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

Research output: Contribution to journalArticle

45 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

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Multicenter Studies
Coronary Artery Disease
Placebos
Atherosclerosis
Proteins
Apolipoprotein A-I
LDL Cholesterol
HDL Cholesterol
Lipoproteins
Coronary Disease
Ultrasonography
Lipids
Safety
Therapeutics
RVX 208

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Cardiology and Cardiovascular Medicine

Cite this

Effect of the BET Protein Inhibitor, RVX-208, on Progression of Coronary Atherosclerosis : Results of the Phase 2b, Randomized, Double-Blind, Multicenter, ASSURE Trial. / Nicholls, Stephen J.; Puri, Rishi; Wolski, Kathy; Ballantyne, Christie M.; Barter, Philip J.; Brewer, H. Bryan; Kastelein, John J P; Hu, Bo; Uno, Kiyoko; Kataoka, Yu; Herrman, Jean Paul R; Merkely, B.; Borgman, Marilyn; Nissen, Steven E.

In: American Journal of Cardiovascular Drugs, Vol. 16, No. 1, 01.02.2016, p. 55-65.

Research output: Contribution to journalArticle

Nicholls, SJ, Puri, R, Wolski, K, Ballantyne, CM, Barter, PJ, Brewer, HB, Kastelein, JJP, Hu, B, Uno, K, Kataoka, Y, Herrman, JPR, Merkely, B, Borgman, M & Nissen, SE 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, vol. 16, no. 1, pp. 55-65. https://doi.org/10.1007/s40256-015-0146-z
Nicholls, Stephen J. ; Puri, Rishi ; Wolski, Kathy ; Ballantyne, Christie M. ; Barter, Philip J. ; Brewer, H. Bryan ; Kastelein, John J P ; Hu, Bo ; Uno, Kiyoko ; Kataoka, Yu ; Herrman, Jean Paul R ; Merkely, B. ; Borgman, Marilyn ; Nissen, Steven E. / Effect of the BET Protein Inhibitor, RVX-208, on Progression of Coronary Atherosclerosis : Results of the Phase 2b, Randomized, Double-Blind, Multicenter, ASSURE Trial. In: American Journal of Cardiovascular Drugs. 2016 ; Vol. 16, No. 1. pp. 55-65.
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