Bempedoic acid

(Nexletol®)

Bempedoic acid

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Drug updated on 5/17/2024

Dosage FormTablet (oral; 180 mg)
Drug ClassAdenosine triphosphate-citrate lyase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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.
  • Indicated 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).

Summary
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  • Bempedoic acid (Nexletol) is used to reduce the risk of myocardial infarction and coronary revascularization in adults unable to take recommended statin therapy, including those not using a statin with established cardiovascular disease or at high risk for a cardiovascular event. It is also employed as an adjunct to diet, in combination with other low-density lipoprotein cholesterol-lowering therapies, or alone when other LDL-C lowering therapy isn't possible.
  • Fifteen systemic reviews/meta-analyses focused on Nexletol's efficacy, safety profile, and comparative analysis with other lipid-lowering therapies for managing hypercholesterolemia and preventing cardiovascular disease events.
  • Compared to placebos and as an adjunct therapy, Bempedoic acid has shown significant reductions in LDL-C levels. When compared with drugs like statins, ezetimibe, and PCSK9 inhibitors, it presents itself as an effective option, especially among populations intolerant to statins or those not meeting their LDL-C goals solely through the use of statins.
  • Several analyses suggest that Bempedoic acid is associated with reduced risks of major adverse cardiovascular events such as non-fatal myocardial infarctions, highlighting its potential role in managing cardiovascular risks among patients unable to achieve lipid goals via other treatments.
  • Beyond modifying lipid levels, Bempedoic acid significantly reduces high-sensitivity C-reactive protein (hsCRP), a marker for inflammation, indicating additional benefits contributing towards its protective effects against heart diseases.
  • In terms of the safety profile, compared to other lipid-lowering therapies, Bempedoic acid shows favorable results concerning muscle-related adverse events, making it a suitable choice for patients intolerant towards statins. Additionally, there seems to be a lower incidence rate regarding new-onset diabetes, which makes this drug a considerable option for long-term treatment plans.
  • However, some studies have reported elevated uric acid levels leading to gout among patients treated with Bempedoic acid. Therefore, careful monitoring is advised for at-risk populations.
  • Bempedoic acid has shown effectiveness across various subgroup populations, including those with established atherosclerotic cardiovascular diseases, making it applicable broadly. It's particularly beneficial for statin-intolerant patients and those suffering from mixed hypercholesterolemia who aren't meeting their lipid-lowering goals through conventional therapies.

Product Monograph / Prescribing Information

Document TitleYearSource
Nexletol (bempedoic acid) Prescribing Information.2024Esperion Therapeutics, Inc., Ann Arbor, MI

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Effect of lipid-lowering therapies on C-reactive protein levels: a comprehensive meta-analysis of randomized controlled trials.2024Cardiovascular Research
Efficacy and safety of bempedoic acid lipid-lowering therapy: a systematic review and meta-analysis of randomized controlled trials.2023European Journal of Clinical Pharmacology
Untangling the relationship between bempedoic acid and gout: results from a systematic literature review.2023Frontiers in Cardiovascular Medicine
Safety and efficacy of bempedoic acid: a systematic review and meta-analysis of randomised controlled trials. 2023Cardiovascular Diabetology
Cardiovascular events in patients treated with bempedoic acid vs. placebo: systematic review and meta-analysis.2023European Heart Journal. Cardiovascular Pharmacotherapy
Network meta‐analysis of randomized trials evaluating the comparative efficacy of lipid‐lowering therapies added to maximally tolerated statins for the reduction of low‐density lipoprotein cholesterol. 2022Journal of the American Heart Association
Bempedoic acid’s use as an adjunct in lowering low-density lipoprotein cholesterol in patients with coronary artery disease: a systematic review.2022Cureus
Clinical efficacy and safety outcomes of bempedoic acid for LDL-C lowering therapy in patients at high cardiovascular risk: a systematic review and meta-analysis. 2022BMJ Open
Efficacy and safety of bempedoic acid for the treatment of hypercholesterolemia: a systematic review and meta-analysis.2020PLOS Medicine
Efficacy and safety of bempedoic acid for prevention of cardiovascular events and diabetes: a systematic review and meta-analysis.2020Cardiovascular Diabetology
Efficacy and safety of bempedoic acid in patients with hypercholesterolemia: systematic review and meta‐analysis of randomized controlled trials.2020Journal of the American Heart Association
Efficacy and safety of bempedoic acid alone or combining with other lipid lowering therapies in hypercholesterolemic patients: a meta-analysis of randomized controlled trials.2020BMC Pharmacology and Toxicology
Efficacy and safety of bempedoic acid in patients with hypercholesterolemia: a systematic review and meta-analysis of randomized controlled trials.2020European Journal of Preventive Cardiology
Bempedoic acid and ezetimibe for the treatment of hypercholesterolemia: a systematic review and meta-analysis of randomized phase II/III trials.2020Clinical Drug Investigation
Association of bempedoic acid administration with atherogenic lipid levels in phase 3 randomized clinical trials of patients with hypercholesterolemia.2020JAMA Cardiology

Clinical Practice Guidelines