Effect of Apabetalone Added to Standard Therapy on Major Adverse Cardiovascular Events in Patients With Recent Acute Coronary Syndrome and Type 2 Diabetes: A Randomized Clinical Trial

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Kausik K Ray 1, Stephen J Nicholls 2, Kevin A Buhr 3, Henry N Ginsberg 4, Jan O Johansson 5, Kamyar Kalantar-Zadeh 6, Ewelina Kulikowski 5, Peter P Toth 7, Norman Wong 5, Michael Sweeney 5, Gregory G Schwartz 8, BETonMACE Investigators and Committees

Main idea: Among patients with recent acute coronary syndrome, type 2 diabetes, and low high-density lipoprotein cholesterol levels, the selective bromodomain and extraterminal protein inhibitor apabetalone added to standard therapy did not significantly reduce the risk of major adverse cardiovascular events.

Abstract

Importance: Bromodomain and extraterminal proteins are epigenetic regulators of gene transcription. Apabetalone is a selective bromodomain and extraterminal protein inhibitor targeting bromodomain 2 and is hypothesized to have potentially favorable effects on pathways related to atherothrombosis. Pooled phase 2 data suggest favorable effects on clinical outcomes.

Objective: To test whether apabetalone significantly reduces major adverse cardiovascular events.

Design, setting, and participants: A randomized, double-blind, placebo-controlled trial, conducted at 190 sites in 13 countries. Patients with acute coronary syndrome in the preceding 7 to 90 days, type 2 diabetes, and low high-density lipoprotein cholesterol levels were eligible for enrollment, which started November 11, 2015, and ended July 4, 2018, with end of follow-up on July 3, 2019.

Interventions: Patients were randomized to receive apabetalone, 100 mg orally twice daily), or matching placebo in addition to standard care.

Main outcomes and measures: The primary outcome was a composite of time to the first occurrence of cardiovascular death. More patients allocated to apabetalone than placebo discontinued study drug. During the median follow-up of 26.5 months, 274 primary end points occurred: 125 (10.3%) in apabet Alone-treated patients and 149 (12.4%) in placebo-treated Patients. The study was published in the Journal of Cardiovascular Research.

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