FIGARO-DKD
Trial question
What is the role of finerenone in patients with CKD and T2DM?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 7352
7352 patients (2247 female, 5105 male).
Inclusion criteria: patients with T2DM and CKD treated with a renin-angiotensin system inhibitor at the maximum dose.
Key exclusion criteria: urinary albumin-to-creatinine ratio of 300-5,000 and an eGFR of 25 to < 60 mL/min/1.73 m², symptomatic chronic HFrEF.
Interventions
N=3686 finerenone (oral dose of 10 or 20 mg tablet once daily).
N=3666 placebo (oral dose of matching placebo once daily).
Primary outcome
CV death, nonfatal MI, nonfatal stroke, or hospitalization for heart failure
12.4%
14.2%
14.2 %
10.6 %
7.1 %
3.5 %
0.0 %
Finerenone
Placebo
Significant
decrease ▼
NNT = 55
Significant decrease in CV death, nonfatal MI, nonfatal stroke, or hospitalization for HF (12.4% vs. 14.2%; HR 0.87, 95% CI 0.76 to 0.98).
Secondary outcomes
No significant difference in kidney failure, ≥ 40% sustained decline in the eGFR, or death from renal causes (9.5% vs. 10.8%; HR 0.87, 95% CI 0.76 to 1.01).
No significant difference in hospitalization for any cause (42.7% vs. 43.8%; HR 0.97, 95% CI 0.9 to 1.04).
No significant difference in death from any cause (9% vs. 10.1%; HR 0.89, 95% CI 0.77 to 1.04).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In patients with T2DM and CKD treated with a renin-angiotensin system inhibitor at the maximum dose, finerenone was superior to placebo with respect to CV death, nonfatal MI, nonfatal stroke, or hospitalization for HF.
Reference
Bertram Pitt, Gerasimos Filippatos, Rajiv Agarwal et al. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021 Dec 9;385(24):2252-2263.
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