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Table 3 Treatment comparisons to placebo for PVRI, mPAP, and CI in the Down syndrome and non–Down syndrome populations

From: Efficacy and safety of oral sildenafil in children with Down syndrome and pulmonary hypertension

  

Comparison to Placebo (95% CI)

   

All Non–Down Syndrome

Non–Down Syndrome

Parameter

Treatment Group

Down Syndrome

 

Developmentally Able

IPAH/HPAH

PVRI, ratio active/placebo

Low Dose

1.02 (0.62, 1.69)

(n = 6)

0.99 (0.80, 1.24) (n = 31)

0.96 (0.74, 1.24)

(n = 24)

0.96 (0.67, 1.38)

(n = 11)

Medium Dose

0.81 (0.54, 1.22)

(n = 10)

0.82 (0.67, 1.00) (n = 41)

0.78 (0.61, 1.00)

(n = 27)

0.75 (0.54, 1.03)

(n = 17)

High Dose

1.11 (0.76, 1.62)

(n = 14)

0.64 (0.53, 0.78) (n = 54)

0.56 (0.43, 0.72)

(n = 26)

0.67 (0.50, 0.90)

(n = 23)

Combined Dose

0.97 (0.68, 1.38) (n = 30)

0.81 (0.68, 0.95) (n = 126)

0.74 (0.60, 0.91) (n = 75)

0.78 (0.60, 1.02)

(n = 51)

mPAP, difference from placebo, mmHg

Low Dose

12.3 (−2.0, 26.5)

(n = 6)

−0.99 (−7.55, 5.56)

(n = 33)

−2.4 (−10.1, 5.3) (n = 26)

−1.0 (−11.0, 8.9)

(n = 12)

Medium Dose

−2.8 (−14.4, 8.7)

(n = 12)

−4.15 (−10.15, 1.85) (n = 43)

−7.7 (−15.3, −0.2)

(n = 28)

−2.8 (−11.7, 6.1)

(n = 18)

High Dose

2.8 (−8.4,13.9)

(n = 14)

−10.52 (−16.25, −4.79) (n = 57)

−17.2 (−24.9, −9.6)

(n = 27)

−7.7 (−16.0, 0.7)

(n = 24)

Combined Dose

4.1 (−5.8, 13.9)

(n = 32)

−5.22 (−10.12, −0.32) (n = 133)

−9.6 (−15.7, −3.5)

(n = 79)

−3.8 (−11.2, 3.5)

(n = 54)

CI, ratio active/placebo

Low Dose

1.02 (0.62, 1.67)

(n = 6)

1.08 (0.94, 1.23) (n = 31)

1.10 (0.94, 1.27)

(n = 24)

1.07 (0.87, 1.31)

(n = 12)

Medium Dose

0.84 (0.57, 1.24)

(n = 10)

1.09 (0.96, 1.23) (n = 41)

1.09 (0.95, 1.27)

(n = 27)

1.24 (1.02, 1.50)

(n = 17)

High Dose

1.07 (0.74, 1.55)

(n = 14)

1.16 (1.04, 1.30) (n = 55)

1.25 (1.08, 1.45)

(n = 27)

1.35 (1.13, 1.62)

(n = 23)

Combined Dose

0.97 (0.69, 1.38)

(n = 30)

1.11 (1.01, 1.22) (n = 127)

1.14 (1.01, 1.29) (n = 76)

1.21 (1.03, 1.43)

(n = 52)

  1. CI cardiac index, HPAH heritable pulmonary arterial hypertension, IPAH idiopathic pulmonary arterial hypertension, mPAP mean pulmonary artery pressure, PVRI pulmonary vascular resistance index