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Alirocumab Treatment and Achievement of Non‐High‐Density Lipoprotein Cholesterol and Apolipoprotein B Goals in Patients With Hypercholesterolemia: Pooled Results From 10 Phase 3 ODYSSEY Trials

BACKGROUND: Non‐high‐density lipoprotein cholesterol (non‐HDL‐C) and apolipoprotein (apo) B are better predictors of atherosclerotic cardiovascular disease risk than low‐density lipoprotein cholesterol alone. US and European lipid management guidelines support non‐HDL‐C and apoB as targets for lipid...

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Autores principales: Bays, Harold E., Leiter, Lawrence A., Colhoun, Helen M., Thompson, Desmond, Bessac, Laurence, Pordy, Robert, Toth, Peter P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5586424/
https://www.ncbi.nlm.nih.gov/pubmed/28862926
http://dx.doi.org/10.1161/JAHA.117.005639
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author Bays, Harold E.
Leiter, Lawrence A.
Colhoun, Helen M.
Thompson, Desmond
Bessac, Laurence
Pordy, Robert
Toth, Peter P.
author_facet Bays, Harold E.
Leiter, Lawrence A.
Colhoun, Helen M.
Thompson, Desmond
Bessac, Laurence
Pordy, Robert
Toth, Peter P.
author_sort Bays, Harold E.
collection PubMed
description BACKGROUND: Non‐high‐density lipoprotein cholesterol (non‐HDL‐C) and apolipoprotein (apo) B are better predictors of atherosclerotic cardiovascular disease risk than low‐density lipoprotein cholesterol alone. US and European lipid management guidelines support non‐HDL‐C and apoB as targets for lipid‐lowering therapy. METHODS AND RESULTS: This analysis evaluated the efficacy of alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, on non‐HDL‐C and apoB. Data were derived from 4983 patients enrolled in 10 randomized, placebo‐ or ezetimibe‐controlled Phase 3 ODYSSEY trials. Primary end point for this pooled analysis was percent reduction in non‐HDL‐C and apoB at Week 24; secondary end points included the percentage of patients achieving guideline‐directed treatment goals (National Lipid Association guidelines: non‐HDL‐C <100 or <130 mg/dL for patients at very high and high cardiovascular risk, respectively; European Society of Cardiology/European Atherosclerosis Society guidelines: apoB <80 mg/dL for patients at very‐high cardiovascular risk). Data were grouped according to comparator, alirocumab starting dose, and concomitant statin use. Compared with controls, alirocumab produced significantly greater reductions in non‐HDL‐C and apoB at Week 24 (P<0.0001), an effect extending up to 78 weeks. More alirocumab‐treated patients achieved levels of non‐HDL‐C <100 mg/dL and apoB <80 mg/dL (P≤0.0001 versus control). By Week 24, >70% of alirocumab‐treated patients on background statin achieved non‐HDL‐C <100 or <130 mg/dL, and apoB <80 mg/dL. Safety was comparable across pooled groups and in line with previous reports. CONCLUSIONS: Alirocumab produced significant, sustained reductions in non‐HDL‐C and apoB, allowing more patients to achieve lipid goals compared with placebo or ezetimibe and irrespective of maximally tolerated statin use.
