November 18, 2010 – In the trial of 1,623 patients with coronary heart disease (CHD) or CHD risk equivalents, an investigational CETP inhibitor showed no significant differences from placebo in the primary safety measures studied. Researchers this week presented results from the phase III DEFINE study with Merck's CETP inhibitor, anacetrapib. The positive results were presented at the American Heart Association (AHA) meeting in Chicago.
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 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, pNew England Journal of Medicine.
The DEFINE trial was an 18-month study of patients with or at high-risk for CHD who were already receiving statins and were at guideline-established LDL-C goal. It was designed to assess the lipid-modifying efficacy, safety and tolerability of anacetrapib 100 mg daily added to ongoing statin therapy with or without other lipid-modifying agents.
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