TABLE 2

Primary end-point events in the placebo and bosentan groups

PlaceboBosentan
Patients n175159
Primary end-point event90 (51.4)68 (42.8)
Worsening of PAH#52 (29.7)32 (20.1)
Hospitalisation for PAH or start of i.v. prostanoid therapy20 (11.4)25 (15.7)
Death18 (10.3)10 (6.3)
Atrial septostomy0 (0.0)1 (0.6)
Lung transplantation0 (0.0)0 (0.0)
  • Data are presented as n (%) unless otherwise stated. Events listed are the first confirmed morbidity/mortality events. PAH: pulmonary arterial hypertension. #: worsening PAH was 1) “moderately worse” or “markedly worse” symptoms and requirement for addition of PAH therapy (initiation of a subcutaneous or inhaled prostanoid, or transfer to open-label bosentan), or 2) “no change” or “mildly worse” symptoms, and requirement for addition of PAH therapy and deterioration in 6-min walk distance >20% from the previous visit or >30% from the baseline visit.