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news.Merck & Co. has reported that Anacetrapib, its investigational selective cholesteryl ester transfer protein inhibitor, has significantly reduced "bad" cholestorol while raising levels of "good" cholestorol in a Phase IIb trial.
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The primary endpoint of the eight-week study was LDL-C reduction, with secondary endpoints of HDL-C increases and effects on other lipoproteins and apolipoproteins and blood pressure evaluated across ten treatment groups. Merck said that the drug reduced LDL-cholesterol and apolipoprotein B and increased HDL-cholesterol and apolipoprotein A-1 both as monotherapy and in combination with Pfizer’s Lipitor (atorvastatin) 20mg compared to placebo in patients with dyslipidemia.
In the study, anacetrapib monotherapy at doses of 10mg, 40mg, 150mg and 300mg reduced LDL-C levels by 16%, 27%, 40%, and 39%, and increased HDL-C levels by 44%, 86%, 139% and 133% compared to placebo (2% and 4%, respectively) in a dose dependent manner.
Anacetrapib co-administered with atorvastatin, across all doses studied, produced significant incremental reductions in LDL-C and increases in HDL-C compared to atorvastatin alone. The comparative lipid results in the study were statistically significant (p<0.001 vs. placebo for all doses). Daniel Bloomfield, clinical research at Merck Research Laboratories, said: "The favorable lipid effects seen in this study with multiple doses of anacetrapib were significant, and confirm the continued evaluation of the clinical benefits of CETP inhibitors in the treatment of dyslipidemia." In addition to these Phase IIb study results, Merck continues to carefully evaluate all of its data and other available information as its plans for anacetrapib are evaluated.