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Table 4 The improvement of ascites and lower extremity edema (LOCF)

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

 

Placebo (mg) (N = 76)

Tolvaptan

P value

 

7.5 mg/day (N = 153)

15 mg/day (N = 301)

 

Improvement

No changes

Degradation

Improvement

No changes

Degradation

Improvement

No changes

Degradation

7.5 mg Tolvaptan versus placebo

15.0 mg Tolvaptan versus placebo

7.5 mg versus 15.0 mg Tolvaptan

Improvement rate of ascites (N, %)

         

 Day 4

28 (36.8)

38 (50.0)

10 (13.2)

70 (45.8)

71 (46.4)

12 (7.8)

152 (50.5)

125 (41.5)

24 (8.0)

0.130

0.023

0.403

 Day 7

31 (40.8)

34 (44.7)

11 (14.5)

82 (53.6)

60 (39.2)

11 (7.2)

180 (59.8)

93 (30.9)

28 (9.3)

0.037

0.003

0.342

Improvement rate of lower extremity edema (N, %)

         

 Day 4

12 (46.2)

12 (46.2)

2 (7.7)

23 (51.1)

21 (46.7)

1 (2.2)

48 (55.2)

39 (44.8)

0 (0.0)

0.395

0.223

0.766

 Day 7

14 (53.8)

10 (38.5)

2 (7.7)

33 (71.7)

12 (26.1)

1 (2.2)

60 (67.4)

27 (30.3)

2 (2.2)

0.077

0.088

0.773