From the Guidelines
Bempedoic acid (Nexletol) is indicated as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL cholesterol. The standard dosage is 180 mg taken orally once daily, with or without food. Bempedoic acid works by inhibiting ATP citrate lyase, an enzyme involved in cholesterol synthesis upstream from HMG-CoA reductase (the target of statins), thereby reducing LDL cholesterol production in the liver. This medication is particularly useful for patients who cannot tolerate high-intensity statin therapy due to muscle-related side effects or who have not achieved target LDL levels despite maximally tolerated statin therapy. Bempedoic acid can lower LDL cholesterol by approximately 23% when added to statin therapy, as suggested by a pooled analysis 1. It should not be used as a first-line therapy but rather as part of a comprehensive lipid management approach. Patients should be advised that bempedoic acid may increase serum uric acid levels and the risk of tendon rupture, and regular monitoring of lipid levels is recommended to assess treatment efficacy. Key considerations for its use include:
- FDA-approved indication for adults with ASCVD or HeFH as adjunct to diet and maximally tolerated statin therapy 1
- Dose of 180 mg orally once daily, with or without food
- Mean % reduction in LDL-C of approximately 17%-18% when combined with statin therapy 1
- Potential for increased serum uric acid and risk of tendon rupture, necessitating careful monitoring and patient education 1
From the FDA Drug Label
NEXLETOL, an adenosine triphosphate-citrate lyase (ACL) inhibitor, is indicated: To reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with: established cardiovascular disease (CVD), or a high risk for a CVD event but without established CVD. As an adjunct to diet, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).
The indications for bempedoic acid (Nexletol) use in adults with hyperlipidemia are:
- To reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy with established cardiovascular disease (CVD) or a high risk for a CVD event but without established CVD.
- As an adjunct to diet, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) 2.
From the Research
Indications for Bempedoic Acid Use
Bempedoic acid, also known by its brand name Nexletol, is indicated for use in adults with hyperlipidemia. The specific indications include:
- Heterozygous familial hypercholesterolemia (HeFH) 3, 4, 5, 6, 7
- Atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C) 3, 4, 5, 7
- Primary hypercholesterolemia (heterozygous familial and nonfamilial) or mixed dyslipidemia 3
- Adults with hypercholesterolemia who are statin intolerant or require additional LDL-C lowering 4, 5, 6, 7
Patient Populations
Bempedoic acid may be particularly beneficial for:
- Patients with HeFH who require additional LDL-C lowering 5, 6
- Patients who are statin intolerant or unable to take adequate doses of statins 4, 5, 6, 7
- Patients with ASCVD who require additional LDL-C lowering 3, 4, 5, 7
Dosage and Administration
Bempedoic acid is administered orally at a dosage of 180 mg once daily 3, 7. It can be used as an adjunct to diet and maximally tolerated statin therapy, or as an alternative to statin therapy in patients who are statin intolerant 3, 4, 5, 6, 7.