Drug updated on 12/11/2024
Dosage Form | Tablet (oral; bempedoic acid/ezetimibe: 180 mg/10 mg) |
Drug Class | Adenosine triphosphate citrate lyase (ACL) inhibitors and dietary cholesterol absorption inhibitors. |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)
- 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
Latest News
Summary
- This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
- Bempedoic acid, especially in combination with ezetimibe, significantly reduced low-density lipoprotein cholesterol (LDL-C) levels, total cholesterol, non-high-density lipoprotein (non-HDL) cholesterol, and high-sensitivity C-reactive protein (hs-CRP) levels in high-risk patients, including those with hypercholesterolemia, established Atherosclerotic Cardiovascular Disease (ASCVD), and statin-intolerant individuals.
- Non-statin regimens demonstrated varying effectiveness, with evolocumab and alirocumab showing the greatest LDL-C reductions, followed by inclisiran, the bempedoic acid/ezetimibe fixed-dose combination, and monotherapies of ezetimibe and bempedoic acid.
- Bempedoic acid independently reduced hsCRP levels, an inflammatory marker, with additional reductions observed when combined with ezetimibe.
- Bempedoic acid use showed no adverse side effects except for potential increases in serum uric acid levels, with monitoring recommended for patients due to this observed rise. There was a trend of higher muscle-related adverse events when bempedoic acid was combined with statins, consistent with those observed with statin monotherapy.
- The combination of bempedoic acid and ezetimibe was associated with a non-significant increase in drug-related and overall adverse events, with a noted potential increased risk of muscle-related adverse events when used with statins.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Nexlizet (bempedoic acid and ezetimibe) 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 |