Apabetalone Reduces Risk of Major Cardiovascular Events After Recent ACS in Patients With Diabetes, Kidney Disease

June 17, 2020
By Chris Berrie CEPAGATTI, Italy -- June 16, 2020 -- Apabetalone reduces the risk of major adverse cardiovascular events (MACE) by 50% versus placebo in patients with type 2 diabetes, recent acute coronary syndrome (ACS), and chronic kidney disease (CKD), according to a study presented at the 2020 European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress. The findings come from a subanalysis of the randomised, double-blind, placebo-controlled phase 3 BETonMACE study, which randomised patients with type 2 diabetes and recent ACS (without severe renal impairment) to standard care plus placebo (n = 1,206) or apabetalone 100 mg BID (n = 1,212) for 26 months, after a run-in treatment with atorvastatin or rosuvastatin. Findings from the initial trial showed that, compared with placebo, apabetalone provided non-significant benefit against the primary endpoint of MACE (incidence of CV death or non-fatal myocardial infarction or stroke; 12.4% vs 10.3%; P = .11). However, in a subgroup analysis, patients with stage 3 CKD (estimated glomerular filtration rate 2) benefitted from treatment with apabetalone. In the subgroup of patients with CKD, MACE plus CHF hospitalisation occurred in 12.9% of patients on apabetalone compared with 25% of patients on placebo. For comparison, in the subgroup without CKD, MACE plus CHF hospitalisation occurred in 11.3% and 12.7%, respectively. Rates of adverse events were similar between the placebo and apabetalone groups (71.0% vs 72.6%). “This is the first cardiovascular outcomes trial assessing potential of epigenetic modification in patients with CKD where apabetalone reduced the enormous cardiovascular risk by 50%,” said Kam Kalantar-Zadeh, MD, University of California Irvine, Irvine, California. Funding for this study was provided by Resverlogix Corp. [Presentation title: Effects of the BET Inhibitor Apabetalone on Cardiovascular Events in Patients With Type 2 Diabetes Mellitus and Acute Coronary Syndrome, According to Presence or Absence of Chronic Kidney Disease. a BETonMACE Trial Report. Cardiovascular and Renal Protection. Abstract TO001]