Drug updated on 4/29/2024
| 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).
Summary
- Bempedoic acid (Nexletol) 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.
- A total of 10 systematic reviews/meta-analyses were reviewed, providing insights into the efficacy and safety profile of bempedoic acid in patients requiring lipid-lowering therapy.
- The combination therapies involving bempedoic acid have shown significant reductions in low-density lipoprotein cholesterol (LDL-C), total cholesterol, non-high-density lipoprotein cholesterol, apolipoprotein B, and hsCRP levels compared to standard treatments alone among high-risk cardiovascular patients including those intolerant to statins.
- In terms of safety considerations for prescribing decisions, while bempedoic acid has been associated with a lower risk of new-onset diabetes mellitus than controls; it also showed increased risks related to discontinuation due to adverse effects such as elevated serum uric acid level, liver enzymes elevation and creatine kinase increase which necessitates regular monitoring during its use.
- Despite these side effects observed across studies included in this review; overall evidence suggests that bempedoic acid provides a well-tolerated therapeutic option for lipid lowering especially when combined with other drugs like ezetimibe or statins among hyperlipidemic patients failing on maximum tolerated doses or intolerant individuals respectively.
- Further long-term trials are recommended by researchers given the relatively small number involved so far along with short-to-middle term duration natured ones currently available, aiming at exploring more about its longer-term safety besides confirming current findings regarding effectiveness against hypercholesterolemia particularly within different patient subgroups.
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 |