ATP-citrate lyase inhibitor (lipid-lowering) Pregnancy: Contraindicated during pregnancy - bempedoic acid 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. Use during breast-feeding may be considered, weighing the benefit of breast-feeding for the child against the benefit of therapy for the woman.

Bempedoic acid

Brand names: Nilemdo

Bempedoic acid is an oral lipid-lowering agent used to reduce LDL-cholesterol, either alone or with a statin and/or ezetimibe, in patients with hypercholesterolaemia or mixed dyslipidaemia.

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: 180 mg once daily (one film-coated tablet)

Route: Oral - taken with or without food; the tablet should be swallowed whole

Frequency: Once daily

Source is the eMC SPC for Nilemdo 180 mg film-coated tablets. Concomitant simvastatin: when bempedoic acid is coadministered with simvastatin, 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 treatment goals on lower doses and when benefits are expected to outweigh the risks; simvastatin above 40 mg daily is contraindicated. Elderly: no dose adjustment necessary. Hepatic impairment: no dose adjustment necessary in mild or moderate impairment (Child-Pugh A or B); no data in severe impairment (Child-Pugh C) - periodic liver function tests should be considered. Liver function tests should be performed at initiation of therapy and treatment discontinued if a transaminase rise greater than 3 times the upper limit of normal persists. Discontinue if hyperuricaemia accompanied by symptoms of gout appears. Paediatric: safety and efficacy in children aged less than 18 years have not yet been established; no data available.

Dose adjustments

Renal

No dose adjustment is necessary in patients with mild or moderate renal impairment. Limited data are available in severe renal impairment (eGFR less than 30 mL/min/1.73 m2) and in end-stage renal disease on dialysis - additional monitoring for adverse reactions may be warranted.

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 bempedoic acid or to any of the excipients
Pregnancy
Concomitant use with simvastatin greater than 40 mg daily

Side effects

Hyperuricaemia (common, 3.8% in pivotal trials); gout (common, 1.4%)
Anaemia (common, 2.5%); haemoglobin decreased (uncommon)
Pain in extremity (common, 3.1%)
Aspartate aminotransferase increased (common); alanine aminotransferase increased and liver function test increased (uncommon)
Glomerular filtration rate decreased (common); blood creatinine and blood urea increased (uncommon)

Interactions

Simvastatin - limit to 20 mg daily (40 mg daily only in severe hypercholesterolaemia at high cardiovascular risk); doses above 40 mg daily are contraindicated. Myositis with CPK greater than 10 times ULN has rarely been reported with bempedoic acid plus background simvastatin 40 mg
Statins generally - bempedoic acid increases plasma concentrations of statins; monitor for adverse reactions associated with high-dose statins and advise patients to report unexplained muscle pain, tenderness or weakness. Discontinue bempedoic acid and the statin immediately if myopathy is confirmed (CPK greater than 10 times ULN)
Fibrates - concomitant administration resulted in increased triglycerides and decreased HDL-cholesterol in some patients; monitor HDL-cholesterol and triglycerides
(Interactions above are taken from the fetched sections 4.2, 4.3 and 4.4; the full section 4.5 was not retrieved in this bundle - verify against the complete SPC)

Clinical monograph

How it works

It is a prodrug that inhibits ATP-citrate lyase in the cholesterol biosynthesis pathway, upregulating LDL receptors and lowering circulating LDL-cholesterol.

Prescribing in practice

It can raise serum uric acid and may precipitate gout, so use with caution in patients with a history of gout or hyperuricaemia.
Tendon rupture has been reported, so consider discontinuation if tendinitis or tendon rupture occurs.
Activation occurs in the liver via an enzyme largely absent from skeletal muscle, which may account for a low incidence of muscle-related effects.

Monitoring

Monitor the lipid profile for response, and check uric acid and assess for gout symptoms where clinically indicated.

Counselling the patient

Report joint pain or swelling, which could indicate gout, and any tendon pain or swelling.
Continue dietary measures and any other cholesterol-lowering medicines alongside this treatment.

Evidence & guidelines

The CLEAR Outcomes trial demonstrated cardiovascular risk reduction with bempedoic acid in statin-intolerant patients.

Reference: NICE TA694; 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).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways