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


ABSTRACT: 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?

SUBMITTER: Ballantyne CM 

PROVIDER: S-EPMC7153222 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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

Ballantyne Christie M CM   Laufs Ulrich U   Ray Kausik K KK   Leiter Lawrence A LA   Bays Harold E HE   Goldberg Anne C AC   Stroes Erik Sg ES   MacDougall Diane D   Zhao Xin X   Catapano Alberico L AL  

European journal of preventive cardiology 20190729 6


<h4>Aims</h4>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.<h4>Methods</h4>This phase 3, double-blind clinical trial enrolled adult patients at high risk of cardiovascular disease due to atherosclerotic cardiovascular disease, heterozygous fami  ...[more]

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