Experimental Merck Drug Reduces LDL Cholesterol, Flushing

Cordaptive, an investigational drug from Merck, reduced LDL cholesterol and triglyceride levels, and increased HDL cholesterol levels in a Phase III clinical trial, the company announced. Patients treated with Cordaptive also reported significantly less flushing compared with patients using extended-release niacin alone, Merck said.

The drug combines niacin with laropiprant, a novel inhibitor designed to reduce the flushing often associated with niacin treatment, the company said.

Although niacin is an effective lipid modifier, its use has been limited because of the flushing side effect, Merck added. Flushing is the dilation of blood vessels causing redness of the skin coupled with warming or burning on the face and neck.

In the trial, Cordaptive was administered in 1- and 2-gram doses alone, or added to ongoing statin therapy in patients with dyslipidemia.

According to the company, 69 percent of patients treated with 1 gram of Cordaptive reported either no flushing symptoms or mild flushing symptoms during the first week of treatment, compared with 44 percent of those who received extended-release niacin alone.

Almost half of the patients in the extended-release niacin group reported moderate or greater flushing symptoms during the first week, compared with 27 percent treated with Cordaptive, Merck said.

Six months into the study, the frequency of moderate or greater flushing was 0.7 days per week among those treated with 2 grams of extended-release niacin, versus 0.2 days per week for patients taking 2 grams of Cordaptive or a placebo.

In addition, more than twice as many patients on extended-release niacin discontinued treatment because of flushing than patients taking Cordaptive — 22 percent versus 10 percent, the company said.