NEW YORK, Nov 5 (Reuters) - Patients were able to safely and comfortably use Merck & Co's (MRK.N: Quote, Profile, Research) experimental Cordaptive drug to raise "good" HDL cholesterol alongside Merck's older Zocor cholesterol medicine, with impressive cholesterol control, researchers said on Monday.
Results of the Phase III trial, which involved about 1,400 patients and lasted 12 weeks, were presented at the annual scientific sessions of the American Heart Association in Orlando, Florida.
Cordaptive is itself a combination of an extended release form of niacin -- a nutrient that raises heart-protective HDL -- and an experimental drug called laropiprant that reduces the uncomfortable facial flushing which is a side effect of niacin.
Industry analysts have said Cordaptive, now awaiting U.S. marketing approval, could be a big seller because sales of existing niacin-based drugs -- including Abbott Laboratories Inc's (ABT.N: Quote, Profile, Research) Niaspan -- have been limited due to their strong tendency to cause flushing.
Merck aims to seek approval next year for a separate product called MK-524B. It would combine Cordaptive in the same tablet with simvastatin, the active ingredient of Zocor which works by cutting the body's production of LDL.
In the trial described on Monday, levels of LDL fell 48 percent among patients receiving simvastatin as well as Cordaptive containing the full recommended 2 gram dose of niacin. That effectiveness against LDL, the primary goal of the trial, was deemed highly statistically significant.
The Cordaptive/simvastatin combination raised HDL cholesterol by 28 percent, while cutting levels of triglycerides -- a potentially harmful type of fat in the bloodstream --by 33 percent. Those results were also highly statistically significant.
Patients taking Cordaptive by itself in the trial experienced favorable, but less-impressive results: a 17 percent decrease in LDL, a 23 percent boost in HDL and a 22 percent drop in triglycerides.
About 4.8 percent of patients taking the Cordaptive/simvastatin combination dropped out of the trial due to flushing, compared with 8.7 percent of those taking Cordaptive alone and 0.3 percent taking simvastatin alone.
The discontinuation rate due to flushing was higher by a "slightly statistically significant" degree among those taking Cordaptive by itself than those taking it with simvastatin, Merck said. But the company did not speculate on reasons for the somewhat counter-intuitive trend.
Merck said levels of blood sugar rose somewhat among patients taking Cordaptive, noting that niacin has a tendency to increase blood glucose.
But overall side effects were similar among those taking simvastatin alone, and those taking Cordaptive either by itself or in combination with simvastatin, said John Paolini, a senior Merck research official.
"Addition of simvastatin does not change the safety profile," Paolini said.
"The results seen in this study suggest that Cordaptive with simvastatin together may offer a new strategy to treat patients" with high levels of LDL and triglycerides and/or low levels of HDL, said Dr. Christie Ballantyne, a Baylor College cardiologist who helped conduct the study.
Current cholesterol drugs like Zocor and Pfizer Inc's (PFE.N: Quote, Profile, Research) Lipitor, both members of the statin family of treatments, focus on reducing LDL.
Interest in HDL-raising drugs is intensifying because of data showing that a high percentage of people experiencing heart attacks have relatively normal levels of LDL, but low levels of protective HDL.
HDL works like a garbage truck, removing excess levels of artery-clogging LDL from the bloodstream. (Additional reporting by Kim Dixon in Orlando; Editing by Tim Dobbyn)
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