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Lipid-Lowering Agents Pregnancy: Avoid unless clearly necessary — limited data; omega-3 fatty acids cross placenta; discuss risk/benefit

Icosapent Ethyl

Brand names: Vascepa

Adult dose

Dose: 2 g twice daily (total 4 g/day)
Route: Oral
Frequency: Twice daily with food
Max: 4 g/day
Take with food. Swallow capsules whole — do not crush or chew. Maintain statin therapy. Licensed dose for CV risk reduction is 4 g/day.

Paediatric dose

Dose: Seek specialist opinion N/A/kg
Route: Oral
Frequency: N/A
Max: N/A
Not established in paediatrics; seek specialist paediatric lipidology opinion

Dose adjustments

Renal

No dose adjustment required

Hepatic

No specific dose adjustment; use with caution in severe hepatic impairment

Paediatric weight-based calculator

Not established in paediatrics; seek specialist paediatric lipidology opinion

Clinical pearls

  • Mechanism: highly purified EPA (eicosapentaenoic acid) ethyl ester — reduces triglycerides via VLDL-TG synthesis inhibition; beyond TG reduction, reduces arachidonic acid incorporation into membranes (anti-inflammatory), stabilises plaque lipid cores, reduces oxidative stress; distinct mechanisms from mixed omega-3 supplements
  • REDUCE-IT trial (NEJM 2018): icosapent ethyl 4 g/day vs mineral oil placebo in high-TG (above 1.69 mmol/L) statin-treated patients — 25% relative risk reduction in 5-point MACE; NNT 21 over 4.9 years; CV death, non-fatal MI, non-fatal stroke, revascularisation, unstable angina all reduced
  • Controversy — mineral oil placebo: STRENGTH trial (mixed omega-3 with DHA+EPA) used corn oil placebo and showed NO benefit; critics argue REDUCE-IT benefit partly artefactual (mineral oil increased LDL and hs-CRP in control arm); debate ongoing but REDUCE-IT remains landmark trial
  • MHRA approval: Vascepa approved EU 2021 for CV risk reduction (alongside statins) in adults with TG above 1.5 mmol/L and high CV risk or established CVD; NICE TA805 (2022) approved on same basis
  • AF risk: significant increase in AF/flutter — discuss with patient before prescribing; avoid or use with caution in patients with existing AF risk factors
  • Pure EPA vs DHA: DHA-containing omega-3 supplements (fish oil) raise LDL-C in some patients; icosapent ethyl is pure EPA — does NOT raise LDL-C

Contraindications

  • Known hypersensitivity to icosapent ethyl or fish
  • Active bleeding disorders (relative — antiplatelet effect)

Side effects

  • Atrial fibrillation and atrial flutter (increased risk — REDUCE-IT and STRENGTH trials; 5.3% vs 3.9%)
  • Peripheral oedema
  • Constipation
  • Musculoskeletal pain
  • Bleeding (mild antiplatelet effect)
  • Gout flare (rare)

Interactions

  • Anticoagulants and antiplatelets (additive antiplatelet effect — monitor for bleeding)
  • NSAIDs (additive bleeding risk)

Monitoring

  • Fasting triglycerides at baseline and 12 weeks (efficacy)
  • Fasting lipid panel
  • ECG or cardiac monitoring for AF symptoms
  • INR or anti-Xa if on warfarin or anticoagulation (bleeding risk)

Reference: BNFc; BNF 90; REDUCE-IT trial NEJM 2018;380(1):11-22; NICE TA805; MHRA approval 2021; ESC/EAS Lipid Guidelines 2019. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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