PMID- 31357887
OWN - NLM
STAT- Publisher
LR  - 20190823
IS  - 2047-4881 (Electronic)
IS  - 2047-4873 (Linking)
DP  - 2019 Jul 29
TI  - Bempedoic acid plus ezetimibe fixed-dose combination in patients with
      hypercholesterolemia and high CVD risk treated with maximally tolerated statin
      therapy.
PG  - 2047487319864671
LID - 10.1177/2047487319864671 [doi]
AB  - 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 < 0.001), ezetimibe alone (-23.2%; P <
      0.001) or bempedoic acid alone (-17.2%; P < 0.001). The fixed-dose combination
      lowered low-density lipoprotein cholesterol levels similarly across subgroups,
      including patients receiving high-intensity, other-intensity or no statin
      therapy. Improvements with the fixed-dose combination were also observed in
      secondary efficacy endpoints, including high-sensitivity C-reactive protein. In
      this trial, fixed-dose combination treatment had a generally similar safety
      profile compared with bempedoic acid, ezetimibe or placebo. CONCLUSION: The
      bempedoic acid and ezetimibe fixed-dose combination significantly lowered
      low-density lipoprotein cholesterol versus placebo or other oral monotherapies
      and had a favourable safety profile when added to maximally tolerated statin
      therapy in patients with hypercholesterolemia and high cardiovascular disease
      risk. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03337308.
FAU - Ballantyne, Christie M
AU  - Ballantyne CM
AD  - 1 Department of Medicine, Baylor College of Medicine, USA.
FAU - Laufs, Ulrich
AU  - Laufs U
AD  - 2 Klinik und Poliklinik fur Kardiologie, Universitatsklinikum Leipzig, Germany.
FAU - Ray, Kausik K
AU  - Ray KK
AD  - 3 Imperial Centre for Cardiovascular Disease Prevention, Imperial College London,
      UK.
FAU - Leiter, Lawrence A
AU  - Leiter LA
AD  - 4 Division of Endocrinology and Metabolism, St Michael's Hospital, Canada.
FAU - Bays, Harold E
AU  - Bays HE
AD  - 5 Louisville Metabolic and Atherosclerosis Research Center, USA.
FAU - Goldberg, Anne C
AU  - Goldberg AC
AD  - 6 Washington University School of Medicine, USA.
FAU - Stroes, Erik Sg
AU  - Stroes ES
AD  - 7 Department of Vascular Medicine, Academic Medical Centre, The Netherlands.
FAU - MacDougall, Diane
AU  - MacDougall D
AD  - 8 Esperion Therapeutics, Inc., USA.
FAU - Zhao, Xin
AU  - Zhao X
AD  - 8 Esperion Therapeutics, Inc., USA.
FAU - Catapano, Alberico L
AU  - Catapano AL
AD  - 9 Department of Pharmacological and Biomolecular Sciences, University of Milan
      and Multimedica IRCCS, Italy.
LA  - eng
SI  - ClinicalTrials.gov/NCT03337308
PT  - Journal Article
DEP - 20190729
PL  - England
TA  - Eur J Prev Cardiol
JT  - European journal of preventive cardiology
JID - 101564430
SB  - IM
OTO - NOTNLM
OT  - Bempedoic acid
OT  - LDL-cholesterol
OT  - ezetimibe
OT  - hydroxymethylglutaryl-CoA reductase inhibitors
OT  - hypercholesterolemia
OT  - hyperlipidemias
OT  - hypolipidemic agents
OT  - lipid-regulating agents
EDAT- 2019/07/31 06:00
MHDA- 2019/07/31 06:00
CRDT- 2019/07/31 06:00
PHST- 2019/07/31 06:00 [pubmed]
PHST- 2019/07/31 06:00 [medline]
PHST- 2019/07/31 06:00 [entrez]
AID - 10.1177/2047487319864671 [doi]
PST - aheadofprint
SO  - Eur J Prev Cardiol. 2019 Jul 29:2047487319864671. doi: 10.1177/2047487319864671.