)
LFTs (at baseline and periodically)
ECG/symptoms for AF (MHRA AF warning)
Bleeding signs (antiplatelet effect)
Blood glucose (modest benefit in insulin resistance)

Reference: BNFc; BNF 90; REDUCE-IT Trial (Bhatt et al. NEJM 2018); FDA Prescribing Information Vascepa; MHRA Drug Safety Update 2021 (AF risk); ESC Dyslipidaemia Guidelines 2019. Verify against your local formulary and the latest BNF before prescribing.

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways