HDCN Abstract:  ASN Annual Meeting 2020 -- Digital Meeting  

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

ASN Annual Meeting 2020 -- Digital Meeting
J Am Soc Nephrol (Oct) 31:42A 2020

BACKGROUND

Chronic kidney disease (CKD) in type 2 diabetes mellitus (T2DM) patients (pts) is associated with increased cardiovascular disease (CVD) and heart failure risk. We hypothesized that a maladaptive epigenetic response engaging the bromodomain and extraterminal (BET) protein transcription system contributes to excess CVD risk. Hence, the efficacy of BET inhibition (BETi) treatment with apabetalone (APB) was assessed according to presence of CKD in the phase 3 BETonMACE trial.

METHODS

BETonMACE compared APB with placebo in 2425 pts with T2DM and recent acute coronary syndrome. The primary outcome was CV death, non-fatal myocardial infarct or stroke (MACE). Hospitalization for congestive heart failure (HCHF) was a secondary endpoint. Both outcomes were evaluated according to the presence of CKD (estimated GFR <60 mL/min/1.73 m2 at baseline).

RESULTS

CKD pts were older (71 vs. 61 years), more likely female (42% vs. 23%) or non-white (18% vs. 12%), had longer duration of diabetes (mean 11.3 vs. 8.2 years) and higher serum alkaline phosphatase (91 vs. 81 U/L), and were less likely to receive metformin (69% vs. 84%) or SGLT2 inhibitors (6% vs. 13%) (P<0.05 for all). Under placebo, risk of endpoints was higher in CKD vs. non-CKD pts [MACE: 35/164 (21.3%) vs.114/1041 (11.0%), HR=2.40, 95% CI [1.67, 3.44]; HCHF: 14/164 (8.5%) vs. 34/1041 (3.3%), HR=3.19, 95% CI [1.66,6.12]; P<0.001 for both). Under APB treatment, pts with CKD had significant reductions in MACE (HR=0.50, 95% CI [0.26, 0.96], P=0.034) and HCHF (HR=0.26, 95% CI [0.07,0.94], P=0.028) vs. placebo, see Kaplan-Meier figures.

CONCLUSION

CKD patients with T2DM and recent acute coronary syndrome have a high risk of MACE that was substantially reduced with APB BETi in the phase 3 BETonMACE trial.

c Copyright 2020 -2021 American Society of Nephrology. Reproduced with permission.
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