Table 2.
Change in Prespecified Outcomes at 16 Weeks
| Bosentan (n = 25) | Placebo (n = 14) | P Value | |
|---|---|---|---|
| ∆ PVR index | −1.1 (3.9) | 0.8 (4.2) | 0.19 |
| ∆ mPAP, mm Hg | −1.3 (5.6) | 0.2 (7.4) | 0.43 |
| ∆ mRAP, mm Hg | −1.7 (5.5) | −0.8 (5.2) | 0.74 |
| ∆ Cardiac index, L/min/m2 | 0.1 (0.5) | −0.1 (0.4) | 0.31 |
| ∆ SpO2, % | −0.76 (4.0) | −0.57 (3.9) | 0.74 |
| ∆ 6MWD, m | −25.9 (56.7) | −53.1 (66.9) | 0.42 |
| ∆ 6MWT, dyspnea pre | 0.8 (1.4) | 1.1 (2.0) | 0.98 |
| ∆ 6MWT, dyspnea post | −0.04 (2.3) | 0.0 (1.2) | 0.51 |
| ∆ 6MWT, fatigue pre | 0.4 (2.9) | 0.4 (1.7) | 0.71 |
| ∆ 6MWT, fatigue post | 0.2 (3.7) | −1.8 (1.8) | 0.12 |
| ∆ CAMPHOR, symptom score | 0.0 (4.5) | 0.4 (3.5) | 0.92 |
| ∆ CAMPHOR, activities score | 1.2 (3.8) | 0.9 (4.5) | 0.94 |
| ∆ CAMPHOR, QOL score | 0.2 (4.3) | 0.3 (3.8) | 0.96 |
| ∆ DlCO, % predicted | −3.2 (6.9) | −2.1 (4.9) | 0.96 |
| ∆ Kco, % predicted | −5.8 (8.9) | −0.2 (14.5) | 0.54 |
| ∆ FVC, % predicted | −0.9 (6.8) | −2.6 (23.2) | 0.96 |
| ∆ CPI | 2.0 (5.2) | 0.4 (6.0) | 0.95 |
| ∆ BNP, pg/ml | 13.0 (90.5) | 21.0 (50.4) | 0.32 |
| ∆ TAPSE, mm | 1.8 (4.4) | 1.4 (4.7) | 0.56 |
| ∆ RV inlet size, mm | 0.4 (0.8) | −0.1 (0.6) | 0.12 |
Definition of abbreviations: 6MWD = 6-minute-walk distance; 6MWT = 6-minute-walk test; BNP = brain natriuretic peptide; CAMPHOR = Cambridge Pulmonary Hypertension Outcome Review; CPI = composite physiologic index; DlCO = diffusing capacity of carbon monoxide; Kco = transfer factor; mPAP = mean pulmonary artery pressure; mRAP = mean right atrial pressure; PVR = pulmonary vascular resistance; QOL = quality of life; RV = right ventricle; Spo2 = oxygen saturation; TAPSE = tricuspid annular plane systolic excursion.
All values are presented as mean (standard deviation).