Safety and efficacy of dalcetrapib on atherosclerotic disease using novel non-invasive multimodality imaging (dal-PLAQUE): a randomised clinical trial
| Journal Title: | The Lancet (British edition) 2011, Vol.378 (9802), p.1547-1559 |
| Main Author: | Fayad, Zahi A, Prof |
| Other Authors: | Mani, Venkatesh, PhD , Woodward, Mark, Prof , Kallend, David, MB BS , Abt, Markus, PhD , Burgess, Tracy, MSc , Fuster, Valentin, Prof , Ballantyne, Christie M, Prof , Stein, Evan A, Prof , Tardif, Jean-Claude, Prof , Rudd, James H F, MD , Farkouh, Michael E, MD , Tawakol, Ahmed, MD |
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 Electronic Article
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English |
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| Quelle: | Alma/SFX Local Collection |
| Publisher: | Kidlington: Elsevier Ltd |
| ID: | ISSN: 0140-6736 |
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| recordid: | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4151875 |
| title: | Safety and efficacy of dalcetrapib on atherosclerotic disease using novel non-invasive multimodality imaging (dal-PLAQUE): a randomised clinical trial |
| format: | Article |
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| ispartof: | The Lancet (British edition), 2011, Vol.378 (9802), p.1547-1559 |
| description: | Summary Background Dalcetrapib modulates cholesteryl ester transfer protein (CETP) activity to raise high-density lipoprotein cholesterol (HDL-C). After the failure of torcetrapib it was unknown if HDL produced by interaction with CETP had pro-atherogenic or pro-inflammatory properties. dal-PLAQUE is the first multicentre study using novel non-invasive multimodality imaging to assess structural and inflammatory indices of atherosclerosis as primary endpoints. Methods In this phase 2b, double-blind, multicentre trial, patients (aged 18–75 years) with, or with high risk of, coronary heart disease were randomly assigned (1:1) to dalcetrapib 600 mg/day or placebo for 24 months. Randomisation was done with a computer-generated randomisation code and was stratified by centre. Patients and investigators were masked to treatment. Coprimary endpoints were MRI-assessed indices (total vessel area, wall area, wall thickness, and normalised wall index [average carotid]) after 24 months and18 F-fluorodeoxyglucose (18 F-FDG) PET/CT assessment of arterial inflammation within an index vessel (right carotid, left carotid, or ascending thoracic aorta) after 6 months, with no-harm boundaries established before unblinding of the trial. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov , NCT00655473. Findings 189 patients were screened and 130 randomly assigned to placebo (66 patients) or dalcetrapib (64 patients). For the coprimary MRI and PET/CT endpoints, CIs were below the no-harm boundary or the adverse change was numerically lower in the dalcetrapib group than in the placebo group. MRI-derived change in total vessel area was reduced in patients given dalcetrapib compared with those given placebo after 24 months; absolute change from baseline relative to placebo was −4·01 mm2 (90% CI −7·23 to −0·80; nominal p=0·04). The PET/CT measure of index vessel most-diseased-segment target-to-background ratio (TBR) was not different between groups, but carotid artery analysis showed a 7% reduction in most-diseased-segment TBR in the dalcetrapib group compared with the placebo group (–7·3 [90% CI −13·5 to −0·8]; nominal p=0·07). Dalcetrapib did not increase office blood pressure and the frequency of adverse events was similar between groups. Interpretation Dalcetrapib showed no evidence of a pathological effect related to the arterial wall over 24 months. Moreover, this trial suggests possible beneficial vascular effects of dalcetrapib, including the r |
| language: | eng |
| source: | Alma/SFX Local Collection |
| identifier: | ISSN: 0140-6736 |
| fulltext: | fulltext |
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