Table 1.
Baseline demographics and other characteristics of the study subjects
| Characteristics | Subjects with moderate hepatic impairment [N = 8] | Subjects with normal hepatic impairment [N = 8] |
|---|---|---|
| Sex, n (%) | ||
| Male | 5 (62.5) | 5 (62.5) |
| Female | 3 (37.5) | 3 (37.5) |
| Age, years | 57.0 (11.1) | 54.5 (10.2) |
| Weight, kg | 80.8 (16.4) | 83.6 (10.2) |
| BMI, kg/m2 | 27.8 (3.9) | 28.1 (2.0) |
| Albumin, g/dl | 35.5 (5.7) | 43.1 (2.0) |
| Bilirubin, µmol/l | 30.2 (15.4) | 9.7 (4.5) |
| Subjects with grade 2–3 prothrombin time, n a | 1 | – |
| Subjects with grade 2–3 encephalopathy, n b | 7 | 0 |
| Subjects with grade 2–3 ascites, n c | 6 | 0 |
Data are expressed as mean (SD) unless otherwise specified
BMI body mass index, SD standard deviation
aOne patient had grade 2, and 7 patients had grade 1
bEncephalopathy: grade 0–normal consciousness, personality, neurological examination, ECG; grade 1–restless, irritable, tremor, impaired handwriting, five cycles/s waves; grade 2–lethargic, time-disorientated, asterixis, ataxia, slow triphasic waves. Seven patients had grade 2 encephalopathy and 1 patient had grade 1
cFive patients had grade 2 ascites, and 1 patient had grade 3