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Table 7 Comparison of changes in serum creatinine, BUN, TB, AST and ALT on day 4 and day 7 among the 3 groups (SS)

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

 

Placebo (mg/day) (N = 76)

Tolvaptan

P value

7.5 mg/day (N = 153)

15 mg/day (N = 304)

Mean ± SD

Changes from baseline

Mean ± SD

Changes from baseline

Mean ± SD

Changes from baseline

7.5 mg/day tolvaptan versus placebo

15 mg/day mg tolvaptan versus placebo

7.5 mg/day versus 15.0 mg/day tolvaptan

Serum creatinine (mg/dL)

Baseline

0.8 ± 0.2

–

0.8 ± 0.3

–

0.9 ± 0.3

–

–

–

–

Day 4

0.8 ± 0.2

0.0 ± 0.1

0.9 ± 0.3

0.1 ± 0.2

0.9 ± 0.3

0.1 ± 0.2

0.030

0.001

0.173

Day 7

0.8 ± 0.2

0.0 ± 0.2

0.9 ± 0.3

0.1 ± 0.2

0.9 ± 0.3

0.1 ± 0.2

0.119

0.019

0.517

BUN (mmol/L)

Baseline

6.2 ± 3.0

–

6.3 ± 3.4

–

6.8 ± 3.6

–

–

–

–

Day 4

5.8 ± 2.7

− 0.1 ± 1.0

6.2 ± 3.4

0.1 ± 1.6

6.5 ± 3.6

− 0.1 ± 1.7

0.428

0.871

0.434

Day 7

6.7 ± 3.4

0.5 ± 2.5

6.8 ± 4.0

0.5 ± 2.5

6.7 ± 3.9

0.0 ± 2.0

0.987

0.086

0.027

TB (µmol/L)

Baseline

43.8 ± 42.1

–

49.2 ± 57.2

–

43.6 ± 47.7

–

–

–

–

Day 4

40.7 ± 37.4

0.6 ± 11.1

45.6 ± 45.0

1.1 ± 13.6

46.4 ± 57.5

2.8 ± 21.0

0.809

0.252

0.317

Day 7

44.8 ± 52.8

2.6 ± 21.7

48.2 ± 50.4

3.4 ± 23.7

44.6 ± 58.0

0.8 ± 20.2

0.822

0.526

0.260

AST (IU/L)

Baseline

67.4 ± 54.9

–

68.8 ± 56.9

–

66.0 ± 54.2

–

–

–

–

Day 4

68.6 ± 61.0

3.0 ± 15.2

65.7 ± 55.3

0.2 ± 20.8

65.0 ± 57.9

− 0.6 ± 22.7

0.280

0.133

0.741

Day 7

68.1 ± 66.2

2.0 ± 18.6

71.0 ± 64.5

4.0 ± 32.7

69.5 ± 66.1

2.2 ± 36.7

0.573

0.951

0.614

ALT/GPT (IU/L)

Baseline

42.2 ± 27.1

–

43.1 ± 37.7

–

44.2 ± 39.3

–

–

–

–

Day 4

40.5 ± 26.8

− 1.1 ± 8.8

42.0 ± 36.9

0.6 ± 12.8

44.0 ± 35.0

− 0.5 ± 18.5

0.274

0.712

0.467

Day 7

39.3 ± 26.9

− 1.8 ± 11.6

44.3 ± 40.0

1.9 ± 19.8

45.5 ± 39.5

0.4 ± 30.3

0.087

0.335

0.529

  1. ALT alanine transaminase, AST aspartate transaminase, BUN blood urea nitrogen, GPT glutamic-pyruvic transaminase, Scr serum creatinine, TB total bilirubin
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BMC Gastroenterology

ISSN: 1471-230X

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