DELIVER (post-hoc analysis)
Trial question
What is the role of dapagliflozin in patients with HFimpEF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 1151
1151 patients (377 female, 774 male).
Inclusion criteria: patients with HFimpEF.
Key exclusion criteria: T1DM; BMI > 50 kg/m²; stroke or TIA within 12 weeks prior to enrollment; receiving therapy with SGLT-2 inhibitor therapy within 4 weeks prior to randomization or previous intolerance to SGLT-2 inhibitor therapy.
Interventions
N=572 dapagliflozin (at a dose of 10 mg once daily).
N=579 placebo (matching placebo).
Primary outcome
Non-CV death
56 events
47 events
56.0 events
42.0 events
28.0 events
14.0 events
0.0 events
Dapagliflozin
Placebo
No significant
difference ↔
No significant difference in non-CV death (56 events vs. 47 events; HR 1.18, 95% CI 0.8 to 1.74).
Secondary outcomes
Borderline significant decrease in CV death (34 events vs. 53 events; HR 0.62, 95% CI 0.41 to 0.96).
No significant difference in HF death (15 events vs. 14 events; HR 1.07, 95% CI 0.51 to 2.21).
Significant decrease in sudden CV death (10 events vs. 26 events; HR 0.38, 95% CI 0.18 to 0.79).
Conclusion
In patients with HFimpEF, dapagliflozin was not superior to placebo with respect to a non-CV death.
Reference
Orly Vardeny, Akshay S Desai, Pardeep S Jhund et al. Dapagliflozin and Mode of Death in Heart Failure With Improved Ejection Fraction: A Post Hoc Analysis of the DELIVER Trial. JAMA Cardiol. 2024 Mar 1;9(3):283-289.
Open reference URL