Bempedoic acid and ezetimibe

(Nexlizet®)

Nexlizet®

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Drug updated on 5/17/2024

Dosage FormTablet (oral; bempedoic acid/ezetimibe: 180 mg/10 mg)
Drug ClassAdenosine triphosphate citrate lyase (ACL) inhibitor 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
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  • Bempedoic acid and ezetimibe (Nexlizet) is recommended as an addition 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. It also helps reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to use recommended statin therapy.
  • Seven systematic reviews/meta-analyses provided a detailed comparison of Nexlizet's safety and effectiveness relative to other lipid-lowering therapies.
  • Nexlizet is effective across a range of patient populations such as those currently using statin therapy, statin-intolerant individuals, and those with or at high risk of atherosclerotic cardiovascular disease. For individuals unable to achieve LDL-C targets with statins or those at elevated cardiovascular risk, Nexlizet is a beneficial adjunct therapy significantly reducing LDL-C levels.
  • In terms of the safety profile, the combination of bempedoic acid and ezetimibe was generally well-tolerated by individuals. The adverse effects noted mainly included increased risks of hyperuricemia, which could lead to gout; less commonly, there were cases involving elevated liver enzymes and creatine kinase levels.
  • Compared against placebo/no treatment groups during trials, it showed a substantial reduction in LDL-C, total cholesterol, Apo-B, and high-sensitivity C-reactive protein levels, confirming its efficacy in lipid management. While compared to non-statin therapies like PCSK9 inhibitors and inclisiran, it demonstrated superior efficacy when added onto existing treatments but still ranked among the most effective regimens available today.
  • The fixed-dose combination specifically yielded significant improvements over mono-drug options, underscoring the synergistic benefits of combining these two agents together. This makes it a suitable choice for various patient populations, including those suffering from heterozygous familial hypercholesterolemia and individuals at high risk of cardiovascular events due to elevated cholesterol levels.

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