The double-blind, parallel, 12-week study with seven treatment arms in almost 1400 patients evaluated 1g of Cordaptive (1g extended-release niacin/20mg laropiprant) co-administered with simvastatin 10mg to 40mg in weeks one through four and 2g of Cordaptive (two 1g tablets each containing 1g extended-release niacin/20mg of laropiprant) co-administered with simvastatin 20mg to 40mg in weeks five through 12 (n=590). Tolerability and the safety profile of Cordaptive co-administered with simvastatin were also evaluated.
In the study, 2g (two 1g tablets) of Cordaptive co-administered with simvastatin (pooled across 20mg or 40mg doses) reduced LDL-cholesterol by 48%, increased HDL-cholesterol by 28%, and reduced triglyceride levels by 33% following 12 weeks of treatment. The primary study endpoint was LDL-cholesterol reduction and secondary endpoints included increased HDL- cholesterol, triglyceride reduction and effects on other lipoproteins.
Christie Ballantyne, associate chief and professor of medicine at Baylor College of Medicine, said: “The results in this study suggest that, if approved, Cordaptive used with a statin could offer another approach to treat patients with dyslipidemia.”