# Apabetalone en CV-events bij ACS met diabetes type 2: JAMA BETonMACE

*geplaatst 2020-04-28 · Preventie · JAMA · doi 10.1001/jama.2020.3308 · https://hartvaat.nl/2020/04/28/apabetalone-en-cv-events-bij-acs-met-diabetes-type-2-jama-betonmace/*

JAMA BETonMACE trial van apabetalone (BET-remmer) bij ACS met diabetes type 2. Negatief op primair eindpunt maar nieuw mechanisme.

## English: 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.

The BETonMACE trial showed that apabetalone, a bromodomain and extraterminal protein inhibitor, did not significantly reduce MACE in patients with ACS and type 2 diabetes. The novel epigenetic mechanism represents an innovative but unproven cardiovascular prevention approach.

## Abstract (original, from the publication)

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 an 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 (1:1) to receive apabetalone, 100 mg orally twice daily (n = 1215), or matching placebo (n = 1210) in addition to standard care. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of time to the first occurrence of cardiovascular death, nonfatal myocardial infarction, or stroke. RESULTS: Among 2425 patients who were randomized (mean age, 62 years; 618 women [25.6%]), 2320 (95.7%) had full ascertainment of the primary outcome. During a median follow-up of 26.5 months, 274 primary end points occurred: 125 (10.3%) in apabetalone-treated patients and 149 (12.4%) in placebo-treated patients (hazard ratio, 0.82 [95% CI, 0.65-1.04]; P = .11). More patients allocated to apabetalone than placebo discontinued study drug (114 [9.4%] vs 69 [5.7%]) for reasons including elevations of liver enzyme levels (35 [2.9%] vs 11 [0.9%]). CONCLUSIONS AND RELEVANCE: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02586155.

Auteurs: Kausik K Ray, Stephen J Nicholls, Kevin A Buhr, Henry N Ginsberg, Jan O Johansson, Kamyar Kalantar-Zadeh, Ewelina Kulikowski, Peter P Toth, Norman Wong, Michael Sweeney, Gregory G Schwartz

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Bron: JAMA, https://doi.org/10.1001/jama.2020.3308. Bijgewerkt 2026-07-03T13:27:42Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.