Combined Therapy of Ezetimibe/Simvastatin plus Extended-Release Niacin Helps Hyperlipidemic Patients Reach Lipid Goals

NEW ORLEANS, LA—Data presented at ACC.11, the American College of Cardiology's 60th Annual Scientific Session, demonstrated that combination ezetimibe/simvastatin + extended-release niacin (E/S+N) is an effective therapeutic option for reaching lipid goals in patients with hyperlipidemia, specifically as regards target LDL-C, non-HDL-C, and apoB levels.

Study lead Sergio Fazio, MD, of Vanderbilt University, Nashville, Tennessee, and colleagues performed an analysis of a randomized, double-blind study that assessed the effect of ezetimibe/simvastatin + extended-release niacin vs. ezetimibe/simvastatin  and/or extended-release niacin monotherapy on the attainment of specified LDL-C, non-HDL-C and apoB levels in type IIA/IIB hyperlipidemic patients. The study also evaluated subgroups with high CHD risk (+/- atherosclerotic vascular diseases [AVD]), diabetes mellitus (DM), metabolic syndrome (MetS/nonDM), and nonDM/nonMetS. The study was funded by Merck & Co.

Patients were randomized to receive ezetimibe/simvastatin 10/20mg + extended-release niacin to 2g or ezetimibe/simvastatin 10/20mg for 64 weeks, or extended-release niacin to 2g for 24 weeks followed by then ezetimibe/simvastatin 10/20mg + extended-release niacin to 2g or ezetimibe/simvastatin 10/20mg for 40 weeks more.

A significantly greater number of hyperlipidemic patients on ezetimibe/simvastatin + extended-release niacin attained concomitant levels of LDL-C, non-HDL-C and apoB (Cluster 1: <100mg/dL, <130mg/dL and <90mg/dL for high CHD risk; Cluster 2: <70mg/dL, <100mg/dL, and <80mg/dL for very high CHD risk [See Figure]) compared with extended-release niacin and ezetimibe/simvastatin at 24 weeks and ezetimibe/simvastatin at 64 weeks. Attainment rates at 24 and 64 weeks in all subgroups were significantly greater with ezetimibe/simvastatin + extended-release niacin vs. extended-release niacin, and generally numerically to statistically greater with ezetimibe/simvastatin + extended-release niacin versus ezetimibe/simvastatin. Greater attainment of all three specified lipid levels was most consistent with single level attainment of non-HDL-C.