Heart failure & cardiomyopathiesSecondary analysis
Decline in Estimated Glomerular Filtration Rate After Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction
- Secondary analysis of the DELIVER randomised trial
- prespecified analysis
- international multicentre
- DELIVER Aug 2018–Mar 2022; analysed Feb–Oct 2023
Authors' conclusion
Among patients with HFmrEF or HFpEF treated with dapagliflozin, an initial eGFR decline was frequent but not associated with subsequent risk of cardiovascular or kidney events.
Study context
- Population
- Patients with heart failure with mildly reduced ejection fraction (HFmrEF) or HFpEF (EF >40%, estimated glomerular filtration rate (eGFR) ≥25)
- Participants
- 5,788 patients
- Comparison
- Dapagliflozin vs placebo
- Dapagliflozinn = 2,892
- Placebon = 2,896reference
- Primary endpoint
- Frequency of initial eGFR decline (baseline to month 1), and its association with CV (CV death or HF event) and kidney outcomes
- Follow-up
- Baseline to month 1
Primary result
Initial eGFR decline >10%
Odds ratio
1.9
95% CI 1.7–2.1
P < 0.001 for difference
Events by treatment group
Dapagliflozin vs Placebo
OR 1.9 (95% CI 1.7–2.1); P for difference < 0.001
As reported in the abstract
Further findings
| Outcome | aHR (95% CI) | P value | |
|---|---|---|---|
| Primary CV outcome, initial eGFR decline >10% vs ≤10%, by treatment — eGFR decline >10% vs eGFR decline ≤10% · Placebo | 1.33 (1.10–1.62) | ||
| Primary CV outcome, initial eGFR decline >10% vs ≤10%, by treatment — eGFR decline >10% vs eGFR decline ≤10% · Dapagliflozin | 0.90 (0.74–1.09) | ||
| Kidney composite outcome, initial eGFR decline >10%, dapagliflozin-treated · Dapagliflozin | 0.94 (0.49–1.82) | ||
| 0.512Adjusted hazard ratio (log scale) |
Median
| Outcome | Dapagliflozin | Placebo | difference | P value |
|---|---|---|---|---|
| Change in eGFR, baseline to month 1 | −4 (IQR −9–1) | −1 (IQR −6–5) | −3 | P < 0.001 |
- Primary CV outcome, initial eGFR decline >10% vs ≤10%, by treatment: P for interaction = .01
- Primary CV outcome, initial eGFR decline >10% vs ≤10%, by treatment: landmarked at month 1
Primary CV outcome, initial eGFR decline >10% vs ≤10%, by treatment
- Similar associations with alternative thresholds and as a continuous measure
Original publication
Decline in Estimated Glomerular Filtration Rate After Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction. JAMA Cardiol. Published 1 February 2024. doi:10.1001/jamacardio.2023.4664
Summarised from the published abstract; every number is checked against it