Journal article
Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial
European heart journal, Vol.31(4), pp.480-488
02/2010
DOI: 10.1093/eurheartj/ehp601
PMCID: PMC2821630
PMID: 20097702
Abstract
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.
Details
- Title: Subtitle
- Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial
- Creators
- Evan A. Stein - Louisville Metabolic and Atherosclerosis Research CenterEli M. Roth - Sterling Research GroupJames M. Rhyne - Louisville Metabolic and Atherosclerosis Research CenterTracy Burgess - Hoffmann-La Roche Inc. Nutley, NJ, USADavid Kallend - RocheJennifer G. Robinson - University of Iowa
- Resource Type
- Journal article
- Publication Details
- European heart journal, Vol.31(4), pp.480-488
- Publisher
- Oxford University Press
- DOI
- 10.1093/eurheartj/ehp601
- PMID
- 20097702
- PMCID
- PMC2821630
- ISSN
- 0195-668X
- eISSN
- 1522-9645
- Language
- English
- Date published
- 02/2010
- Academic Unit
- Epidemiology; Fraternal Order of Eagles Diabetes Research Center
- Record Identifier
- 9984364421902771
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