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spelling pubmed-55864242017-09-11 Alirocumab Treatment and Achievement of Non‐High‐Density Lipoprotein Cholesterol and Apolipoprotein B Goals in Patients With Hypercholesterolemia: Pooled Results From 10 Phase 3 ODYSSEY Trials Bays, Harold E. Leiter, Lawrence A. Colhoun, Helen M. Thompson, Desmond Bessac, Laurence Pordy, Robert Toth, Peter P. J Am Heart Assoc Original Research BACKGROUND: Non‐high‐density lipoprotein cholesterol (non‐HDL‐C) and apolipoprotein (apo) B are better predictors of atherosclerotic cardiovascular disease risk than low‐density lipoprotein cholesterol alone. US and European lipid management guidelines support non‐HDL‐C and apoB as targets for lipid‐lowering therapy. METHODS AND RESULTS: This analysis evaluated the efficacy of alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, on non‐HDL‐C and apoB. Data were derived from 4983 patients enrolled in 10 randomized, placebo‐ or ezetimibe‐controlled Phase 3 ODYSSEY trials. Primary end point for this pooled analysis was percent reduction in non‐HDL‐C and apoB at Week 24; secondary end points included the percentage of patients achieving guideline‐directed treatment goals (National Lipid Association guidelines: non‐HDL‐C <100 or <130 mg/dL for patients at very high and high cardiovascular risk, respectively; European Society of Cardiology/European Atherosclerosis Society guidelines: apoB <80 mg/dL for patients at very‐high cardiovascular risk). Data were grouped according to comparator, alirocumab starting dose, and concomitant statin use. Compared with controls, alirocumab produced significantly greater reductions in non‐HDL‐C and apoB at Week 24 (P<0.0001), an effect extending up to 78 weeks. More alirocumab‐treated patients achieved levels of non‐HDL‐C <100 mg/dL and apoB <80 mg/dL (P≤0.0001 versus control). By Week 24, >70% of alirocumab‐treated patients on background statin achieved non‐HDL‐C <100 or <130 mg/dL, and apoB <80 mg/dL. Safety was comparable across pooled groups and in line with previous reports. CONCLUSIONS: Alirocumab produced significant, sustained reductions in non‐HDL‐C and apoB, allowing more patients to achieve lipid goals compared with placebo or ezetimibe and irrespective of maximally tolerated statin use. John Wiley and Sons Inc. 2017-08-08 /pmc/articles/PMC5586424/ /pubmed/28862926 http://dx.doi.org/10.1161/JAHA.117.005639 Text en © 2017 The Authors, Regeneron Pharmaceuticals, and Sanofi. Published on behalf of the American Heart Association, Inc., by Wiley. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Original Research
Bays, Harold E.
Leiter, Lawrence A.
Colhoun, Helen M.
Thompson, Desmond
Bessac, Laurence
Pordy, Robert
Toth, Peter P.
Alirocumab Treatment and Achievement of Non‐High‐Density Lipoprotein Cholesterol and Apolipoprotein B Goals in Patients With Hypercholesterolemia: Pooled Results From 10 Phase 3 ODYSSEY Trials
title Alirocumab Treatment and Achievement of Non‐High‐Density Lipoprotein Cholesterol and Apolipoprotein B Goals in Patients With Hypercholesterolemia: Pooled Results From 10 Phase 3 ODYSSEY Trials
title_full Alirocumab Treatment and Achievement of Non‐High‐Density Lipoprotein Cholesterol and Apolipoprotein B Goals in Patients With Hypercholesterolemia: Pooled Results From 10 Phase 3 ODYSSEY Trials
title_fullStr Alirocumab Treatment and Achievement of Non‐High‐Density Lipoprotein Cholesterol and Apolipoprotein B Goals in Patients With Hypercholesterolemia: Pooled Results From 10 Phase 3 ODYSSEY Trials
title_full_unstemmed Alirocumab Treatment and Achievement of Non‐High‐Density Lipoprotein Cholesterol and Apolipoprotein B Goals in Patients With Hypercholesterolemia: Pooled Results From 10 Phase 3 ODYSSEY Trials
title_short Alirocumab Treatment and Achievement of Non‐High‐Density Lipoprotein Cholesterol and Apolipoprotein B Goals in Patients With Hypercholesterolemia: Pooled Results From 10 Phase 3 ODYSSEY Trials
title_sort alirocumab treatment and achievement of non‐high‐density lipoprotein cholesterol and apolipoprotein b goals in patients with hypercholesterolemia: pooled results from 10 phase 3 odyssey trials
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5586424/
https://www.ncbi.nlm.nih.gov/pubmed/28862926
http://dx.doi.org/10.1161/JAHA.117.005639
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