EMPA-KIDNEY (long-term follow-up)
Trial question
What are the long-term effects of empagliflozin in patients with CKD at risk for progression?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
34.0% female
66.0% male
N = 4891
4891 patients (1664 female, 3227 male).
Inclusion criteria: patients with CKD at risk for progression.
Key exclusion criteria: polycystic kidney disease; previous or scheduled bariatric surgery; ketoacidosis in the past 5 years; symptomatic hypotension; hypersensitivity to empagliflozin; intravenous immunosuppressive therapy in the last 3 months; T1DM.
Interventions
N=2472 empagliflozin (at a dose of 10 mg once daily in active trial period; in post-trial period, no trial empagliflozin administration, but prescription of open-label SGLT inhibitors including open-label empagliflozin allowed).
N=2419 placebo (matching placebo once daily in active trial period; in post-trial period, no trial placebo administration, but prescription of open-label SGLT inhibitors including open-label empagliflozin allowed).
Primary outcome
Kidney disease progression or CV death
26.2%
30.3%
30.3 %
22.7 %
15.2 %
7.6 %
0.0 %
Empagliflozin
Placebo
Significant
decrease ▼
NNT = 24
Significant decrease in kidney disease progression or CV death (26.2% vs. 30.3%; HR 0.79, 95% CI 0.72 to 0.87).
Secondary outcomes
Significant decrease in kidney disease progression (23.5% vs. 27.1%; HR 0.79, 95% CI 0.72 to 0.87).
Significant decrease in death from any cause or ESRD (16.9% vs. 19.6%; HR 0.81, 95% CI 0.72 to 0.9).
Significant decrease in ESRD (9% vs. 11.3%; HR 0.74, 95% CI 0.64 to 0.87).
Conclusion
In patients with CKD at risk for progression, empagliflozin was superior to placebo with respect to kidney disease progression or CV death.
Reference
EMPA-KIDNEY Collaborative Group, William G Herrington, Natalie Staplin et al. Long-Term Effects of Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2024 Oct 25:10.1056/NEJMoa2409183. Online ahead of print.
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