Ácido bempedoico

ATC code

C10AX15

Therapeutic class

Lipid modifying agent · ATP-citrate lyase (ACL) inhibitor

Forms

film-coated tablet

Brand names

Nilemdo (ES) · Nexletol (US)

Overall confidence

medium

Regulatory sources consulted

Primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet, in combination with a statin or a statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin.
Primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet, as monotherapy or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Major warning · Risk of myopathy with concomitant use of statins. Monitor for signs and symptoms of muscle pain, tenderness, or weakness. — AEMPS CIMA
Increase in uric acid (hyperuricemia). May lead to or exacerbate gout. — AEMPS CIMA
Major warning · Risk of tendon rupture, especially in patients >60 years of age, with renal failure, or on corticosteroids or fluoroquinolones. — AEMPS CIMA

HighSimvastatinC10AA01
Mechanism: Bempedoic acid inhibits OATP1B1, increasing simvastatin exposure and the risk of myopathy.
Recommendation: Concomitant use with simvastatin > 40 mg/day is contraindicated. For simvastatin doses ≤ 40 mg/day, use with caution and monitor for myopathy.
AEMPS CIMA
ModeratePravastatinC10AA03
Mechanism: Bempedoic acid inhibits OATP1B1, increasing pravastatin exposure and the risk of myopathy.
Recommendation: Avoid concomitant use. If necessary, do not exceed pravastatin 40 mg/day and monitor for myopathy.
AEMPS CIMA

hyperuricemia · pain in extremity · anemia · gout

tendon rupture · myopathy · elevated transaminases

FDA category: X

Contraindicated during pregnancy and lactation due to the mechanism of action (inhibition of cholesterol synthesis) and the potential for fetal harm.

Cutting-edge lipid-lowering pharmacological therapies: Improving lipid control beyond statins.
Capuozzo M, et al. · Hipertens Riesgo Vasc · 2025 · Relevance 5/5
Revisión que posiciona al ácido bempedoico, un inhibidor de la ATP citrato liasa, como una alternativa prometedora para pacientes con intolerancia a las estatinas. Actúa en un punto anterior a las estatinas en la vía de síntesis del colesterol, ofreciendo una opción potencialmente más segura en este grupo de pacientes. El artículo lo compara con otras terapias novedosas como los inhibidores de PCSK9.
[Practical approach to the patient with hypercholesterolemia in Spain. SEMERGEN position statement].
Cinza-Sanjurjo S, et al. · Semergen · 2025 · Relevance 4/5
Documento de posicionamiento de SEMERGEN que revisa las opciones de tratamiento hipolipemiante, incluyendo las terapias más recientes. Subraya la necesidad de nuevas herramientas para alcanzar los objetivos de C-LDL, dado que las cifras de control actuales son bajas, y proporciona un enfoque práctico para el manejo de la hipercolesterolemia en diferentes subgrupos de pacientes.