Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy

Aims The aim of this study was to evaluate the low-density lipoprotein cholesterol lowering efficacy and safety of a bempedoic acid 180 mg and ezetimibe 10 mg fixed-dose combination in patients with hypercholesterolemia and a high risk of cardiovascular disease receiving maximally tolerated statin t...

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Bibliographic Details
Published in:European journal of preventive cardiology 2020-04, Vol.27 (6), p.593-603
Main Authors: Ballantyne, Christie M, Laufs, Ulrich, Ray, Kausik K, Leiter, Lawrence A, Bays, Harold E, Goldberg, Anne C, Stroes, Erik SG, MacDougall, Diane, Zhao, Xin, Catapano, Alberico L
Format: Article
Language:English
Subjects:
Aged
Anticholesteremic Agents - administration & dosage
Anticholesteremic Agents - adverse effects
Biomarkers - blood
Cardiovascular Diseases - blood
Cardiovascular Diseases - diagnosis
Cardiovascular Diseases - prevention & control
Cholesterol, LDL - blood
Dicarboxylic Acids - administration & dosage
Dicarboxylic Acids - adverse effects
Double-Blind Method
Down-Regulation
Drug Combinations
Drug Treatment
Ezetimibe - administration & dosage
Ezetimibe - adverse effects
Fatty Acids - administration & dosage
Fatty Acids - adverse effects
Female
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
Hypercholesterolemia - blood
Hypercholesterolemia - diagnosis
Hypercholesterolemia - drug therapy
Male
Middle Aged
Time Factors
Treatment Outcome
United States
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Summary:Aims The aim of this study was to evaluate the low-density lipoprotein cholesterol lowering efficacy and safety of a bempedoic acid 180 mg and ezetimibe 10 mg fixed-dose combination in patients with hypercholesterolemia and a high risk of cardiovascular disease receiving maximally tolerated statin therapy. Methods This phase 3, double-blind clinical trial enrolled adult patients at high risk of cardiovascular disease due to atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, or multiple cardiovascular disease risk factors. Patients were randomly assigned (2:2:2:1) to treatment with the fixed-dose combination, bempedoic acid 180 mg, ezetimibe 10 mg or placebo added to stable background statin therapy for 12 weeks. The primary efficacy endpoint was the percentage change from baseline to week 12 in low-density lipoprotein cholesterol. Results Among the 301 patients included in the primary analysis, the mean baseline low-density lipoprotein cholesterol level was 3.87 mmol/L (149.8 mg/dL). At week 12, the fixed-dose combination lowered low-density lipoprotein cholesterol (–36.2%) significantly more than placebo (1.8% (placebo-corrected difference –38.0%); P 
ISSN:2047-4873
2047-4881
DOI:10.1177/2047487319864671