Phase 3 study of anacetrapib for treatment of coronary heart disease (CHD)
Merck announced results from its Phase 3 study of anacetrapib in patients with coronary heart disease (CHD) or CHD risk equivalents. This study, known as the DEFINE trial, was an 18-month study in more than 1,600 patients with or at high risk for CHD who were already receiving statins and were at guideline-established LDL-C goal. The study was designed to assess the lipid-modifying efficacy, safety and tolerability of anacetrapib 100mg daily added to ongoing statin therapy with or without other lipid-modifying agents. There were no significant differences between the anacetrapib and placebo-treated patients in mean change from baseline in systolic (0.2 mmHg, p=0.83) or diastolic blood pressure (0.0 mmHg, p=0.96), nor in the percentage of patients reported to have increased blood pressure. The number of patients with clinically important changes in serum electrolytes (sodium, potassium, chloride and bicarbonate) was not significantly different between those who received anacetrapib and those given placebo during the 76-week treatment period (p value range 0.25 to 0.99), nor was there any difference in mean change from baseline in aldosterone levels between the two groups over 76 weeks (20.4 pg/mL vs. 18.4 pg/mL, respectively). In addition, there were no cases of rhabdomyolysis (severe muscle injury infrequently associated with lipid-lowering drugs) in either the anacetrapib or the placebo treatment groups.
Anacetrapib is Merck's investigational cholesteryl ester transfer protein (CETP) inhibitor being developed for the treatment of hyperlipidemia.
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