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(Circulation. 2006;114:II_112.)
© 2006 American Heart Association, Inc.

Integrative Lipoprotein Studies

Abstract 668: Lipoprotein Particle Size Effects of Colesevelam HCl in Combination with Ezetimibe and Simvastatin

Harold Bays¹; James Rhyne²; Stacey Abby³; Yu-Ling Lai³; Michael Jones³

¹ Louisville Metabolic and Atherosclerosis Rsch Cntr Inc., Louisville, KY
² The Lipid Cntr, Statesville, NC
³ Daiichi Sankyo, Inc., Parsippany, NJ

Lipid-lowering combination therapy is often required to achieve low density lipoprotein cholesterol (LDL-C) goals and to favorably affect other lipid parameters. This is the first double-blind, parallel-group study to evaluate colesevelam (COL), ezetimibe (EZE) and simvastatin (SIM) vs. EZE and SIM alone in subjects with primary hypercholesterolemia (LDL-C 130 mg/dL and triglycerides <400 mg/dL). Subjects (N=85) were randomized 1:1 to COL 3.75 g/d + EZE 10 mg/d or placebo + EZE 10 mg/d for 6 weeks, followed by SIM 20 mg/d to both groups for 4 additional weeks. At week 10, both COL + EZE + SIM and EZE + SIM regimens substantially reduced LDL-C (–57% and –51%, respectively). More subjects achieved an LDL-C goal <70mg/dL with COL + EZE + SIM than with EZE + SIM (52.4% ²²/₄₂ vs 23.3% ¹⁰/₄₃, p<0.01). Both regimens decreased hsCRP, Apo B, LDL subfraction particle concentrations, all lipoprotein ratios, and increased Apo AI, as well as increased HDL and VLDL particle size compared to baseline. COL+EZE+SIM did not change LDL particle size (which actually decreased in the EZE + SIM group to a mild, but significant degree). The use of COL + EZE + SIM did not result in any safety or unexpected tolerability issues. Compliance with study medication was >95% for both groups; >90% of subjects in each group completed the study. COL + EZE + SIM combination therapy was associated with greater attainment of aggressive LDL-C goals, greater improvement in lipoprotein ratios, reduction in LDL particle concentration, and greater increase in Apo AI, and is a useful therapeutic regimen for high-risk patients with primary hypercholesterolemia who are not achieving LDL-C treatment goals.

This Article Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Request Permissions Google Scholar Articles by Bays, H. Articles by Jones, M. PubMed Articles by Bays, H. Articles by Jones, M.