Researchers today presented results from the Phase III DEFINE (Determining the EFficacy and Tolerability of CETP INhibition with AnacEtrapib) study with Merck's investigational CETP inhibitor, anacetrapib. In the trial of 1,623 patients with coronary heart disease (CHD) or CHD risk equivalents, anacetrapib showed no significant differences from placebo in the primary safety measures studied. There were no significant differences in mean changes in blood pressure between the anacetrapib and placebo treatment groups, nor were there any significant differences in serum electrolytes or aldosterone levels. During the 76-week treatment phase, the pre-specified adjudicated cardiovascular endpoint (defined as cardiovascular death, myocardial infarction, unstable angina or stroke) occurred in 16 anacetrapib-treated patients (2.0 percent) compared with 21 placebo-treated patients (2.6 percent) (p=0.40). At 24 weeks, anacetrapib decreased LDL-C by 40 percent (from 81 to 45 mg/dl vs. 82 to 77 mg/dl for placebo, p An early member of the CETP inhibitor class, torcetrapib, was found to cause an excess of deaths and cardiovascular events. In the DEFINE study, all cardiovascular serious adverse events and deaths from any cause were adjudicated by a blinded, external, independent adjudication committee. Reports of revascularization and heart failure were collected and adjudicated, but were not part of the pre-specified cardiovascular composite endpoint. In DEFINE, pre-specified adjudicated cardiovascular events occurred in 16 patients given anacetrapib (2.0 percent) compared with 21 patients who received placebo (2.6 percent) (p=0.40), coronary revascularization was carried out in significantly fewer people given anacetrapib compared with those taking placebo (8 vs. 28, respectively, p
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