Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 180 mg) |
| Drug Class | Adenosine triphosphate-citrate lyase (ACL) 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).
Latest News
Summary
- This summary is based on the review of 18 systematic review(s)/meta-analysis(es). [1-18]
- Bempedoic acid significantly reduces Low-Density Lipoprotein (LDL)-C levels across multiple studies, with a least-square mean percentage change of -24.34% (95% confidence interval (CI): -27.80 to -20.88, P < 0.0001) in one study, and similar reductions ranging from -22.94% to -23.16% in others.
- Bempedoic acid ranked first in reducing the risk of composite cardiovascular outcomes, with a relative risk of 0.75 (95% credible interval (CrI): 0.57-0.99). It also reduced major adverse cardiovascular events (odds ratio (OR) 0.86, 95% CI 0.79-0.95).
- Bempedoic acid significantly lowered other lipid parameters, including total cholesterol, non-High-Density Lipoprotein (HDL)-C, and high-sensitivity C-reactive protein, with reductions such as -10.9% for total cholesterol and -13.2% for high-sensitivity C-Reactive Protein (CRP) in one study.
- In statin-intolerant patients, bempedoic acid showed significant LDL-C reductions, with a mean LDL-C level decrease of -23.0% compared to 1.5% in the placebo group, and was associated with lower risks of cardiovascular events.
- Bempedoic acid was generally well tolerated and did not significantly increase the overall risk of adverse events compared to placebo (OR 1.02, 95% CI 0.88 to 1.18), suggesting an acceptable safety profile.
- There was an increased risk of specific adverse events, including gout (OR 1.55, 95% CI 1.27-1.90) and treatment-related discontinuations (OR 1.44, 95% CI 1.14 to 1.82). Other reported side effects included elevated serum uric acid, liver enzymes, and creatine kinase levels.
- Study findings also indicated a higher incidence of gout (1.4% vs 0.4%) and increased blood uric acid levels (2.1% vs 0.5%) in the bempedoic acid group compared to placebo, as well as a slightly elevated risk of muscle-related adverse events when combined with statins.
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 |
|---|---|---|
| Bempedoic acid in the management of lipid disorders and cardiovascular risk. 2023 position paper of the International Lipid Expert Panel (ILEP). | 2023 | Progress in Cardiovascular Diseases |
| 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 |