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Table 2 Secondary and tertiary efficacy endpoints

From: Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial

 

Change from baseline at week 12

Change from baseline at week 64

Change from week 12 to week 64

Endpoint

Placebo (n = 53)

Sildenafil (n = 50)

Placebo (n = 53)

Sildenafil (n = 50)

Placebo (n = 48)

Sildenafil (n = 43)

Borg dyspnoea score (LOCF)

 n

53

49

53

49

47

36

 Median change (range)

0 (−3, 6)

0 (−6, 2)

0 (−3, 7)

0 (−4, 4)

0 (−7, 8)

0 (−2, 4)

WHO functional class (LOCF), n (%)

 Worsened 1 class

1 (2)

0 (0)

4 (8)

5 (10)

4 (8)

8 (19)

 No change

45 (85)

39 (78)

34 (64)

34 (68)

34 (71)

28 (65)

 Improved 1 class

7 (13)

10 (20)

15 (28)

10 (20)

9 (19)

3 (7)

 Died

0

1 (2)

0

1 (2)

0

1 (2)

 Missing

0

0

0

0

1 (2)

3 (7)

BNP

 n

35

33

24

18

21

21

 Median change (min, max), pg/mL

8.0 (−217.5, 254.4)

−1.0 (−436.5, 268.7)

3.0 (−125.4, 738.0)

34.3 (−618.2, 1141.8)

−6.1 (−166.9, 652.0)

20.1 (−643.7, 1218.8)

N-terminal pro-BNP

 n

14

19

9

10

9

12

 Median change (min, max), pg/mL

14.3 (−2227.0, 600.0)

−94.1 (−1277.0, 221.0)

7.8 (−1761.0, 561.3)

−121.7 (−895.3, 5519.4)

55.0 (−1029.0, 466.0)

−13.2 (−459.4, 5656.2)

  1. BNP brain natriuretic peptide, LOCF last observation carried forward, WHO World Health Organization