| |
Treatment Difference (Sildenafil – Placebo) |
| Statistic |
Sildenafil
Low Dose |
Sildenafil Medium Dose |
Sildenafil High Dose |
Sildenafil Combined Dose |
| Mean PAP (mmHg) |
n=39 |
n=55 |
n=71 |
n=165 |
| Mean difference ±SE |
1.6±3.1 |
–3.5±2.7 |
–7.3±2.6 |
–3.1±2.2 |
| 95% CI |
–4.5, 7.6 |
–8.9, 1.9 |
–12.4, –2.1 |
–7.5, 1.3 |
| P value* |
0.610 |
0.199 |
0.006 |
0.172 |
| PVRI (Wood units•m2) |
n=37 |
n=51 |
n=68 |
n=156 |
| Ratio† |
0.982 |
0.819 |
0.727 |
0.836 |
| 95% CI |
0.802, 1.203 |
0.684, 0.981 |
0.612, 0.863 |
0.720, 0.971 |
| P value* |
0.859 |
0.031 |
<0.001 |
0.019 |
| Cardiac index (L/min/m2) |
n=37 |
n=51 |
n=69 |
n=157 |
| Ratio† |
1.100 |
1.043 |
1.148 |
1.096 |
| 95% CI |
0.963, 1.258 |
0.925, 1.176 |
1.026, 1.286 |
0.994, 1.210 |
| P value* |
0.161 |
0.486 |
0.017 |
0.066 |
CI=confidence interval; PVRI=pulmonary vascular resistance index; PAP=pulmonary artery pressure; STARTS-1=Sildenafil in Treatment-Naïve Children, Aged 1 to 17
Years, With Pulmonary Arterial Hypertension.
*With the exception of the primary comparison, P values should be interpreted descriptively because no adjustments were made for multiple comparisons.
†Because PVRI and cardiac index data were log-transformed before analysis, comparisons are presented as ratios (active/placebo) when back-transformed.
N=56, 52 and 55 for the placebo group for mean PAP, PVRI, and cardiac index, respectively. |
