{"id":"6d6698f980de","type":"article","url":"https://hartvaat.nl/2020/04/28/apabetalone-en-cv-events-bij-acs-met-diabetes-type-2-jama-betonmace/","title":"Apabetalone en CV-events bij ACS met diabetes type 2: JAMA BETonMACE","title_en":"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.","category":"preventie","category_label":"Preventie","professions":["apotheker","cardioloog","internist"],"tags":["diabetes-type-2","soul-trial"],"journal":"JAMA","doi":"10.1001/jama.2020.3308","source_url":"https://doi.org/10.1001/jama.2020.3308","authors":["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"],"significance":7,"published":"2020-04-28","source_date":"2020-04-28","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/diabetes-en-cardiovasculair-risico/","https://hartvaat.nl/kennis/cardiometabool/diabetes-type-1-en-hart/"],"congress":"","summary_en":"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.","created":"2026-07-03T10:28:32Z","updated":"2026-07-03T13:27:42Z","licence":"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.","body_markdown":"JAMA BETonMACE trial van apabetalone (BET-remmer) bij ACS met diabetes type 2. Negatief op primair eindpunt maar nieuw mechanisme.","abstract_original":"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."}