http://www.theheart.org/article/1395141.do
Roche has stopped the phase 3 dal-OUTCOMES trial of the cholesteryl ester transfer protein (CETP) inhibitor dalcetrapib after interim analysis of the study showed the HDL-cholesterol-boosting drug was not significantly reducing cardiovascular adverse events [1].
As reported by heartwire, the earlier dal-PLAQUE
study showed that dalcetrapib reduced inflammation in the carotid
artery and that there was an inverse relationship between
HDL-cholesterol levels and markers of arterial inflammation in patients
treated with the drug. Dal-OUTCOMES was a major morbidity and mortality
study currently planned for about 16 000 stable coronary heart disease
patients with recent acute coronary syndrome (ACS). Patients in the
study were randomized to either 600 mg daily of dalcetrapib and standard
medical therapy or placebo and standard medical therapy.
The primary outcome was time to first
occurrence of any component of the composite cardiovascular events.
Secondary outcomes included all-cause mortality, change from baseline in
blood lipids and lipoprotein levels, adverse events, lab parameters,
vital signs, and ECG. The company says there were no adverse safety
signals in the interim analysis.
Researchers hoped dalcetrapib was a CETP inhibitor that could succeed where torcetrapib
failed. Torcetrapib was abandoned when studies showed it appeared to
increase the risk of cardiovascular events despite substantially
increasing HDL-cholesterol levels.
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