TUESDAY, Sept. 13 (HealthDay News) -- Dalcetrapib is safe and reduces change in total vessel area and most-diseased-segment target-to-background ratio (TBR) as revealed by magnetic resonance imaging (MRI) and positron emission tomography-computed tomography (PET/CT), according to a study published online Sept. 12 in The Lancet.
Zahi A. Fayad, Ph.D., from the Mount Sinai School of Medicine in New York City, and colleagues examined whether dalcetrapib causes an increase in atherosclerotic plaque progression or vascular inflammation. A total of 130 patients with coronary heart disease, aged 18 to 75 years, were administered either dalcetrapib 600 mg/day (64 patients) or placebo (66 patients) for 24 months. MRI-assessed indices, including total vessel area, wall area, wall thickness, and normalised wall index after 24 months, and 18F-fluorodeoxyglucose PET/CT assessment of arterial inflammation within an index vessel after six months, with no-harm boundaries, were the co-primary end points.
The investigators found that confidence intervals were below the no-harm boundary or that adverse change was lower in the dalcetrapib group for co-primary MRI and PET/CT end points as compared to placebo group. After 24 months, the MRI-derived change in total vessel area was found to have significantly decreased, with an absolute change of −4.01 mm² relative to baseline in the dalcetrapib group. No difference was observed in PET/CT measure of index vessel most-diseased-segment TBR between the groups, but carotid artery analysis revealed a 7 percent decrease in most-diseased-segment TBR with dalcetrapib versus the placebo group. Adverse event frequency was similar between the two groups, and dalcetrapib did not increase office blood pressure.
"Dalcetrapib showed no evidence of a pathological effect related to the arterial wall over 24 months," the authors write.
Several of the study authors disclosed financial ties with the pharmaceutical industry, including F. Hoffmann-La Roche Ltd., which funded the study.
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