Heart failure & cardiomyopathiesMeta-analysis
Effect of Dapagliflozin on Health Status and Quality of Life Across the Spectrum of Ejection Fraction: Participant-Level Pooled Analysis from the DAPA-HF and DELIVER Trials
- Pooled participant-level analysis of the DAPA-HF and DELIVER randomised trials
- double-blind
- placebo-controlled
- global
- pre-specified secondary outcome
Authors' conclusion
In participant-level pooled analyses of DAPA-HF and DELIVER, dapagliflozin improved all key domains of health status across the full range of LVEF. Clinically meaningful improvements in health status were also observed consistently across LVEF, including in those with LVEF >60%.
Study context
- Population
- Symptomatic HF with elevated natriuretic peptides across the full left ventricular ejection fraction (LVEF) spectrum (DAPA-HF LVEF ≤40%, DELIVER LVEF >40%)10,238 with baseline KCCQ-TSS
- Participants
- 11,007 participants
- Comparison
- Dapagliflozin vs placebo
- Outcome
- KCCQ total symptom score (TSS) and other KCCQ domains by continuous LVEF
- Follow-up
- 8 months
Pooled result
As reported in the abstract
Benefits of dapagliflozin vs placebo consistent across full LVEF range (total symptom score (TSS), clinical summary score (CSS), overall summary score (OSS), physical limitation score (PLS))
pinteraction = 0.19, 0.10, 0.12, 0.10
Further pooled results
Clinically meaningful deterioration in KCCQ-TSS (≥5 point decline), by LVEF
- Overall: Dapagliflozin vs Placebo
- 21% vs. 23%
- LVEF ≤40%: Dapagliflozin vs Placebo
- 21% vs. 29%
- LVEF 41-60%: Dapagliflozin vs Placebo
- 21% vs. 26%
- LVEF >60%: Dapagliflozin vs Placebo
- 22% vs. 27%
- interaction P = 0.20 (continuous LVEF)
At least small improvement in KCCQ-TSS (≥5 point increase), by LVEF
- Overall: Dapagliflozin vs Placebo
- 50% vs. 45%
- LVEF ≤40%: Dapagliflozin vs Placebo
- 48% vs. 41%
- LVEF 41-60%: Dapagliflozin vs Placebo
- 51% vs. 49%
- LVEF >60%: Dapagliflozin vs Placebo
- 53% vs. 45%
- NNT for ≥5 point improvement in KCCQ-TSS across LVEF spectrum
- 20
- interaction P = 0.64 (continuous LVEF)
Health status before HF hospitalization · up to 3 months prior
- Kansas City Cardiomyopathy Questionnaire (KCCQ) decline preceding HF hospitalization, in both trials (points)
- ∼10
Original publication
Summarised from the published abstract; every number is checked against it