6/28/23, 10:35 PM FIGARO-DKD Pathway Feedback Search Clinical Topics Home Studies FIGARO DKD FIGARO DKD Disease Disease Diabetes mellitus type 2 Diabetic nephropathy 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 N = 7352 69.0% male 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 m , 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 Death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure 14.2 % 14.2 12.4 10 6 % https://web.pathway.md/studies/reciik5jup6NrERRS 1/2 6/28/23, 10:35 PM 10.6 % FIGARO-DKD Pathway 7.1 % Significant decrease 3.5 % NNT = 56 0.0 % Finerenone Placebo Significant decrease in death from cardiovascular causes, nonfatal myocardial infarction, 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 death from cardiovascular causes, nonfatal myocardial infarction, 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. Open reference URL https://web.pathway.md/studies/reciik5jup6NrERRS 2/2