MERCK PRESENTS DATA ON NIACIN DRUG THAT REDUCES FLUSHING

Merck presented data at the American Heart Association's Scientific Sessions 2006 showing that coadministration of MK-0524, an investigational DP1-receptor antagonist, with extended-release niacin (ERN) significantly reduced flushing in patients with dyslipidemia compared with those patients who took ERN alone. Flushing, redness of the skin with warming or burning on the face and neck caused by the dilation of blood vessels near the skin, is a common niacin-induced side effect that is a significant factor leading to discontinuation of niacin therapy, according to Merck.

In the eight-week Phase II study, 412 patients with dyslipidemia were randomized to one of four groups: ERN 1 gram (given as Niaspan); ERN 1 gram plus MK-0524; ERN 1 g plus placebo; or double placebo. After starting treatment, patients reported flushing intensity in an electronic diary using the validated numerical and descriptive 11-point Global Flushing Severity Score.

All doses of MK-0524 plus ERN were effective in significantly reducing flushing intensity during both the initiation phase and maintenance phase when compared to patients taking ERN alone. During the first week of therapy with ERN alone, 61 percent of patients reported clinically significant moderate, severe or extreme flushing compared with 37 percent of patients treated with ERN administered with MK-0524. Thirteen percent of patients treated with double placebo experienced moderate or worse flushing. During the maintenance phase, the rate of moderate or severe ERN-induced flushing for patients treated with MK-0524 given with ERN was similar to patients treated with placebo.

Over the eight-week treatment period, lipids were very favorably affected: MK-0524 plus ERN increased HDL-cholesterol by 22.9 percent and reduced LDL-cholesterol and triglycerides by 13.2 percent and 26.5 percent, respectively. There was no difference in lipid response when MK-0524 with ERN was compared with treatment with ERN alone.