Drug updated on 4/29/2024
| Dosage Form | Tablet (oral; bempedoic acid/ezetimibe: 180 mg/10 mg) |
| Drug Class | Adenosine triphosphate citrate lyase inhibitors and dietary cholesterol absorption inhibitor |
| 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.
Summary
- Bempedoic acid and ezetimibe (Nexlizet) is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
- The drug has been found effective in significantly reducing low-density lipoprotein cholesterol (LDL-C), total cholesterol, non-high-density lipoprotein cholesterol, apolipoprotein B levels, and high sensitivity C-reactive protein levels in patients with hypercholesterolemia or established atherosclerotic cardiovascular disease.
- In comparison to other drugs such as evolocumab and alirocumab when added to maximally tolerated statins, bempedoic acid/ezetimibe fixed-dose combination was less efficacious but still showed significant reduction in LDL-C from baseline versus placebo regardless of background therapy.
- A safety analysis revealed that while bempedoic acid did not increase the risk of overall adverse events compared to placebo group, it was associated with increased risks including discontinuation due to side effects like elevated serum uric acid level, liver enzymes elevation and creatine kinase elevation; however it also decreased the risk for new onset or worsening diabetes.
- This information is derived from 7 systematic reviews/meta-analyses on randomized controlled trials involving Nexlizet's use among patients requiring further lowering of their LDL-C despite being on maximum tolerable doses of statin therapies.
- While these studies provide valuable insights into Nexlizet's efficacy profile relative to other lipid-lowering agents along with its safety considerations over short-to-mid term usage periods, more long-term studies are needed for comprehensive understanding about its longer-term safety implications especially concerning muscle-related adverse events observed during combination administration alongside statins.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Nexlizet (bempedoic acid and ezetimibe) Prescribing Information. | 2021 | 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 |