Table 1.

Baseline demographic, clinical, and biochemical characteristics

CharacteristicAvosentan 25 mg (n = 455)Avosentan 50 mg (n = 478)Placebo (n = 459)P
Avosentan 25 mg versus PlaceboAvosentan 50 mg versus Placebo
Age (years; mean ± SD)61.2 ± 8.861.0 ± 9.160.8 ± 8.90.7880.976
Female (n [%])140 (30.8)157 (32.8)155 (33.8)0.5120.819
Disease history (n [%])
    coronary artery disease143 (31.4)135 (28.2)149 (32.5)0.8160.128
    CHF66 (14.5)69 (14.4)62 (13.5)0.1890.432
    stroke or transient ischemic attack39 (8.6)33 (6.9)40 (8.7)0.7630.140
    peripheral vascular disease37 (8.1)31 (6.5)26 (5.7)0.0640.890
    hypertension409 (89.9)427 (89.3)412 (89.9)0.7420.984
    current smoking2 (0.4)3 (0.6)4 (0.9)0.3950.459
    diabetic retinopathy183 (40.0)191 (40.2)167 (36.4)0.2300.329
Physical examination
    SBP (mmHg; mean ± SD)137.1 ± 13.8137.0 ± 14.3135.4 ± 15.10.1620.299
    DBP (mmHg; mean ± SD)77.9 ± 9.277.5 ± 8.677.2 ± 9.50.3580.573
    BMI (kg/m2; mean ± SD)29.9 ± 6.230.4 ± 6.530.1 ± 6.20.9750.193
    body weight (kg; mean ± SD)84.5 ± 21.085.0 ± 21.084.0 ± 19.90.9600.347
    edema (n [%])70 (15.4)58 (12.1)68 (14.8)0.4460.938
Laboratory results
    HbA1c (%; mean ± SD)8.0 ± 1.58.1 ± 1.68.0 ± 1.50.9270.989
    creatinine (μmol/L; mean ± SD)185.1 ± 50.2186.9 ± 50.8187.7 ± 50.90.9900.999
    eGFR (ml/min per 1.73 m2; mean ± SD)33.8 ± 11.233.2 ± 10.933.0 ± 10.60.8750.992
    ACR (mg/mmol)0.9790.408
        median160.9166.5173.2
        IQR82.45–274.3585.80–284.5089.85–319.45
    hemoglobin (g/L; mean ± SD)122.6 ± 17.7121.3 ± 17.4121.0 ± 16.60.5020.944
Medication (n [%])
    insulin315 (69.2)315 (65.9)291 (63.4)0.0570.943
    glitazones54 (11.9)50 (10.4)57 (12.4)0.6330.804
    ACEIs308 (67.7)293 (61.3)273 (59.5)0.1670.269
    ARBs195 (42.9)207 (43.3)182 (39.7)0.3400.980
    dihydropyridine calcium channel blockers204 (44.8)204 (42.7)207 (45.1)0.5290.206
    β blockers178 (39.1)156 (32.6)176 (38.3)0.8030.138
    diuretics293 (64.4)309 (64.6)297 (64.7)0.9350.555
    loop diuretics200 (44.0)231 (48.3)208 (45.3)0.8740.741
    statins257 (56.5)264 (55.2)275 (59.9)0.1760.187
  • BP was measured in the sitting position; first morning urine was provided on 3 consecutive days and the mean value is represented. Heart failure New York Heart Association stage III or IV CHF was an exclusion criterion. BMI, body mass index; DBP, diastolic BP; HbA1c, glycosylated hemoglobin; IQR, interquartile range; SBP, systolic BP.