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Table 1 Clinical characteristics and demographic data at baseline (FAS)

From: Tolvaptan therapy of Chinese cirrhotic patients with ascites after insufficient diuretic routine medication responses: a phase III clinical trial

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

    

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)

 
  1. Data are expressed as the mean ± SD or the number of patients (%)
  2. Statistical analyses were conducted using †ANOVA, ‡Fischer’s exact or §Kruskal–Wallis rank sum tests
  3. ALT alanine transaminase, AST aspartate transaminase, BUN blood urea nitrogen, GPT glutamic-pyruvic transaminase, Scr serum creatinine, TB total bilirubin