Abstract 1499: Effects of Co-Administered Ezetimibe/Simvastatin and Fenofibrate on Lipoprotein Subclasses and LDL Size Pattern in Patients with Mixed Hyperlipidemia
This analysis examined the effects of ezetimibe/simvastatin (EZE/SIMVA) and fenofibrate (FENO), alone and co-administered, on lipoprotein subclasses and LDL size patterns. Cholesterol associated with individual lipoprotein subclasses was quantified with the VAP-II method and LDL peak particle size and pattern (A, B, or I=intermediate) were determined with the S3GGE method. These results are from a 12-week, placebo-controlled trial, in which 611 patients (pts) with mixed hyperlipidemia were randomly assigned to 1 of 4 treatment groups in a 3:3:3:1 ratio: EZE/SIMVA 10/20 mg + FENO 160 mg; FENO 160 mg; EZE/SIMVA 10/20 mg; or placebo. Co-administered EZE/SIMVA and FENO reduced LDL-C (−45.8%), TG (−50.0%), non-HDL-C (−50.5%), and raised HDL-C (+18.7%) levels in this study. EZE/SIMVA+FENO and EZE/SIMVA had substantial effects on all 4 LDL subclasses, while FENO primarily affected LDL-2 and LDL-4 subclasses. IDL-C was reduced to a similar extent with EZE/SIMVA+FENO and EZE/SIMVA alone, but both were greater than the change observed with FENO. At baseline, approximately 60% of pts exhibited the small, dense LDL pattern B profile. At endpoint, ≥60% of pts in the EZE/SIMVA+FENO and FENO alone groups shifted to a larger, more buoyant LDL pattern; whereas, 14% of placebo pts and 23% of EZE/SIMVA pts shifted to a larger, more buoyant LDL pattern. Thus, in addition to improving the major lipids and lipoproteins, EZE/SIMVA+FENO produced favorable effects on atherogenic lipoprotein subclasses and LDL subclass pattern in pts with mixed hyperlipidemia.