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ATP Citrate Lyase (ACL) Inhibitor Pregnancy: Avoid — insufficient data; potential effects on fetal cholesterol synthesis; effective contraception required

Bempedoic Acid

Brand names: Nilemdo (monotherapy), Nustendi (+ ezetimibe)

Adult dose

Dose: 180 mg once daily (monotherapy or with ezetimibe 10 mg in Nustendi)
Route: Oral
Frequency: Once daily (with or without food)
Max: 180 mg/day
Primary hypercholesterolaemia or mixed dyslipidaemia — adjunct to diet in statin-intolerant patients or as add-on to maximally tolerated statin; Nustendi (bempedoic acid + ezetimibe) combination tablet simplifies therapy

Paediatric dose

Dose: Not established N/A/kg
Route: N/A
Frequency: N/A
Max: N/A
Not licensed in paediatrics

Dose adjustments

Renal

No dose adjustment for mild-moderate impairment; severe renal impairment: avoid

Hepatic

No dose adjustment for mild impairment; moderate-severe: avoid

Paediatric weight-based calculator

Not licensed in paediatrics

Clinical pearls

  • CLEAR trial (Nissen et al. NEJM 2023): bempedoic acid significantly reduced major adverse cardiovascular events (MACE) by 13% vs placebo in statin-intolerant patients — first oral non-statin lipid-lowering drug to show CV outcome benefit; pivotal trial for NICE TA898 approval
  • Liver-specific activation: bempedoic acid is a prodrug — activated by ACSVL1 enzyme expressed only in the liver (not muscle); inhibits ACL upstream of HMG-CoA reductase; because activation occurs in liver (not skeletal muscle), myopathy risk is absent — key advantage over statins in statin-intolerant patients
  • Gout risk: bempedoic acid inhibits urate transporters in renal tubule, increasing serum uric acid — new gout events in ~2% vs 1% placebo; monitor uric acid; caution in patients with gout history; consider allopurinol prophylaxis in high-risk patients
  • Tendon rupture: rare but MHRA warning — mechanism unclear; particular caution in patients also on fluoroquinolones (additive tendinopathy risk) or with prior tendon disease; counsel patients to report tendon pain
  • Statin-intolerance positioning: for patients who cannot tolerate statins due to myalgia — bempedoic acid (oral) ± ezetimibe provides meaningful LDL-C reduction (~25% bempedoic acid alone, ~38% with ezetimibe combination) without statin-related muscle toxicity

Contraindications

  • Known hypersensitivity
  • Concurrent use of simvastatin >20 mg or pravastatin >40 mg (increases statin exposure — transport inhibition)

Side effects

  • Hyperuricaemia/gout (uricosuric effect inhibited — increase in serum urate)
  • Tendon rupture (rare but MHRA warning)
  • Anaemia
  • Elevated creatinine (benign — tubular secretion inhibition)
  • Elevated LFTs (mild)
  • Back pain

Interactions

  • Simvastatin >20 mg — bempedoic acid inhibits OATP1B1/B3 and increases simvastatin exposure; limit simvastatin to 20 mg; prefer rosuvastatin/atorvastatin
  • Pravastatin >40 mg — similar transporter inhibition; limit dose
  • Ciclosporin — significant increase in bempedoic acid exposure; avoid combination

Monitoring

  • LDL-C (at 4-8 weeks)
  • Uric acid (baseline and 3-monthly)
  • LFTs (baseline, at 3 months)
  • Creatinine (may rise slightly — benign)
  • Tendon symptoms (each visit)

Reference: BNFc; BNF 90; CLEAR trial (Nissen et al. NEJM 2023); NICE TA898; MHRA SPC Nilemdo/Nustendi; ESC/EAS Dyslipidaemia 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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