Table 2. Incidence Rates of Composite Cardiovascular Events in the Finerenone in Chronic Kidney Disease and Type 2 Diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial Programme Analysis (FIDELITY) Trial.
eGFR | Composite cardiovascular events (incidence rate per 100 patient-years [95% CI])a | |||||
---|---|---|---|---|---|---|
UACR <300 mg/gb | UACR ≥300 mg/g | |||||
Placebo (n = 2133) | Finerenone (n = 2196) | HR for finerenone vs placebo (95% CI) | Placebo (n = 4370) | Finerenone (n = 4321) | HR for finerenone vs placebo (95% CI) | |
≥90 | 2.38 (1.03-4.29)c | 1.94 (0.78-3.62)c | 0.57 (0.19-1.68)c | 3.78 (2.91-4.75)d | 2.56 (1.86-3.37)d | 0.66 (0.45-0.97)d |
60-<90 | 3.57 (2.77-4.48)c | 2.98 (2.29-3.76)c | 0.82 (0.57-1.16)c | 4.76 (4.11-5.45)d | 4.49 (3.86-5.17)d | 1.01 (0.82-1.23)d |
45-<60 | 4.53 (3.72-5.42)d | 3.26 (2.57-4.03)d | 0.72 (0.54-0.98)d | 5.70 (4.79-6.70)e | 4.69 (3.89-5.56)e | 0.83 (0.65-1.07)e |
30-<45 | 4.93 (4.00-5.95)e | 4.89 (3.98-5.89)e | 0.98 (0.73-1.30)e | 6.03 (5.14-6.99)e | 5.84 (4.97-6.79)e | 0.96 (0.77-1.19)e |
<30 | 6.54 (4.19-9.40)e | 5.85 (3.75-8.41)e | 0.82 (0.44-1.52)e | 8.74 (6.78-10.93)e | 6.89 (5.13-8.90)e | 0.75 (0.51-1.09)e |
Abbreviations: eGFR, estimated glomerular filtration rate; HR, hazard ratio; UACR, urine albumin to creatinine ratio; KDIGO, Kidney Disease: Improving Global Outcomes.
P value for interaction = 0.66.
A total of 230 patients with UACR less than 30 mg/g were included in FIDELITY because of variability between screening and baseline results.
Moderate KDIGO risk category.
High KDIGO risk category.
Very high KDIGO risk category.