Variables | Placebo (N = 76) | Tolvaptan 7.5 mg (N = 153) | Tolvaptan 15 mg (N = 301) | P value |
---|---|---|---|---|
Age (years, mean ± SD) | 54.4 ± 12.3 | 53.8 ± 10.4 | 54.2 ± 10.9 | 0.847†|
Gender male (N, %) | 54 (71.1) | 109 (71.2) | 215 (71.4) | 1.000‡ |
Body weight kg (mean ± SD) | 63.5 ± 12.8 | 60.6 ± 10.1 | 62.9 ± 12.0 | 0.008†|
Abdominal circumference (cm, mean ± SD) | 87.8 ± 12.0 | 84.7 ± 9.0 | 87.9 ± 11.1 | < 0.001†|
Severity of lower limb edema (N, %) |  |  |  | 0.837§ |
 Non | 50 (65.8) | 106 (69.3) | 212 (70.4) |  |
 Mild | 17 (22.4) | 28 (18.3) | 59 (19.6) |  |
 Moderate | 7 (9.2) | 16 (10.5) | 23 (7.6) |  |
 Severe | 2 (2.6) | 3 (2.0) | 7 (2.3) |  |
Duration of cirrhosis (day, mean ± SD) | 842.8 ± 1137.5 | 916.8 ± 1622.6 | 894.8 ± 1460.9 | 0.925†|
Etiology of liver cirrhosis (N, %) |  |  |  | 0.371§ |
 Hepatitis B | 49 (64.5) | 101 (66.0) | 200 (66.4) |  |
 Hepatitis C | 9 (11.8) | 9 (5.9) | 18 (6.0) |  |
 Alcoholic hepatitis | 12 (15.8) | 31 (20.3) | 57 (18.9) |  |
 Primary biliary cirrhosis | 3 (3.9) | 3 (2.0) | 7 (2.3) |  |
 Unknown | 3 (3.9) | 7 (4.6) | 16 (5.3) |  |
 Others | 5 (6.6) | 13 (8.5) | 25 (8.3) |  |
Child–Pugh class (N, %) |  |  |  | 0.702§ |
 Class A | 1 (1.3) | 2 (1.3) | 7 (2.3) |  |
 Class B | 48 (63.2) | 96 (62.7) | 190 (63.1) |  |
 Class C | 27 (35.5) | 55 (35.9) | 104 (34.6) |  |
Albumin concentration (g/dL, mean ± SD) | 3.0 ± 0.4 | 3.1 ± 0.5 | 3.0 ± 0.5 | 0.218†|
Albumin level (N, %) |  |  |  | 0.430§ |
 > 3.5 g/dL | 8 (10.5) | 30 (19.6) | 52 (17.3) |  |
 2.8–3.5 g/dL | 48 (63.2) | 85 (55.6) | 161 (53.5) |  |
 < 2.8 g/dL | 20 (26.3) | 38 (24.8) | 88 (29.2) |  |
Serum sodium (mmol/L, mean ± SD) | 137.7 ± 4.4 | 136.7 ± 5.1 | 136.9 ± 4.8 | 0.322†|
 Serum sodium < 135 mmol/L (N, %) | 17 (22.4) | 41 (26.8) | 85 (28.2) | 0.587§ |
Serum potassium (mmol/L, mean ± SD) | 3.9 ± 0.5 | 4.1 ± 0.6 | 4.0 ± 0.5 | 0.022†|
Scr (mg/dL, mean ± SD) | 0.8 ± 0.2 | 0.8 ± 0.3 | 0.9 ± 0.3 | 0.276†|
BUN (mmol/L, mean ± SD) | 6.2 ± 3.0 | 6.3 ± 3.4 | 6.8 ± 3.6 | 0.264†|
TB (µmol/L, mean ± SD) | 43.8 ± 42.1 | 49.2 ± 57.2 | 43.6 ± 47.7 | 0.509†|
AST (IU/L, mean ± SD) | 67.4 ± 54.9 | 68.8 ± 56.9 | 66.0 ± 54.2 | 0.875†|
ALT/GPT (IU/L, mean ± SD) | 42.2 ± 27.1 | 43.1 ± 37.7 | 44.2 ± 39.3 | 0.899†|
Dose of conventional diuretics | Â | Â | Â | Â |
Loop diuretics, furosemide equivalent (N, %) | 73 (96.1) | 144 (94.1) | 278 (92.4) | 0.583§ |
 20–39 mg/day | 22 (30.1) | 44 (30.6) | 78 (28.1) |  |
 40–59 mg/day | 23 (31.5) | 51 (35.4) | 106 (38.1) |  |
 60–79 mg/day | 11 (15.1) | 18 (12.5) | 36 (12.9) |  |
 80–99 mg/day | 8 (11.0) | 17 (11.8) | 37 (13.3) |  |
 100 mg/day | 9 (12.3) | 14 (9.7) | 21 (7.6) |  |
Aldosterone antagonist—spironolactone equivalent (N, %) | 76 (100.0) | 153 (100.0) | 300 (99.7) | 0.127§ |
 20–39 mg/day | 2 (2.6) | 2 (1.3) | 0 (0.0) |  |
 40–59 mg/day | 17 (22.4) | 28 (18.3) | 56 (18.7) |  |
 60–79 mg/day | 6 (7.9) | 15 (9.8) | 22 (7.3) |  |
 80–99 mg/day | 11 (14.5) | 28 (18.3) | 54 (18.0) |  |
 100 mg/day | 40 (52.6) | 80 (52.3) | 168 (56.0) |  |