Merck Reports Cordaptive Phase III Data

Merck announced that in Phase III trials, Cordaptive, an investigational compound to treat dyslipidemia, reduced low-density lipoprotein-cholesterol levels, increased high-density lipoprotein cholesterol levels and reduced triglyceride levels when compared with placebo.

The study was a double-blind, randomized trial that evaluated the lipid efficacy and flushing profile of Cordaptive as either a monotherapy or when combined with a statin in 1,613 patients.

Approximately 65 percent of patients in the study were already on statin therapy. Each was at either 1gram of Cordaptive per day, 1 gram of extended-release niacin alone per day or placebo.

After four weeks, patients in the group being treated with Cordaptive and the group being treated with extended-release niacin doubled their respective doses to 2 grams per day for an additional 20 weeks.

In the study, patients who advanced to 2 grams of Cordaptive reduced their low-density lipoprotein-cholesterol levels from baseline by an average of 19 percent (versus a reduction of 0.5 percent with placebo), raised their increased high-density lipoprotein cholesterol levels by an average of 19 percent (versus a reduction of 1.2 percent with placebo), and reduced their triglyceride levels by an average of 22 percent (versus an increase of 3.6 percent with placebo).