DELIVER
Trial question
What is the role of dapagliflozin in patients with HFmrEF or HFpEF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 6263
6263 patients (2747 female, 3516 male)
Inclusion criteria: patients with HF and a LVEF > 40%
Key exclusion criteria: T1DM mellitus; receipt of SGLT 2 inhibitor within 4 weeks of randomization; or previous intolerance to SGLT 2 inhibitor; impaired kidney function
Interventions
N=3131 dapagliflozin (at a dose of 10 mg/day plus usual therapy)
N=3132 placebo (matching placebo plus usual therapy)
Primary outcome
Worsening heart failure or cardiovascular death
16.4
19.5
19.5 %
14.6 %
9.8 %
4.9 %
0.0 %
Dapagliflozin
Placebo
Significant
decrease ▼
NNT = 32
Significant decrease in worsening HF or cardiovascular death (16.4% vs. 19.5%; HR 0.82, 95% CI 0.73 to 0.92)
Secondary outcomes
Significant decrease in the incidence of worsening HF events and cardiovascular deaths (11.8 events/100 person-year vs. 15.3 events/100 person-year; RR 0.77, 95% CI 0.67 to 0.89)
No significant difference in death from any cause (15.9% vs. 16.8%; HR 0.94, 95% CI 0.83 to 1.07)
No significant difference in cardiovascular death (7.4% vs. 8.3%; HR 0.88, 95% CI 0.74 to 1.05)
Safety outcomes
No significant difference in adverse events and serious adverse events.
Conclusion
In patients with HF and a LVEF > 40%, dapagliflozin was superior to placebo with respect to worsening HF or cardiovascular death.
Reference
Scott D Solomon, John J V McMurray, Brian Claggett et al. Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2022 Sep 22;387(12):1089-1098.
Open reference URL