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ARTICLE | Clinical News

Dalcetrapib data published

November 6, 2012 2:29 AM UTC

Detailed results from the Phase III dal-OUTCOMES trial to treat coronary heart disease (CHD) showed dalcetrapib from Roche (SIX:ROG; OTCQX:RHHBY) missed the primary endpoint which consisted of a composite of time to first occurrence of CHD death, non-fatal acute myocardial infarction (MI), hospitalization for unstable angina, resuscitated cardiac arrest or stroke. The endpoint occurred in 8.3% of patient receiving dalcetrapib plus standard of care vs. 8% for placebo plus standard of care (p=0.52). Roche discontinued development of dalcetrapib in May after the compound showed a "lack of clinically meaningful efficacy" in a second interim analysis of the Phase III dal-OUTCOMES trial.

The small molecule inhibitor of cholesteryl ester transfer protein (CETP) did increase HDL-C by 31-40% from baseline to a median follow-up of 31 months vs. 4-11% for placebo. Dalcetrapib had a "minimal effect" on LDL-C. Data were published in the New England Journal of Medicine and were presented at the American Heart Association meeting in Los Angeles. ...