DAPA-CKD
Trial question
What is the role of dapagliflozin in patients with CKD?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 4304
4304 patients (1425 female, 2879 male).
Inclusion criteria: adult patients with CKD.
Key exclusion criteria: documented diagnosis of T1DM; polycystic kidney disease; lupus nephritis, or ANCA-associated vasculitis; receipt of immunotherapy for kidney disease within 6 months.
Interventions
N=2152 dapagliflozin (10 mg once daily).
N=2152 placebo (matching placebo once daily).
Primary outcome
Composite outcome of sustained decline in estimated glomerular filtration rate of ≥ 50%, end-stage kidney disease, or death from renal or cardiovascular causes
9.2%
14.5%
14.5 %
10.9 %
7.3 %
3.6 %
0.0 %
Dapagliflozin
Placebo
Significant
decrease ▼
NNT = 18
Significant decrease in composite outcome of sustained decline in the eGFR of ≥ 50%, end-stage kidney disease, or death from renal or cardiovascular causes (9.2% vs. 14.5%; HR 0.61, 95% CI 0.51 to 0.72).
Secondary outcomes
Significant decrease in composite outcome of sustained decline in the eGFR of ≥ 50%, end-stage kidney disease, or death from renal causes (6.6% vs. 11.3%; HR 0.56, 95% CI 0.45 to 0.68).
Significant decrease in composite outcome of CV death or hospitalization for HF (4.6% vs. 6.4%; HR 0.71, 95% CI 0.55 to 0.92).
Significant decrease in death from any cause (4.7% vs. 6.8%; HR 0.69, 95% CI 0.53 to 0.88).
Safety outcomes
No significant differences in renal-related adverse event, amputation, fracture.
Significant difference in serious adverse event (29.5% vs. 33.9%).
Conclusion
In adult patients with CKD, dapagliflozin was superior to placebo with respect to the composite outcome of sustained decline in the eGFR of ≥ 50%, end-stage kidney disease, or death from renal or cardiovascular causes.
Reference
Hiddo J L Heerspink, Bergur V Stefánsson, Ricardo Correa-Rotter et al. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446.
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