Apabetalone substantially reduces the risk for major cardiovascular events (MACE) among patients with both chronic kidney disease (CKD) and type 2 diabetes mellitus who recently suffered from acute coronary syndrome (ACS), according to study findings presented at the American Society of Nephrology’s Kidney Week 2020 Reimagined virtual conference.1
The findings are based on an analysis of data gathered from the phase 3 BETonMACE clinical trial, in which investigators randomly assigned 2425 patients with type 2 diabetes mellitus and recent ACS to receive apabetalone (1212 patients) or placebo (1206 patients) in addition to standard therapy. Of these patients, 288 (12%) had CKD stage 3 or 4 (defined as an estimated glomerular filtration rate less than 60 mL/min/1.73 m2).
The original report of findings from the BETonMACE trial, published in the Journal of the American Medical Association, found that apabetalone added to standard therapy did not significantly reduce MACE risk compared with placebo in the study population as a whole.2
In the new analysis looking at patients with CKD, apabetalone-treated patients had a significant 50% decreased risk of MACE (cardiovascular death, nonfatal myocardial infarction, or stroke) compared with placebo recipients in adjusted analyses, lead investigator Kamyar Kalantar-Zadeh, MD, PhD, MPH, of the University of California Irvine in Orange California, reported. The apabetalone group also had a significant 74% decreased risk for hospitalization for congestive heart failure.
The patients with CKD were older than those without CKD (71 vs 61 years) and were more likely to be female (42% vs 23%). They also had a significantly longer duration of diabetes (mean 11.3 vs 8.2 years) and higher serum alkaline phosphatase levels (mean 91 vs 81 U/L). The proportion of patients who received metformin was significantly lower in the CKD than no-CKD group (69% vs 84%).
Apabetalone was well tolerated, with similar proportions of patients in both study arms experiencing adverse events (AEs): 71.0% in the apabetalone group and 72.6% among the placebo recipients, Dr Kalantar-Zadeh reported. A significantly lower percentage of patients in the apabetalone group experienced serious AEs (29% vs 43%).
Apabetalone may offer a safe and effective oral pharmacotherapy for reducing the risk of major cardiac events in patients with CKD and type 2 diabetes and prior ACS, he concluded.
- Kalantar-Zadeh K, Schwartz GG, Buhr KA, et al. Effect of apabetalone on major adverse cardiovascular events in patients with CKD, diabetes, and recent acute coronary syndrome: Results from the BETonMACE trial. Presented at: Kidney Week 2020 Reimagined, October 19-25, 2020. Abstract SA-OR40.
- Ray KK, Nichols SJ, Buhr KA, et al. 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. JAMA. 323:1565-1573. doi:10.1001/jama.2020.3308