TABLE 2.
Change from baseline in primary and selected secondary end-points with bosentan and placebo in the Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension (BENEFiT) study
| End-point | Placebo | Bosentan | p-value# | ||||
| Patients | Baseline | Change | Patients | Baseline | Change | ||
| Co-primary end-points | |||||||
| 6MWD m | 73 | 344.5 (325.2–363.8) | 0.8 (–18.1–19.7) | 67 | 340.0 (319.2–360.8) | 2.9 (–12.9–18.8) | 0.5449 |
| PVR dyn·s·cm–5 | 71 | 787 (708–866) | 30 (–25–85) | 66 | 778 (698–857) | –146 (–207– –85) | <0.0001 |
| Selected secondary end-points | |||||||
| NT-proBNP ng·L−1 | 76 | 1405 | 72 | 1481 | –622 (–1018– –225)¶ | 0.0034 | |
| WHO-FC II/III/IV | 80 | 22/56/2 | 11.3% moved to lower class; 8.8% moved to higher class | 76 | 22/51/3 | 14.5% moved to lower class; 2.6% moved to higher class | ns |
Data are presented as n or mean (95% confidence interval), unless otherwise stated. 6MWD: 6-min walking distance; PVR: pulmonary vascular resistance; NT-proBNP: N-terminal pro-brain natriuretic peptide; WHO-FC: World Health Organization functional class; ns: nonsignificant. #: calculated with the use of stratified Wilcoxon test for the change from baseline and the Wilcoxon rank sum test for treatment effect; ¶: data for treatment effect, not change from baseline. Data from [41].