Bempedoic Acid
In brief
- Bempedoic acid (Nilemdo, or combined with ezetimibe as Nustendi) is a prescription-only medicine (POM) in the UK and should be obtained with a valid prescription.
- Bempedoic acid is used to lower LDL‑cholesterol in primary hypercholesterolaemia and mixed dyslipidaemia, as an adjunct to diet and maximally tolerated statin therapy or for statin‑intolerant patients; it works as an ATP citrate lyase (ACL) inhibitor, reducing cholesterol synthesis upstream of HMG‑CoA reductase.
- The usual dose for adults is 180 mg orally once daily; the fixed‑dose combination with ezetimibe is 180 mg/10 mg once daily.
- The form of administration is a film‑coated oral tablet, taken once daily with or without food.
- LDL‑C lowering can begin within 2–4 weeks, with reassessment typically at 4–12 weeks.
- Duration of action is maintained with once‑daily dosing — LDL‑C reductions persist while treatment is continued, with steady‑state pharmacodynamic effects reached within days to weeks and maximal clinical effect by around 12 weeks.
- Avoid excessive alcohol while being treated; there is no specific alcohol contraindication but alcohol may worsen liver function or interact with comorbidities — bempedoic acid is contraindicated in pregnancy and breastfeeding.
- The most common side effects include increased uric acid/hyperuricaemia (and gout risk), muscle spasms, back and limb pain, upper respiratory tract infections, abdominal pain, diarrhoea, fatigue and elevations in liver enzymes.
- Would you like to try bempedoic acid without a prescription?
Basic bempedoic acid information
- INN (international nonproprietary name): Bempedoic acid
- Brand names available in the United Kingdom: Nilemdo (bempedoic acid 180 mg); Nustendi (bempedoic acid 180 mg/ezetimibe 10 mg)
- ATC code: C10AX15
- Forms and dosages: Film-coated tablet 180 mg (monotherapy); film-coated tablet 180 mg/10 mg (fixed combination with ezetimibe)
- Manufacturers in the United Kingdom: Daiichi Sankyo (Nilemdo and Nustendi)
- Registration status in the United Kingdom: Prescription-only medicine (POM)
- OTC / Rx classification: Prescription-only medicine (POM)
Legal status and availability in the UK
Bempedoic acid is a prescription-only medicine (POM) in the UK.
In our online pharmacy, bempedoic acid is available without a prescription, with discreet delivery to the United Kingdom in 9–21 days.
Mechanism of action
ACL inhibition compared with statins
How does bempedoic acid lower cholesterol compared with statins and ezetimibe?
Bempedoic acid inhibits ATP citrate lyase (ACL), an enzyme upstream of HMG‑CoA reductase in the hepatic cholesterol synthesis pathway.
This reduces hepatic cholesterol production and upregulates LDL receptors to clear LDL‑C from the blood.
Statins inhibit HMG‑CoA reductase directly, one step downstream from ACL inhibition.
Ezetimibe reduces intestinal cholesterol absorption, acting at a different site entirely.
Mechanism flowchart
Dietary/Endogenous Citrate → ACL (inhibited by bempedoic acid) → ↓ Acetyl‑CoA for cholesterol synthesis → ↓ Hepatic cholesterol → ↑ LDL Receptor Expression → ↓ LDL‑C.
HMG‑CoA Reductase (inhibited by statins) → Direct reduction in cholesterol synthesis.
NPC1L1 Transporter (inhibited by ezetimibe) → ↓ Intestinal cholesterol absorption.
Key term definitions
- ACL: ATP citrate lyase, an enzyme in hepatic cholesterol synthesis.
- LDL‑C: Low‑density lipoprotein cholesterol, the primary target for reduction.
Because bempedoic acid is activated in the liver and remains inactive in skeletal muscle, it may have lower direct muscle exposure than statins, which helps explain its role for many statin‑intolerant patients.
Licensed indications and clinical positioning
Who is suitable and when to prescribe
Who should be considered for bempedoic acid in primary care?
Licensed indications include adult patients with primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet and maximally tolerated statin therapy.
It is also indicated for adults who are statin‑intolerant and require LDL‑C reduction.
The standard adult dose is 180 mg orally once daily, with a fixed combination available at 180 mg/10 mg for added effect from ezetimibe.
Treatment is intended to be chronic, with LDL‑C reassessment usually at 4–12 weeks after starting therapy.
Positioning versus other agents: ezetimibe is often the first oral add‑on for modest additional LDL‑C lowering, while PCSK9 inhibitors are injectable options reserved for greater reduction or when oral therapy is insufficient or unsuitable.
| Indication | Place in therapy |
|---|---|
| Adjunct to maximally tolerated statin | Add‑on oral option before injectables |
| Statin intolerance | Oral alternative to try for LDL‑C lowering |
Treatment pathway
Maximally tolerated statin → add ezetimibe → add bempedoic acid (or switch to the combination) → consider a PCSK9 inhibitor if the target is not met.
Formulations and strengths
Nilemdo (monotherapy) is supplied as a 180 mg film-coated tablet, and the fixed combination with ezetimibe (Nustendi) is a 180 mg/10 mg film-coated tablet.
| Brand | Strength | Manufacturer |
|---|---|---|
| Nilemdo | 180 mg tablet | Daiichi Sankyo |
| Nustendi | 180 mg/10 mg tablet | Daiichi Sankyo |
Dosing, administration, missed dose and overdose
Directions for use
Adult dosing: take one 180 mg tablet orally once daily for monotherapy; fixed combination tablets are 180 mg/10 mg once daily.
