DAPA-HF
Trial question
What is the role of dapagliflozin among patients with HFrEF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 4744
4744 patients (1109 female, 3635 male).
Inclusion criteria: adult patients with NYHA class II, III, or IV HF and an ejection fraction < 40%.
Key exclusion criteria: recent treatment with or unacceptable side effects associated with a SGLT 2 inhibitor, T1DM mellitus, symptoms of hypotension or a SBP < 95 mmHg.
Interventions
N=2373 dapagliflozin (at a dose of 10 mg once daily, per oral use).
N=2371 placebo (matching placebo daily).
Primary outcome
Worsening heart failure or CV death
16.3%
21.2%
21.2 %
15.9 %
10.6 %
5.3 %
0.0 %
Dapagliflozin
Placebo
Significant
decrease ▼
NNT = 20
Significant decrease in worsening HF or CV death (16.3% vs. 21.2%; HR 0.74, 95% CI 0.65 to 0.85).
Secondary outcomes
Significant decrease in hospitalization for HF or CV death (16.1% vs. 20.9%; HR 0.75, 95% CI 0.65 to 0.85).
Significant decrease in a first worsening cardiovascular event (10% vs. 13.7%; HR 0.7, 95% CI 0.59 to 0.83).
Significant decrease in death from any cause (11.6% vs. 13.9%; HR 0.83, 95% CI 0.71 to 0.97).
Safety outcomes
No significant differences in adverse events including volume depletion, hypoglycemia, renal dysfunction.
Significant difference in serious renal adverse events (1.6% vs. 2.7%).
Conclusion
In adult patients with NYHA class II, III, or IV HF and an ejection fraction < 40%, dapagliflozin was superior to placebo with respect to worsening HF or CV death.
Reference
John J V McMurray, Scott D Solomon, Silvio E Inzucchi et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008.
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