%0 Journal Article %A Vallerie McLaughlin %A Richard N. Channick %A Hossein-Ardeschir Ghofrani %A Jean-Christophe Lemarié %A Robert Naeije %A Milton Packer %A Rogério Souza %A Victor F. Tapson %A Jonathan Tolson %A Hikmet Al Hiti %A Gisela Meyer %A Marius M. Hoeper %T Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension %D 2015 %R 10.1183/13993003.02044-2014 %J European Respiratory Journal %P 405-413 %V 46 %N 2 %X The safety and efficacy of adding bosentan to sildenafil in pulmonary arterial hypertension (PAH) patients was investigated.In this prospective, double-blind, event-driven trial, symptomatic PAH patients receiving stable sildenafil (≥20 mg three times daily) for ≥3 months were randomised (1:1) to placebo or bosentan (125 mg twice daily). The composite primary end-point was the time to the first morbidity/mortality event, defined as all-cause death, hospitalisation for PAH worsening or intravenous prostanoid initiation, atrial septostomy, lung transplant, or PAH worsening. Secondary/exploratory end-points included change in 6-min walk distance and World Health Organization functional class at 16 weeks, change in N-terminal pro-brain natriuretic peptide (NT-proBNP) over time, and all-cause death.Overall, 334 PAH patients were randomised to placebo (n=175) or bosentan (n=159). A primary end-point event occurred in 51.4% of patients randomised to placebo and 42.8% to bosentan (hazard ratio 0.83, 97.31% CI 0.58–1.19; p=0.2508). The mean between-treatment difference in 6-min walk distance at 16 weeks was +21.8 m (95% CI +5.9–37.8 m; p=0.0106). Except for NT-proBNP, no difference was observed for any other end-point. The safety profile of bosentan added to sildenafil was consistent with the known bosentan safety profile.In COMPASS-2, adding bosentan to stable sildenafil therapy was not superior to sildenafil monotherapy in delaying the time to the first morbidity/mortality event.COMPASS-2: adding bosentan was not superior to sildenafil alone in delaying time to first morbidity/mortality event http://ow.ly/NiM65 %U https://erj.ersjournals.com/content/erj/46/2/405.full.pdf