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Published ahead of print on August 18, 2004, doi:10.1164/rccm.200404-445OC

Am. J. Respir. Crit. Care Med., Volume 170, Number 11, December 2004, 1212-1217

A more recent version of this article appeared on December 1, 2004
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Submitted on April 2, 2004
Accepted on August 16, 2004

Bosentan for Human Immunodeficiency Virus-associated Pulmonary Arterial Hypertension

Olivier Sitbon1*, Virginie Gressin2, Rudolf Speich3, Peter S Macdonald4, Milos Opravil3, David A Cooper4, Thierry Fourme1, Marc Humbert1, Jean-Francois Delfraissy5, and Gerald Simonneau1

1 Service de Pneumologie et Reanimation, Hopital Antoine Beclere, Clamart, France, 2 Actelion Pharmaceutical Ltd., Paris, France, 3 University Hospital, Zurich, Switzerland, 4 St. Vincent's Hospital, Sydney, Australia, 5 Hopital de Bicetre, Le Kremlin-Bicetre, France

* To whom correspondence should be addressed. E-mail: olivier.sitbon{at}abc.ap-hop-paris.fr.

Clinical studies have shown the importance of endothelin as a pathogenic mediator in pulmonary arterial hypertension (PAH). We describe the effects of bosentan, an oral dual endothelin receptor antagonist, in patients with PAH associated with human immunodeficiency virus (HIV) infection. In this prospective study, 16 patients with PAH associated with HIV infection in stable condition received bosentan for 16 weeks. Efficacy endpoints included exercise capacity, cardiopulmonary hemodynamics, Doppler-echocardiography, NYHA functional class, and quality of life (SF-36 and EQ-5D). Safety was assessed by laboratory tests, vital signs, ECG and adverse events. Improvements were observed from baseline to Week 16 in all efficacy parameters: 6-minute walk distance (+91 ± 60 m, p < 0.001), NYHA class (14 patients improved), hemodynamics (cardiac index: +0.9 ± 0.7 l/min/m2, p < 0.001), Doppler-echocardiographic variables and quality of life. During the study, no patient died and none required epoprostenol treatment. Hepatic tolerability was similar to that reported in PAH patients. Bosentan had no negative impact on control of HIV infection. Although limited by uncontrolled design, small sample size and short duration, this study suggests that bosentan may benefit patients with PAH associated with HIV infection and that endothelin is an important pathogenic mediator in this disease.
Key words: Endothelin, bosentan, pulmonary arterial hypertension, HIV infection, Doppler echocardiography




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