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1 Hôpital Antoine Béclère, Université Paris-Sud, Clamart, France. 2 Columbia University College of Physicians and Surgeons, New York, NY, 3 Vanderbilt University School of Medicine, Nashville, TN, and 4 Division of Pulmonary and Critical Care Medicine, University of California at San Diego, La Jolla, CA, USA. 5 Università di Bologna, Bologna, Italy. 6 Vrije Universiteit, Amsterdam, the Netherlands
CORRESPONDENCE: M. Humbert, Hôpital Antoine Béclère, Assistance Publique, Hôpitaux de Paris, Université Paris-Sud, 157 rue de la porte de Trivaux, 92140, Clamart, France. Fax: 33 146303824. E-mail: marc.humbert@abc.ap-hop-paris.fr
Keywords: Bosentan, endothelin receptors, epoprostenol, pulmonary arterial hypertension, scleroderma
Received: March 5, 2004
Accepted June 1, 2004
This study was supported by Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.
The efficacy and safety of combining bosentan, an orally active dual endothelin receptor antagonist and epoprostenol, a continuously infused prostaglandin, in the treatment of pulmonary arterial hypertension (PAH) was investigated.
In this double-blind, placebo-controlled prospective study, 33 patients with PAH started epoprostenol treatment (2 ng·kg–1min–1 starting dose, up to 14±2 ng·kg–1min–1 at week 16) and were randomised for 16 weeks in a 2:1 ratio to bosentan (62.5 mg b.i.d for 4 weeks then 125 mg b.i.d) or placebo.
Haemodynamics, exercise capacity and functional class improved in both groups at week 16. In the combination treatment group, there was a trend for a greater (although nonsignificant) improvement in all measured haemodynamic parameters. There were four withdrawals in the bosentan/epoprostenol group (two deaths due to cardiopulmonary failure, one clinical worsening, and one adverse event) and one withdrawal in the placebo/epoprostenol group (adverse event).
This study showed a trend but no statistical significance towards haemodynamics or clinical improvement due to the combination of bosentan and epoprostenol therapy in patients with pulmonary arterial hypertension. Several cases of early and late major complications were reported. Additional information is needed to evaluate the risk/benefit ratio of combined bosentan-epoprostenol therapy in pulmonary arterial hypertension.
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