Bempedoic acid and ezetimibe

(Nexlizet®)

Nexlizet®

Drug updated on 12/11/2024

Dosage FormTablet (oral; bempedoic acid/ezetimibe: 180 mg/10 mg)
Drug ClassAdenosine 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

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Summary
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  • 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 TitleYearSource
Nexlizet (bempedoic acid and ezetimibe) Prescribing Information.2024Esperion Therapeutics, Inc., Ann Arbor, MI

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines