TABLE 1.
End-point | Placebo | Riociguat | p-value# | ||||
Patients | Baseline | Change | Patients | Baseline | Change | ||
Primary end-point | |||||||
6MWD m | 88 | 356±75 | –6±84 | 173 | 342±82 | 39±79 | <0.001 |
Selected secondary end-points | |||||||
PVR dyn·s·cm–5 | 82 | 779±401 | 23±274 | 151 | 791±432 | –226±248 | <0.001 |
NT-proBNP pg·mL−1 | 73 | 1706±2567 | 76±1447 | 150 | 1508±2338 | –291±1717 | <0.001 |
WHO-FC | 87 | Class I: 0 Class II: 25 (29%) Class III: 60 (69%) Class IV: 2 (2%) | 13 (15%) moved to lower class; 68 (78%) stayed the same; 6 (7%) moved to higher class | 173 | Class I: 3 (2%) Class II: 55 (32%) Class III: 107 (62%) Class IV: 8 (5%) | 57 (33%) moved to lower class; 107 (62%) stayed the same; 9 (5%) moved to higher class | 0.003 |
Data are presented as n or mean±sd, 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. #: calculated with the use of stratified Wilcoxon test for the change from baseline to last visit. Reproduced and modified from [26] with permission from the publisher.