Journal article

Publication year: 2015

Pages: 405-413

Journal: European Respiratory Journal

Volume number: 46

Issue number: 2

ISSN: 0903-1936

eISSN: 1399-3003

Open access status: Bronze

DOI Link: https://doi.org/10.1183/13993003.02044-2014

Publisher: European Respiratory Society

Abstract: 

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.

Harvard Citation style: McLaughlin, V., Channick, R., Ghofrani, H., Lemarie, J., Naeije, R., Packer, M., et al. (2015) Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension, European Respiratory Journal, 46(2), pp. 405-413. https://doi.org/10.1183/13993003.02044-2014

APA Citation style: McLaughlin, V., Channick, R., Ghofrani, H., Lemarie, J., Naeije, R., Packer, M., Souza, R., Tapson, V., Tolson, J., Al Hiti, H., Meyer, G., & Hoeper, M. (2015). Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension. European Respiratory Journal. 46(2), 405-413. https://doi.org/10.1183/13993003.02044-2014