Source: Annual Congress 2003 - Pulmonary hypertension
Disease area: Pulmonary vascular diseases

Abstract

The endothelin receptor antagonist bosentan is an effective therapy for pulmonary arterial hypertension (PAH). PAH has emerged as a life-threatening complication of HIV infection and patients with HIV-associated PAH (HIV-PAH) could benefit from bosentan therapy.
We report preliminary results for 10 patients from an open-label study of bosentan in HIV-PAH. NYHA functional class III patients received bosentan for 16 weeks (62.5mg bid for 4 weeks; thereafter 125mg bid) with antiretroviral therapy (stable for 3 months). The primary endpoint was change in 6 minute walk distance (6MWD). Borg dyspnea index, NYHA class and hemodynamics were secondary endpoints.
Baseline values for 6MWD, mean pulmonary artery pressure (mPAP), cardiac index (CI) and pulmonary vascular resistance (PVR) were 361±68m, 50.1±10.4mmHg, 2.5±0.6 l/min/m² and 784±277dyn.sec/cm⁵, respectively. By week 16 significant improvements were seen in 6MWD (82±57m; p=0.002), Borg dyspnea index (NS) and NYHA class (9 patients in Class I or II, 1 in Class III). Hemodynamics dramatically improved: mPAP decreased by 8.1±10.2 (p=0.032); CI increased by 0.9±0.6 l/min/m² (p=0.002); PVR decreased by 328±211dyn.sec/cm⁵ (p=0.0008). No relevant changes in liver enzymes or impact of bosentan on virological control of HIV were seen. There was no death or hospitalization for PAH or transition to epoprostenol.
These results suggest that bosentan increases exercise capacity, improves hemodynamics and is well tolerated in NYHA Class III HIV-PAH patients.

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O. Sitbon, V. Gressin, R. Speich, M. Opravil, P. MacDonald, D. Cooper, M. Rainisio, M. Humbert, G. Simonneau (Clamart, France; Zurich, Switzerland; Sydney, Australia). Bosentan in pulmonary arterial hypertension associated with HIV infection. Eur Respir J 2003; 22: Suppl. 45, 3538

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