Change from baseline to end of week 12 in primary and secondary variables in the subgroup of patients with PAH-CHD in Pulmonary Arterial hyperTENsion sGC-stimulator Trial-1 (observed values)
| Placebo | Riociguat 2.5 mg–maximum | Riociguat 1.5 mg–maximum | |||||||
|---|---|---|---|---|---|---|---|---|---|
| n | Baseline | Change from baseline | n | Baseline | Change from baseline | n | Baseline | Change from baseline | |
| 6MWD (m) | 12 | 360±59 | 0±42 | 15 | 369±78 | +39±60* | 8 | 391±59 | +43±54† |
| PVR (dyn·s/cm5) | 11 | 1312±763 | −66±632 | 13 | 1130±664 | −250±410 | 7 | 1047±564 | −126±368 |
| NT-proBNP (pg/mL) | 12 | 1573±1775 | −46±697 | 13 | 761±1172 | −164±317† | 7 | 1352±1350 | −872±1147† |
| WHO FC (%) | 12 | II–58% III–42% | Improved 8% Stabilised 83% Worsened 8% | 15 | II–67% III–33% | Improved 21% Stabilised 79% Worsened 0%† | 8 | II–50% III–50% | Improved 29% Stabilised 71% Worsened 0%† |
| Borg dyspnoea score | 12 | 4.3±2.7 | −0.1±2.4 | 15 | 2.5±1.4 | −0.3±1.3* | 8 | 3.2±1.6 | −0.8±0.8† |
| EQ-5D score | 12 | 0.74±0.16 | −0.05±0.22 | 15 | 0.78±0.15 | +0.03±0.18† | 8 | 0.74±0.08 | +0.09±0.14† |
| LPH score | 12 | 40.4±20.0 | −0.1±15.8 | 15 | 34.9±26.0 | −8.0±15.9† | 8 | 40.0±15.3 | −13.7±13.2† |
Data are mean±SD unless otherwise indicated.
*Data missing for two patients.
†Data missing for one patient.
6MWD, 6-min walking distance; CHD, congenital heart disease; EQ-5D, EuroQol Group 5-Dimensional Self-report Questionnaire (scores range from −0.6 to 1.0, with higher scores indicating a better quality of life); LPH, Living with Pulmonary Hypertension questionnaire (an adaptation of the Minnesota Living with Heart Failure Questionnaire; scores range from 0 to 105, with higher scores indicating worse quality of life); NT-proBNP, N-terminal of the prohormone of brain natriuretic peptide; PAH, pulmonary arterial hypertension; PVR, pulmonary vascular resistance; WHO FC, WHO functional class.