Apabetalone and hospitalization for heart failure in patients following an acute coronary syndrome: a prespecified analysis of the BETonMACE study
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Key result
Apabetalone cuts first HF hospitalization ~41% vs. placebo in T2D with recent ACS.
- HR 0.59
- 95% CI 0.38-0.94
- P=0.03
- n=2,425
Why the study?
Patients with diabetes and ACS are at high risk for heart failure, but the effect of the selective BET protein inhibitor apabetalone on post-ACS heart failure events is not known.
Does apabetalone reduce hospitalization for heart failure in patients with recent acute coronary syndrome and diabetes?
Population
2425 patients with recent ACS and diabetes
Comparison
Apabetalone vs placebo
Design
Prespecified secondary analysis of a double-blind randomized phase 3 trial
Follow-up
Average 26 months
Authors
Discussion
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Member takes
Implication
Apabetalone reduces first HF hospitalization in recent ACS with diabetes; extends BET inhibition data to heart failure prevention.
Study Design
Type
RCT (n=2,425)
Blinding
Double-blind
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does apabetalone reduce hospitalization for heart failure in patients with recent acute coronary syndrome and diabetes?
P
Population
2,425 patients with type 2 diabetes and a recent acute coronary syndrome, treated with high-intensity statins, followed for an average of 26 months.
I
Intervention
Apabetalone
C
Comparator
Placebo
O
Outcome
First hospitalization for congestive heart failurehard clinical
Main Result
Hazard Ratio: 0.59 (95% CI 0.38–0.94)
Absolute Event Rate: 2.4% vs 4%
p-value: p=0.03
In patients with type 2 diabetes and recent ACS, apabetalone treatment was associated with a significantly lower rate of hospitalization for heart failure.
Limitations
- Measures of cardiac function and circulating biomarkers associated with heart failure were not collected systematically.
- The primary endpoint of the main BETonMACE trial failed to meet statistical significance, making this secondary finding exploratory.
- The study was performed exclusively in patients with type 2 diabetes.
- There was little background use of SGLT2 inhibitors.
- Prior history of heart failure was collected by voluntary patient reporting rather than a prospective question.
Cite This Study
Nicholls et al. (2021) conducted an RCT in Acute coronary syndrome and type 2 diabetes (n=2,425). Apabetalone vs. Placebo was evaluated on First hospitalization for heart failure (HR 0.59, 95% CI 0.38-0.94, p=0.03). Apabetalone reduced the rate of first hospitalization for heart failure compared to placebo (HR 0.59) in patients with type 2 diabetes and recent acute coronary syndrome.
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