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Pulmonary arterial hypertension: adding Bosentan was not superior to Sildenafil alone in delaying time to first morbidity/mortality event


The safety and efficacy of adding Bosentan ( Tracleer ) to Sildenafil ( Revatio ) in pulmonary arterial hypertension ( PAH ) patients was investigated.

In this prospective, double-blind, event-driven trial, symptomatic PAH patients receiving stable Sildenafil ( greater than or equal to 20 mg three times daily ) for greater than or equal to 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, HR=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. ( Xagena )

McLaughlin V et al, Eur Respir J 2015;46:414-421

XagenaMedicine_2015



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