Table 1.
Baseline characteristics of the study population stratified by treatment arm and development of AKI
| Baseline Characteristica | All Patients | Monotherapy Arm | Combination Therapy Arm | |||
|---|---|---|---|---|---|---|
| No AKI, n=1238 | AKI, n=210 | No AKI, n=644 | AKI, n=80 | No AKI, n=594 | AKI, n=130 | |
| Age, yr | 64.7±7.9 | 64.1±7.5 | 64.8±7.8 | 64.3±7.3 | 64.6±7.9 | 63.9±7.7 |
| Men | 1227 (99.1) | 209 (99.5) | 641 (99.5) | 80 (100) | 586 (98.7) | 129 (99.2) |
| Raceb | ||||||
| White | 899 (72.6) | 152 (72.4) | 470 (73.0) | 58 (72.5) | 429 (72.2) | 94 (72.3) |
| Black | 293 (23.7) | 53 (25.2) | 153 (23.8) | 21 (26.3) | 140 (23.6) | 32 (24.6) |
| Other | 43 (3.7) | 5 (2.4) | 21 (3.3) | 1 (1.2) | 25 (4.2) | 4 (3.1) |
| Hispanic ethnicityb | 120 (9.7) | 26 (12.4) | 61 (9.5) | 14 (17.5) | 59 (9.9) | 12 (9.2) |
| Body mass index, kg/m2 | 34.4±6.8 | 35.3±6.9 | 34.2±7.0 | 34.6±6.7 | 34.7±6.7 | 35.8±6.9 |
| Baseline BP, mmHg | ||||||
| Systolic | 137±16 | 135±16 | 137±16 | 134±14 | 137±16 | 136±17 |
| Diastolic | 73±10 | 72±10 | 73±10 | 72±10 | 73±10 | 71±11 |
| Laboratory values at randomization | ||||||
| Serum creatinine, mg/dl | 1.5±0.5 | 1.6±0.5 | 1.5±0.5 | 1.6±0.5 | 1.5±0.5 | 1.6±0.5 |
| eGFR, ml/min per 1.73 m2 | 57.0±18.9 | 51.2±17.1 | 57.6±19.4 | 50.7±15.5 | 56.2±18.3 | 51.6±18.1 |
| Urine albumin excretion, μg/mg creatinine | 794 (419–1620) | 1233 (540–2514) | 780 (416–1654) | 1253 (523–2607) | 820 (419–1533) | 1212 (540–2432) |
| Serum potassium, mEq/L | 4.3±0.5 | 4.4±0.5 | 4.3±0.5 | 4.4±0.6 | 4.3±0.5 | 4.3±0.5 |
| Hemoglobin A1c, % | 7.8±1.2 | 7.8±1.4 | 7.8±1.2 | 7.6±1.5 | 7.8±1.2 | 7.9±1.4 |
| Retinopathy | 526 (42.5) | 93 (44.3) | 274 (42.5) | 36 (45.0) | 252 (42.2) | 57 (43.8) |
| Coronary artery disease | 570 (46.0) | 98 (46.7) | 287 (44.6) | 39 (48.8) | 283 (47.6) | 59 (45.4) |
| Congestive heart failure | 178 (14.4) | 48 (22.9) | 93 (14.4) | 17 (21.3) | 85 (14.3) | 31 (23.8) |
| Diuretic use, % | 868 (70.1) | 158 (75.2) | 451 (70.0) | 59 (73.8) | 417 (70.2) | 99 (76.2) |
Values are reported as means±SD, medians (interquartile ranges), or N (%), with percentages on the basis of total numbers of patients included in each category.
a
All P values for comparisons between treatment arms >0.05; P values for comparisons between patients with and without AKI (all patients) >0.05, except for serum creatinine (P≤0.001), eGFR (P≤0.001), urine albumin excretion (P=0.001), and congestive heart failure (P=0.002).
b
Race and ethnic group were self-reported; the first response is listed when multiple races were reported.