Merck reports encouraging results from Phase IIb hypercholesterolemia trial
MRK | Quote | Chart | News | PowerRating -- Merck has reported that in a Phase IIb study in 589 patients with primary hypercholesterolemia or mixed hyperlipidemia treated with anacetrapib as monotherapy or co-administered with atorvastatin, there were persistent lipid effects in the higher dose arms in both the monotherapy and co-administration treatment groups eight weeks after stopping active therapy with anacetrapib.
Anacetrapib is an investigational oral compound currently in Phase III trials that works by inhibiting the activity of cholesterol ester transfer protein (CETP) in the blood. CETP inhibition with anacetrapib decreases low-density lipoprotein-cholesterol (LDL-C) levels and increases high-density lipoprotein-cholesterol (HDL-C) levels. The effect of CETP inhibition on cardiovascular risk has yet to be established.
The results represent the second part of a randomized, double-blind, placebo-controlled, parallel-group dose-ranging study. In part one of the study, 539 patients aged 18-75 years and with moderate elevations in LDL-C were randomized to either anacetrapib (at 10, 40, 150, or 300mg doses) plus placebo, or anacetrapib (at 10, 40, 150, or 300mg doses) plus atorvastatin 20mg for an eight-week period.
In part two of the study, treatment with anacetrapib was stopped and patients continued to receive either placebo or atorvastatin 20mg for an additional eight weeks. The effect of withdrawal of the drug on lipid efficacy (LDL-C, HDL-C, total cholesterol, non-HDL-C, apo B, apo A-1), CETP levels and safety were assessed. Safety was assessed through physical examination, vital signs, laboratory evaluations, electrocardiograms, blood pressure measurements and adverse event assessments.
In the reversal phase of the study, eight weeks after cessation of therapy persistent lipid effects remained in the higher dose arms (150mg and 300mg) for both the anacetrapib monotherapy and co-administration treatment groups. These effects may be due to persistent drug levels which are likely related to the high lipid solubility of the drug. Also in the study, there were no patterns of clinically important blood pressure elevations or adverse experiences in the treatment groups, said Merck.
Yale Mitchel, vice president of cardiovascular disease clinical research at Merck Research Laboratories, said: "The study findings add to the data from the initial Phase IIb efficacy and safety results published in the American Heart Journal in February 2009. A Phase III trial, titled Define, is ongoing to further evaluate the safety and efficacy of anacetrapib in patients with coronary heart disease and will provide important information on this compound."
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