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Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial

AIMS: Co-primary objectives were to evaluate dalcetrapib (JTT-705/RO4607381), which targets cholesteryl ester transfer protein (CETP), effects on high-density lipoprotein cholesterol (HDL-C) in participants with coronary heart disease or risk equivalents and to evaluate potential changes in mesenter...

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Autores principales: Stein, Evan A., Roth, Eli M., Rhyne, James M., Burgess, Tracy, Kallend, David, Robinson, Jennifer G.
Formato: Texto
Lenguaje:English
Publicado: Oxford University Press 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2821630/
https://www.ncbi.nlm.nih.gov/pubmed/20097702
http://dx.doi.org/10.1093/eurheartj/ehp601
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author Stein, Evan A.
Roth, Eli M.
Rhyne, James M.
Burgess, Tracy
Kallend, David
Robinson, Jennifer G.
author_facet Stein, Evan A.
Roth, Eli M.
Rhyne, James M.
Burgess, Tracy
Kallend, David
Robinson, Jennifer G.
author_sort Stein, Evan A.
collection PubMed
description AIMS: Co-primary objectives were to evaluate dalcetrapib (JTT-705/RO4607381), which targets cholesteryl ester transfer protein (CETP), effects on high-density lipoprotein cholesterol (HDL-C) in participants with coronary heart disease or risk equivalents and to evaluate potential changes in mesenteric lymph nodes. METHODS AND RESULTS: Double-blind trial with participants randomized (2:1) to dalcetrapib 900 mg/day (higher than 600 mg phase III dose) or placebo, both with atorvastatin, for 24 weeks (n = 135; one without post-baseline efficacy data was excluded from intent-to-treat population); a subset continued for 24-week extension (n = 77). Lipid changes and safety parameters were assessed. Mesenteric lymph nodes were evaluated by magnetic resonance imaging. Dalcetrapib increased HDL-C (33.4%, Week 24; 33.8%, Week 48), decreased CETP activity (–53.5%, Week 24; –56.5%, Week 48), and increased apolipoprotein A-I (11.4%, Week 24; 16.4%, Week 48). Dalcetrapib showed no clinically relevant differences vs. placebo in adverse events, laboratory parameters including aldosterone, electrocardiograms, and vital signs including blood pressure (BP). Dalcetrapib had no measurable, clinically relevant effect on lymph node size. CONCLUSION: Dalcetrapib 900 mg administered for up to 48 weeks showed no clinically relevant changes in lymph nodes, BP, or other safety parameters. Dalcetrapib effectively increased HDL-C over 48 weeks of treatment.
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spelling pubmed-28216302010-02-16 Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial Stein, Evan A. Roth, Eli M. Rhyne, James M. Burgess, Tracy Kallend, David Robinson, Jennifer G. Eur Heart J Clinical Research AIMS: Co-primary objectives were to evaluate dalcetrapib (JTT-705/RO4607381), which targets cholesteryl ester transfer protein (CETP), effects on high-density lipoprotein cholesterol (HDL-C) in participants with coronary heart disease or risk equivalents and to evaluate potential changes in mesenteric lymph nodes. METHODS AND RESULTS: Double-blind trial with participants randomized (2:1) to dalcetrapib 900 mg/day (higher than 600 mg phase III dose) or placebo, both with atorvastatin, for 24 weeks (n = 135; one without post-baseline efficacy data was excluded from intent-to-treat population); a subset continued for 24-week extension (n = 77). Lipid changes and safety parameters were assessed. Mesenteric lymph nodes were evaluated by magnetic resonance imaging. Dalcetrapib increased HDL-C (33.4%, Week 24; 33.8%, Week 48), decreased CETP activity (–53.5%, Week 24; –56.5%, Week 48), and increased apolipoprotein A-I (11.4%, Week 24; 16.4%, Week 48). Dalcetrapib showed no clinically relevant differences vs. placebo in adverse events, laboratory parameters including aldosterone, electrocardiograms, and vital signs including blood pressure (BP). Dalcetrapib had no measurable, clinically relevant effect on lymph node size. CONCLUSION: Dalcetrapib 900 mg administered for up to 48 weeks showed no clinically relevant changes in lymph nodes, BP, or other safety parameters. Dalcetrapib effectively increased HDL-C over 48 weeks of treatment. Oxford University Press 2010-02 2010-01-22 /pmc/articles/PMC2821630/ /pubmed/20097702 http://dx.doi.org/10.1093/eurheartj/ehp601 Text en Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2010. For permissions please email: journals.permissions@oxfordjournals.org. http://creativecommons.org/licenses/by-nc/2.0/uk/ The online version of this article has been published under an open access model. Users are entitled to use, reproduce, disseminate, or display the open access version of this article for non-commercial purposes provided that the original authorship is properly and fully attributed; the Journal, Learned Society and Oxford University Press are attributed as the original place of publication with correct citation details given; if an article is subsequently reproduced or disseminated not in its entirety but only in part or as a derivative work this must be clearly indicated. For commercial re-use, please contact journals.permissions@oxfordjournals.org.
spellingShingle Clinical Research
Stein, Evan A.
Roth, Eli M.
Rhyne, James M.
Burgess, Tracy
Kallend, David
Robinson, Jennifer G.
Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial
title Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial
title_full Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial
title_fullStr Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial
title_full_unstemmed Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial
title_short Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial
title_sort safety and tolerability of dalcetrapib (ro4607381/jtt-705): results from a 48-week trial
topic Clinical Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2821630/
https://www.ncbi.nlm.nih.gov/pubmed/20097702
http://dx.doi.org/10.1093/eurheartj/ehp601
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