Effect of the BET Protein Inhibitor, RVX-208, on Progression of Coronary Atherosclerosis: Results of the Phase 2b, Randomized, Double-Blind, Multicenter, ASSURE Trial

Stephen J. Nicholls, Rishi Puri, Kathy Wolski, Christie M. Ballantyne, Philip J. Barter, H. Bryan Brewer, John J P Kastelein, Bo Hu, Kiyoko Uno, Yu Kataoka, Jean Paul R Herrman, B. Merkely, Marilyn Borgman, Steven E. Nissen

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53 Citations (Scopus)

Abstract

Background: Bromodomain and extra-terminal (BET) proteins regulate transcription of lipoprotein and inflammatory factors implicated in atherosclerosis. The impact of BET inhibition on atherosclerosis progression is unknown. Methods: ASSURE was a double-blind, randomized, multicenter trial in which 323 patients with angiographic coronary disease and low high-density lipoprotein cholesterol (HDL-C) levels were randomized in a 3:1 fashion to treatment with the BET protein inhibitor RVX-208 200 mg or placebo for 26 weeks. Plaque progression was measured with serial intravascular ultrasound imaging. Lipid levels, safety, and tolerability were also assessed. Results: During treatment, apolipoprotein (apo)A-I increased by 10.6 % with placebo (P 3 in the placebo group (P = 0.01 compared with baseline) and 4.2 mm3 in the RVX-208 group (P 

Original languageEnglish
Pages (from-to)55-65
Number of pages11
JournalAmerican Journal of Cardiovascular Drugs
Volume16
Issue number1
DOIs
Publication statusPublished - Feb 1 2016

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Cardiology and Cardiovascular Medicine

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    Nicholls, S. J., Puri, R., Wolski, K., Ballantyne, C. M., Barter, P. J., Brewer, H. B., Kastelein, J. J. P., Hu, B., Uno, K., Kataoka, Y., Herrman, J. P. R., Merkely, B., Borgman, M., & Nissen, S. E. (2016). Effect of the BET Protein Inhibitor, RVX-208, on Progression of Coronary Atherosclerosis: Results of the Phase 2b, Randomized, Double-Blind, Multicenter, ASSURE Trial. American Journal of Cardiovascular Drugs, 16(1), 55-65. https://doi.org/10.1007/s40256-015-0146-z