Drug updated on 5/17/2024
Dosage Form | Tablet (oral; 180 mg) |
Drug Class | Adenosine 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).
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Summary
- 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 Title | Year | Source |
---|---|---|
Nexletol (bempedoic acid) Prescribing Information. | 2024 | Esperion Therapeutics, Inc., Ann Arbor, MI |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
2022 ACC expert consensus decision pathway on the role of nonstatin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: a report of the American College of Cardiology solution set oversight committee. | 2022 | Journal of the American College of Cardiology |
VA/DoD clinical practice guideline for the management of dyslipidemia for cardiovascular risk reduction. | 2020 | Department of Veterans Affairs Department of Defense |