EMPA-KIDNEY
Trial question
What is the role of empagliflozin in patients with CKD?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 6609
6609 patients (2192 female, 4417 male)
Inclusion criteria: patients with CKD with an eGFR ≥ 20 and < 45 mL/min/1.73 m², or ≥ 45 and < 90 mL/min/1.73 m² with a urinary albumin-to-creatinine ratio ≥ 200
Key exclusion criteria: polycystic kidney disease; receipt of kidney transplant
Interventions
N=3304 empagliflozin (at a dose of 10 mg/day)
N=3305 placebo (matching placebo)
Primary outcome
Progression of kidney disease or death from cardiovascular causes
13.1
16.9
16.9 %
12.7 %
8.4 %
4.2 %
0.0 %
Empagliflozin
Placebo
Significant
decrease ▼
NNT = 26
Significant decrease in progression of kidney disease or death from cardiovascular causes (13.1% vs. 16.9%; HR 0.72, 95% CI 0.64 to 0.82)
Secondary outcomes
No significant difference in hospitalization for HF or death from cardiovascular causes (4% vs. 4.6%; HR 0.84, 95% CI 0.67 to 1.07)
Significant decrease in the incidence of hospitalization for any cause (24.8 events /100 py vs. 29.2 events /100 py; HR 0.86, 95% CI 0.78 to 0.95)
No significant difference in death from any cause (4.5% vs. 5.1%; HR 0.87, 95% CI 0.7 to 1.08)
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients with CKD with an eGFR ≥ 20 and < 45 mL/min/1.73 m², or ≥ 45 and < 90 mL/min/1.73 m² with a urinary albumin-to-creatinine ratio ≥ 200, empagliflozin was superior to placebo with respect to progression of kidney disease or death from cardiovascular causes.
Reference
EMPA-KIDNEY Collaborative Group, William G Herrington, Natalie Staplin et al. Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2023 Jan 12;388(2):117-127.
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