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Table 2 Primary and secondary endpoints in participants receiving serelaxin

From: A phase 2 randomised controlled trial of serelaxin to lower portal pressure in cirrhosis (STOPP)

 

Change from baseline to 1 h

Change from baseline to 2 h

HVPG (mmHg)

HVPG (mmHg)

HBF (ml/min)

IVCP (mmHg)

Cardiac index (L/min/m2)

SVRI (dyne·s·cm5·m2)

APWV (m/s)

Mean ± SD pre serelaxin

15.9 ± 3.3

15.9 ± 3.3

1.5 ± 0.8

8.2 ± 3.4

3.8 ± 0.5

1716 ± 398

8.1 ± 1.4

Mean ± SD post serelaxin

15.9 ± 2.1

15.6 ± 4.3

1.2 ± 0.8

9.0 ± 2.4

4.1 ± 0.8

1605 ± 474

8.0 ± 2.1

Arithmetic mean of difference ± SD (95% CI)

−0.4 ± 1.9

(−3.4, 2.6),

p = 0.69

0.4 ± 3.5 (−2.3, 3.1),

p = 0.76

−0.3 ± 0.3

(− 0.7, 0.1),

p = 0.15

0.4 ± 1.7

(1.7, −1.2),

p = 0.58

−0.3 ± 0.7

(− 0.8, 0.3),

p = 0.28

111 ± 394

(− 192, 414),

p = 0.42

0.2 ± 0.7

(− 0.4, 0.8),

p = 0.49

Geometric mean of difference + CV (95% CI)

1.0 + 0.1

(0.8, 1.2),

p = 0.63

1.0 + 0.2

(0.9, 1.2),

p = 0.68

0.8 + 0.2

(0.6, 1.1),

p = 0.15

1.0 + 0.1

(1.0, 1.1),

p = 0.27

1.0 + 0.1

(0.9, 1.1),

p = 0.44

1.0 + 0.0

(1.0, 1.0),

p = 0.32

1.0 + 0.0

(1.0, 1.1),

p = 0.19

  1. Descriptive statistics for the change from baseline in the HVPG and other endpoints, and the results from paired-sample t tests using both the arithmetic mean and the geometric mean
  2. APWV aortic pulse wave velocity, CI confidence interval, CV coefficient of variation, HBF hepatic blood flow, HVPG hepatic venous pressure gradient, IVCP inferior vena cava pressure, SD standard deviation, SVRI systemic venous resistance index