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Cordaptive Causes Less Flushing, More Side effects Than Niaspan

http://www.reuters.com/article/marketsNews/idUKN3139291120080331

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By Ransdell Pierson

NEW YORK, March 31 (Reuters) - Merck & Co's (MRK) Cordaptive pill to raise "good" HDL cholesterol caused less facial flushing in a study than Abbott Laboratories Inc's (ABT) Niaspan treatment, but with certain increased side effects, researchers said on Monday. The results were described at the annual meeting of the American College of Cardiology in Chicago.

Merck's experimental drug contains an extended-release form of the vitamin niacin to raise levels of HDL. It also contains a chemical called laropiprant to stop flushing, a dilation of blood vessels that causes redness and an unpleasant burning sensation on the neck and face.

Flushing is a common side effect of niacin-based drugs, and the biggest reason many patients stop taking current products, including Niaspan. Results from the late-stage study of Cordaptive suggest the problem was largely averted and could boost interest in HDL-raising therapy, Merck said.

Although overall other side effects were similar among patients taking Cordaptive and Niaspan, those taking the Merck drug had elevations in liver enzymes -- a potential sign of toxicity -- and diabetics had to adjust their medicines due to an impact on their blood sugar.

Dr. Michael Koren, a Jacksonville, Florida, cardiologist who led the study, said none of the side effects was worrisome, although patients were taken out of the study if they developed elevated liver enzymes.

Elevated enzymes are a common side effect of cholesterol medicines and are typically managed by lowering the dosage of such drugs, Koren said.

"I think (Cordaptive) will be deemed as safe as niacin, but we will need to monitor it as we do statins," if it is approved, Koren said.

The phase 3 study involved 1,455 patients, aged 18 to 80, with either high levels of artery-clogging LDL cholesterol or blood fats called triglycerides, or low levels of heart-protective HDL.

One group of patients received Cordaptive, beginning with 1-gram doses of the niacin component for the first month, and taking the full recommended 2-gram dose of niacin for the remaining 12 weeks of the study.

Another group took Niaspan, starting with 500 milligram doses of the extended release form of niacin and graduating to the recommended 2-gram dose by week twelve. They continued to take that dose for the remaining four weeks.
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