Tablets may be taken with or without food according to the product information.
If a dose is missed, take it as soon as remembered unless the next dose is due soon; do not double the next dose.
In case of overdose, provide supportive care and monitor for adverse effects, especially muscle symptoms; there is no specific antidote.
| Product | Dosage |
|---|---|
| Monotherapy | 180 mg once daily |
| Fixed combination | 180 mg/10 mg once daily |
Safety profile, monitoring and counselling points
What to monitor and when to refer
Which tests and checks should be routine when supplying bempedoic acid?
Common safety signals include hyperuricaemia, muscle spasms, back and limb pain, upper respiratory symptoms, gastrointestinal upset, fatigue and raised hepatic enzymes.
Absolute contraindications comprise known hypersensitivity and pregnancy or breastfeeding.
Baseline tests recommended: lipid panel and liver function tests, with serum uric acid if there is a history of gout.
Repeat assessment of LDL‑C and safety monitoring should occur around 4–12 weeks after starting treatment.
Refer urgently for severe muscle weakness, signs of tendon rupture, or marked liver enzyme elevations.
Patients should be aware of the gout risk, stay hydrated, report joint pain, avoid the medicine in pregnancy and seek urgent review for severe muscle or tendon symptoms.
Contraindications, cautions and drug interactions
Who needs extra care and what to avoid
Which patients require caution or are contraindicated?
Absolute contraindications from the product data are hypersensitivity to bempedoic acid or its excipients, and pregnancy or breastfeeding.
Cautions include severe renal impairment, significant hepatic impairment, a history of gout or hyperuricaemia, and prior tendon disorders.
Drug interactions should be checked against up‑to‑date local resources such as the BNF and MHRA advisories.
When combining with other lipid‑lowering agents, monitor for additive effects and ensure prescribers are aware of the full regimen.
| Risk area | Action |
|---|---|
| Gout / hyperuricaemia | Check uric acid baseline; advise hydration; inform prescriber if levels rise |
| Renal / hepatic impairment | Use caution; consider specialist advice for severe impairment |
Clinical efficacy
Evidence in brief
How effective is bempedoic acid in lowering LDL‑C in practice?
Regulatory reviews and clinical trials supported approval for LDL‑C lowering as an adjunct or alternative therapy in adults with hypercholesterolaemia or mixed dyslipidaemia.
The fixed combination with ezetimibe provides greater LDL‑C lowering than monotherapy based on product data and regulatory assessment.
Position bempedoic acid as an oral option that typically offers modest additional LDL‑C reduction compared with ezetimibe and less reduction than PCSK9 biologics, which are injectable.
| Oral option | Typical role |
|---|---|
| Ezetimibe | First oral add‑on for modest LDL‑C lowering |
| Bempedoic acid | Oral adjunct or alternative for statin intolerance |
| PCSK9 inhibitors | Greater LDL‑C reduction; injectable |
Monitoring, follow‑up and switching strategies in practice
Timelines, labs and how to escalate therapy
What is a practical follow‑up schedule after starting bempedoic acid?
Baseline tests should include a lipid profile, liver function tests and renal function, with serum uric acid if the patient has gout history.
Reassess LDL‑C and enquire about side effects at 4–12 weeks after initiation or dose change.
If LDL‑C targets are not met, first check adherence, drug interactions and correct dosing.
Consider adding ezetimibe or switching to the fixed‑dose combination before escalation to PCSK9 inhibitors, subject to local commissioning rules.
For statin‑intolerant patients, document intolerance and discuss re‑challenge where clinically appropriate.
Special populations: elderly, renal/hepatic impairment, pregnancy
Dosing guidance and contraindications
Are dose adjustments required for special populations?
Bempedoic acid is not approved for use in children due to lack of established safety and efficacy data.
Elderly patients generally require no dose adjustment and receive the same adult dose unless comorbidities dictate otherwise.
No dose adjustment is needed for mild to moderate renal impairment (eGFR ≥30 mL/min/1.73 m²), but caution is advised in severe impairment where data are limited.
For hepatic impairment, use caution and monitor in moderate disease and avoid use in severe hepatic impairment.
Pregnancy and breastfeeding are contraindicated due to insufficient safety data.
| Population | Recommendation |
|---|---|
| Children | Not approved |
| Elderly | No routine adjustment |
| Renal impairment | No adjustment for mild/moderate; caution if severe |
| Pregnancy / Breastfeeding | Contraindicated |
Effective contraception is advised for women of childbearing potential where appropriate.
Storage
Store at room temperature between 15–30°C and protect from moisture in the original packaging.
Delivery across the United Kingdom
| City | Region | Delivery time |
|---|---|---|
| London | Greater London | 9–21 days |
| Birmingham | West Midlands | 9–21 days |
| Manchester | Greater Manchester | 9–21 days |
| Glasgow | Scotland | 9–21 days |
| Leeds | West Yorkshire | 9–21 days |
| Edinburgh | Scotland | 9–21 days |
| Bristol | South West | 9–21 days |
| Newcastle | North East | 9–21 days |
| Sheffield | South Yorkshire | 9–21 days |
| Liverpool | Merseyside | 9–21 days |
| Cardiff | Wales | 9–21 days |
| Belfast | Northern Ireland | 9–21 days |
| Norwich | East of England | 9–21 days |
| Exeter | South West | 9–21 days |