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ATP-citrate lyase inhibitor + cholesterol absorption inhibitor Pregnancy: Contraindicated during pregnancy - there are no or limited data in pregnant women, animal studies with bempedoic acid have shown reproductive toxicity, and the product may cause foetal harm. Discontinue prior to conception or as soon as pregnancy is planned or recognised. Women of childbearing potential should use effective contraception during treatment. Breast-feeding: bempedoic acid and ezetimibe and their active metabolites are excreted in human milk in very low amounts and no effects on breastfed infants are anticipated at therapeutic doses - use during breast-feeding may be considered, weighing the benefit of breast-feeding for the child against the benefit of therapy for the woman (eMC 4.6).

Bempedoic acid with ezetimibe

Brand names: Nustendi

A fixed-dose oral combination of bempedoic acid and ezetimibe used as an adjunct to diet to lower LDL-cholesterol, particularly where statins are not tolerated or do not achieve target.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: One film-coated tablet of 180 mg/10 mg (bempedoic acid 180 mg / ezetimibe 10 mg)
Route: Oral - swallow the tablet whole, with or without food
Frequency: Once daily
eMC SPC 4.2 (Nustendi 180 mg/10 mg film-coated tablets). Co-administration with bile acid sequestrants: dosing should occur either at least 2 hours before or at least 4 hours after administration of the bile acid sequestrant. Concomitant simvastatin therapy: the simvastatin dose should be limited to 20 mg daily (or 40 mg daily for patients with severe hypercholesterolaemia and high risk for cardiovascular complications who have not achieved their treatment goals on lower doses and where the benefits are expected to outweigh the potential risks). ELDERLY: no dose adjustment is necessary. RENAL IMPAIRMENT: no dose adjustment is necessary in mild or moderate renal impairment; there are limited data in severe renal impairment (eGFR < 30 mL/min/1.73 m2) and in end-stage renal disease on dialysis, where additional monitoring for adverse reactions may be warranted. HEPATIC IMPAIRMENT: no dose adjustment in mild impairment (Child-Pugh A); treatment is not recommended in moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment due to the unknown effects of increased exposure to ezetimibe. PAEDIATRIC: safety and efficacy in children aged less than 18 years have not been established and no data are available - no paediatric dose is stated; refer to a children's formulary. NOTE: eMC 4.5 was not captured in this bundle - the interaction list below is drawn from SPC 4.2/4.3/4.4 only.

Dose adjustments

Renal

No dose adjustment is necessary in patients with mild or moderate renal impairment. There are limited data in severe renal impairment (eGFR < 30 mL/min/1.73 m2) and in end-stage renal disease on dialysis; additional monitoring for adverse reactions may be warranted in these patients (eMC 4.2).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substances or to any of the excipients
  • Pregnancy
  • Concomitant use with simvastatin > 40 mg daily
  • When co-administered with a statin: active liver disease or unexplained persistent elevations in serum transaminases
  • When co-administered with a statin, refer also to the summary of product characteristics for that particular statin

Side effects

  • Hyperuricaemia (4.7%) - common; gout - common with bempedoic acid
  • Constipation (4.7%), diarrhoea, abdominal pain, nausea, dry mouth, flatulence, gastritis - common
  • Back pain, muscle spasms, myalgia, pain in extremity, arthralgia - common
  • Dizziness and headache - common; fatigue and asthenia - common
  • Liver function test increased (AST increased common, ALT increased uncommon); blood creatinine increased and glomerular filtration rate decreased - common
  • Anaemia / decreased haemoglobin, decreased appetite, hypertension, cough - common

Interactions

  • Statins - bempedoic acid increases plasma concentrations of statins, increasing the risk of myopathy and rhabdomyolysis; monitor patients for adverse reactions associated with high statin doses and discontinue both immediately if myopathy is confirmed by a CPK level > 10x ULN
  • Simvastatin - limit the simvastatin dose to 20 mg daily (or 40 mg daily in defined high-risk patients); doses of simvastatin > 40 mg daily are contraindicated with this combination
  • Bile acid sequestrants - separate dosing, either at least 2 hours before or at least 4 hours after the sequestrant
  • NOTE: eMC 4.5 was not captured in this bundle - clinician to review the full 4.5 before publication.

Clinical monograph

How it works

Bempedoic acid inhibits ATP-citrate lyase upstream of cholesterol synthesis, upregulating LDL receptors, while ezetimibe inhibits the intestinal cholesterol transporter NPC1L1 to reduce cholesterol absorption; together they lower circulating LDL-cholesterol.

Prescribing in practice

  • Bempedoic acid can raise serum uric acid and precipitate gout and has been associated with tendon rupture, so review patients with hyperuricaemia, gout or tendon disorders.
  • Avoid concurrent high-intensity simvastatin and use caution with statins generally, as bempedoic acid increases statin exposure and the risk of myopathy.
  • It is an option for statin intolerance or inadequate response, not a routine first-line lipid-lowering choice.

Monitoring

Monitor lipid profile to assess response, with review of uric acid and gout symptoms where relevant.

Counselling the patient

  • Report joint pain or swelling suggestive of gout, or tendon pain or swelling.
  • Continue dietary and lifestyle measures alongside the tablet.
  • Tell your prescriber about any statin you are also taking.

Evidence & guidelines

NICE recommends bempedoic acid with ezetimibe as an option for primary hypercholesterolaemia or mixed dyslipidaemia when statins are contraindicated or not tolerated, supported by cardiovascular outcome data for bempedoic acid.

Reference: NICE TA729; ESC/EAS; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.