Bempedoic acid – a new drug in lipid-lowering therapy

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Abstract

The clinical significance of lipid-lowering therapy in reducing the risk of atherosclerotic cardiovascular disease (CVD) and mortality has been proven. However, the achievement of target levels of cholesterol and its fractions in real practice is not ensured, there are problems with the tolerability of standard drugs (statins), often the use of additional lipid-lowering agents (ezetimibe, PCSK9 inhibitors) is required. In February 2020, the FDA approved a new drug, bempedoic acid (BA), recommended in the US and the European Union (EU) as an adjuvant to maximally tolerated statin therapy to lower low-density lipoprotein cholesterol in patients with atherosclerotic CVD and familial hypercholesterolemia, as well as in cases of intolerance or contraindications to the use of statins or in combination with ezetinib. The article presents data on the mechanism of action and clinical pharmacology of the drug, the results of 2nd and 3rd phase clinical trials (a series of CLEAR studies) to assess the safety and lipid-lowering efficacy in different categories of patients and modern meta-analyzes, as well as the results of a recent large study CLEAR Outcomes to assess major cardiovascular outcomes with BA. The place of BA in lipid-lowering therapy in patients with atherosclerotic CVD is also discussed.

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About the authors

Marina V. Leonova

Interregional Public Organization of the Association of Clinical Pharmacologists (Moscow branch)

Author for correspondence.
Email: anti23@mail.ru
ORCID iD: 0000-0001-8228-1114
SPIN-code: 3281-7884

Dr. Sci. (Med.), Professor, Corresponding Member of the Russian Academy of Natural Sciences, Member of the Interregional Public Organization of the Association of Clinical Pharmacologists

Russian Federation, Moscow

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