DAPA-CKD (post-hoc analysis)
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 = 4292
4292 patients (1419 female, 2873 male)
Inclusion criteria: patients with CKD with and without anemia
Key exclusion criteria: T1DM, polycystic kidney disease, lupus nephritis, or antineutrophil cytoplasmic antibody-associated vasculitis
Interventions
N=2147 dapagliflozin (at a dose of 10 mg/day)
N=2145 placebo (matching placebo daily)
Primary outcome
Improvement in hematocrit during follow-up
2
-0.3
2.0 %
1.5 %
1.0 %
0.5 %
0.0 %
-0.5 %
Dapagliflozin
Placebo
Significant
increase ▲
NNT = 43
Significant increase in improvement in hematocrit during follow-up (2% vs. -0.3%; AD 2.3%, 95% CI 2.1 to 2.5)
Secondary outcomes
Borderline significant increase in correction of anemia in patients with anemia (53.3% vs. 29.4%; HR 2.29, 95% CI 1.96 to 2.68)
Borderline significant decrease in incident anemia in patients without anemia (10.4% vs. 23.7%; HR 0.39, 95% CI 0.31 to 0.48)
Borderline significant increase in the percentage of patients achieving ≥ 3% improvement in hematocrit (69% vs. 37%; HR 2.57, 95% CI 2.35 to 2.81)
Safety outcomes
No significant difference in adverse events.
Significant difference in anemia-related adverse events (2.2% vs. 3.8%).
Conclusion
In patients with CKD with and without anemia, dapagliflozin was superior to placebo with respect to improvement in hematocrit during follow-up.
Reference
Akihiko Koshino, Meir Schechter, Glenn M Chertow et al. Dapagliflozin and Anemia in Patients with Chronic Kidney Disease. NEJM Evid. 2023 Jun;2(6):EVIDoa2300049.
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