Roche Stops Dalcetrapib Trial for Lack of Benefit

Reed Miller

May 07, 2012

May 7, 2012 (Basel, Switzerland) — 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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