ATP Citrate Lyase (ACL) Inhibitor Pregnancy: Contraindicated during pregnancy — 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 may be considered (relative infant dose approximately 0.5%), weighing benefits against therapy.

Bempedoic Acid

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

Bempedoic acid is an oral lipid-lowering agent used to reduce LDL-cholesterol, typically as add-on therapy or where statins are not tolerated or insufficient, often combined with ezetimibe.

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 (one film-coated tablet)

Route: Oral — swallow the tablet whole, with or without food

Frequency: Once daily

Source SPC is Nilemdo 180 mg film-coated tablets. Concomitant simvastatin: limit simvastatin to 20 mg daily (or 40 mg daily for patients with severe hypercholesterolaemia and high cardiovascular risk who have not reached treatment goals on lower doses and where benefits are expected to outweigh risks); simvastatin >40 mg daily is contraindicated. Elderly: no dose adjustment necessary. Hepatic impairment: no dose adjustment in mild or moderate impairment (Child-Pugh A or B); no data in severe impairment (Child-Pugh C) — consider periodic liver function tests. Liver function tests should be performed at initiation; discontinue if transaminase increase >3x ULN persists. Discontinue if hyperuricaemia accompanied by symptoms of gout appears. Paediatric population: safety and efficacy in children aged under 18 years have not yet been established; no data available.

Dose adjustments

Renal

No dose adjustment is necessary in mild or moderate renal impairment. 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.

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 substance or to any of the excipients
Pregnancy
Concomitant use with simvastatin >40 mg daily

Side effects

Hyperuricaemia (3.8%) and gout (1.4%)
Pain in extremity (3.1%)
Anaemia (2.5%)
Elevated liver enzymes — aspartate aminotransferase increased (common), alanine aminotransferase increased (uncommon)
Glomerular filtration rate decreased (common); muscle spasms, diarrhoea and nausea led to discontinuation more often than placebo

Interactions

Simvastatin — bempedoic acid increases plasma statin concentrations; limit simvastatin to 20 mg daily (40 mg daily in defined high-risk patients); doses >40 mg daily are contraindicated
Statins generally — monitor for adverse reactions associated with high statin doses; discontinue bempedoic acid and the statin immediately if myopathy is confirmed by CPK >10x ULN
Fibrates — concomitant administration resulted in increased triglycerides and decreased HDL-C in some patients; monitor HDL-C and triglycerides

Clinical monograph

How it works

It is a prodrug activated in the liver that inhibits ATP-citrate lyase, an enzyme upstream of HMG-CoA reductase in the cholesterol synthesis pathway, reducing hepatic cholesterol production and increasing LDL clearance.

Prescribing in practice

It can raise serum uric acid and may precipitate or worsen gout, so use caution in patients with a history of gout or hyperuricaemia.
Cases of tendon rupture have been reported, and treatment should be discontinued if tendon rupture occurs.
Because activation is largely confined to the liver rather than muscle, it is a useful option in statin intolerance, though lipid response should still be assessed.

Monitoring

Monitor the lipid profile for response and review uric acid and gout symptoms, stopping treatment if tendon injury is suspected.

Counselling the patient

It is taken once daily, usually with another cholesterol-lowering medicine.
Report painful or swollen joints suggesting gout, or tendon pain or swelling.
Keep up dietary and lifestyle measures alongside it.

Evidence & guidelines

Bempedoic acid lowers LDL-cholesterol and has cardiovascular outcome evidence in statin-intolerant patients, and NICE supports its use in defined add-on scenarios.

Reference: CLEAR trial (Nissen et al. NEJM 2023); NICE TA898; MHRA SPC Nilemdo/Nustendi; ESC/EAS Dyslipidaemia Guidelines (2019); 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