Table 1.

Baseline characteristics of the study population stratified by treatment arm and development of AKI

Baseline CharacteristicaAll PatientsMonotherapy ArmCombination Therapy Arm
No AKI, n=1238AKI, n=210No AKI, n=644AKI, n=80No AKI, n=594AKI, n=130
Age, yr64.7±7.964.1±7.564.8±7.864.3±7.364.6±7.963.9±7.7
Men1227 (99.1)209 (99.5)641 (99.5)80 (100)586 (98.7)129 (99.2)
Raceb
 White899 (72.6)152 (72.4)470 (73.0)58 (72.5)429 (72.2)94 (72.3)
 Black293 (23.7)53 (25.2)153 (23.8)21 (26.3)140 (23.6)32 (24.6)
 Other43 (3.7)5 (2.4)21 (3.3)1 (1.2)25 (4.2)4 (3.1)
Hispanic ethnicityb120 (9.7)26 (12.4)61 (9.5)14 (17.5)59 (9.9)12 (9.2)
Body mass index, kg/m234.4±6.835.3±6.934.2±7.034.6±6.734.7±6.735.8±6.9
Baseline BP, mmHg
 Systolic137±16135±16137±16134±14137±16136±17
 Diastolic73±1072±1073±1072±1073±1071±11
Laboratory values at randomization
 Serum creatinine, mg/dl1.5±0.51.6±0.51.5±0.51.6±0.51.5±0.51.6±0.5
 eGFR, ml/min per 1.73 m257.0±18.951.2±17.157.6±19.450.7±15.556.2±18.351.6±18.1
 Urine albumin excretion, μg/mg creatinine794 (419–1620)1233 (540–2514)780 (416–1654)1253 (523–2607)820 (419–1533)1212 (540–2432)
 Serum potassium, mEq/L4.3±0.54.4±0.54.3±0.54.4±0.64.3±0.54.3±0.5
 Hemoglobin A1c, %7.8±1.27.8±1.47.8±1.27.6±1.57.8±1.27.9±1.4
Retinopathy526 (42.5)93 (44.3)274 (42.5)36 (45.0)252 (42.2)57 (43.8)
Coronary artery disease570 (46.0)98 (46.7)287 (44.6)39 (48.8)283 (47.6)59 (45.4)
Congestive heart failure178 (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.