Efficacy and Safety of a Novel Oral Inducer of Apolipoprotein A-I Synthesis in Statin-Treated Patients With Stable Coronary Artery Disease A Randomized Controlled Trial》.pdf

Journal of the American College of Cardiology Vol. 57, No. 9, 2011 © 2011 by the American College of Cardiology Foundation ISSN 0735-1097/$36.00 Published by Elsevier Inc. doi:10.1016/j.jacc.2010.11.015 EXPEDITED PUBLICATIONS Efficacy and Safety of a Novel Oral Inducer of Apolipoprotein A-I Synthesis in Statin-Treated Patients With Stable Coronary Artery Disease A Randomized Controlled Trial Stephen J. Nicholls, MBBS, PHD,* Allan Gordon, MD, PHD,† Jan Johansson, MD, PHD,† Kathy Wolski, MPH,* Christie M. Ballantyne, MD,‡ John J. P. Kastelein, MD, PHD,§ Allen Taylor, MD, Marilyn Borgman, RN, BSN,* Steven E. Nissen, MD* Cleveland, Ohio; Calgary, Alberta, Canada; Houston, Texas; Amsterdam, the Netherlands; and Washington, DC Objectives The purpose of this study was to investigate the safety, tolerability, and efficacy of RVX-208, the first oral agent designed to enhance apolipoprotein (apo) A-I synthesis. Background No agent that selectively induces synthesis of apoA-I has reached an advanced stage of clinical development. Methods A total of 299 statin-treated patients with coronary artery disease were treated with placebo or with RVX-208 at a dose of 50, 100, or 150 mg twice daily for 12 weeks. Changes in lipid-related biomarkers, in addition to safety and tolerability, of RVX-208 were investigated. Results For each dose of RVX-208, individual pairwise comparisons of apoA-I