Table 1.
Baseline characteristics for the FIDELIO-DKD ‘CREDENCE-like’ subgroupa and CREDENCE
| Characteristics | FIDELIO-DKD ‘CREDENCE-like’ subgroup total (N = 4619) | CREDENCE total (N = 4401) |
|---|---|---|
| Age (years), mean ± SD | 65.3 ± 9.2 | 63.2 ± 9.2 |
| Female, n (%) | 1335 (28.9) | 1494 (33.9) |
| Race, n (%) | ||
| White | 2920 (63.2) | 2931 (66.6) |
| Black/African American | 208 (4.5) | 224 (5.1) |
| Asian | 1171 (25.4) | 877 (19.9) |
| Systolic blood pressure (mmHg), mean ± SD | 138.2 ± 14.1 | 140.0 ± 15.6 |
| Diastolic blood pressure (mmHg), mean ± SD | 76.2 ± 9.5 | 78.3 ± 9.4 |
| BMI (kg/m2), mean ± SD | 31.1 ± 6.0 | 31.3 ± 6.2 |
| Duration of diabetes (years), mean ± SD | 16.1 ± 8.6 | 15.8 ± 8.6 |
| HbA1c (%), mean ± SD | 7.68 ± 1.36 | 8.3 ± 1.3 |
| Serum potassium (mmol/L), mean ± SD | 4.36 ± 0.46 | N/A |
| eGFR (mL/min/1.73 m2), n (%) | 46.5 ± 12.0 | 56.2 ± 18.2 |
| <15 | 0 (0) | 2 (<0.1) |
| ≥15–<30 | 222 (4.8) | 172 (3.9) |
| ≥30–<45 | 2051 (44.4) | 1191 (27.1) |
| ≥45–<60 | 1715 (37.1) | 1266 (28.8) |
| ≥60–<90 | 621 (13.4) | 1558 (35.4) |
| ≥90 | 10 (0.2) | 211 (4.8) |
| UACR (mg/g), median (IQR) | 917 (512–1696) | 927 (463–1833) |
| <30, n (%) | 9 (0.2) | 31 (0.7) |
| 30–≤300, n (%) | 293 (6.3) | 496 (11.3) |
| >300–≤3000, n (%) | 3951 (85.5) | 3371 (76.6) |
| >3000, n (%) | 366 (7.9) | 503 (11.4) |
| History of CV disease, n (%) | ||
| Coronary artery disease | 1398 (30.3) | 1313 (29.8) |
| Cerebrovascular disease | 555 (12.0) | 700 (15.9) |
| Peripheral artery disease | 741 (16.0) | 1046 (23.8) |
| Heart failure | 350 (7.6) | 652 (14.8) |
| Current smoker, n (%) | 695 (15.0) | 639 (14.5) |
| Medication use at baseline, n (%) | ||
| RAAS inhibitor | 4609 (99.8) | 4395 (99.9) |
| Beta-blocker | 2393 (51.8) | 1770 (40.2) |
| Diuretic | 2535 (54.9) | 2057 (46.7) |
| Statin | 3432 (74.3) | 3036 (69.0) |
| Antithrombotic | 2889 (62.4) | 2624 (59.6) |
| Glucose-lowering therapies, n (%) | ||
| Insulin and analogs | 2901 (62.8) | 2884 (65.5) |
| Metformin | 2211 (47.9) | 2545 (57.8) |
| Sulfonylurea | 1101 (23.8) | 1268 (28.8) |
| DPP-4 inhibitor | 1216 (26.3) | 751 (17.1) |
| GLP-1RA | 329 (7.1) | 183 (4.2) |
| SGLT-2i | 231 (5.0) | 2202 (50.0) |
| Alpha glucosidase inhibitor | 269 (5.8) | 139 (3.2) |
| Thiazolidinedione | 184 (4.0) | 136 (3.1) |
a
UACR >300 mg/g and eGFR >30 mL/min/1.73 m2 at baseline.
DPP-4, dipeptidyl peptidase-4; GLP-1RA, glucagon-like peptide‐1 receptor agonist; HbA1c, glycated hemoglobin; RAAS, renin–angiotensin–aldosterone system.
Thirty-five (0.8%) of the patients in the CREDENCE trial were on steroidal MRAs at baseline.