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Randomized study of adding inhaled iloprost to existing bosentan in pulmonary arterial hypertension.
- Source :
-
American journal of respiratory and critical care medicine [Am J Respir Crit Care Med] 2006 Dec 01; Vol. 174 (11), pp. 1257-63. Date of Electronic Publication: 2006 Aug 31. - Publication Year :
- 2006
-
Abstract
- Rationale: Small, open-label studies suggest that combinations of existing therapies may be effective for pulmonary arterial hypertension (PAH).<br />Objective: To evaluate the safety and efficacy of adding inhaled iloprost, a prostacyclin analog, to the endothelin receptor antagonist bosentan in patients with PAH.<br />Methods: In a randomized, multicenter, double-blind trial, inhaled iloprost (5 mug) or placebo was added to stable monotherapy with bosentan for 12 wk. Efficacy endpoints included change from baseline in 6-min-walk distance (6-MWD), modified New York Heart Association (NYHA) functional class, hemodynamic parameters, and time to clinical worsening.<br />Measurements and Main Results: A total of 67 patients with PAH (55% idiopathic PAH, 45% associated PAH, 94% NYHA class III, and mean baseline 6-MWD of 335 m) were randomized. At Week 12, patients receiving iloprost had a mean increase in 6-MWD of 30 m (p = 0.001); placebo patients had a mean 6-MWD increase of 4 m (p = 0.69), with a placebo-adjusted difference of +26 m (p = 0.051). NYHA status improved by one class in 34% of iloprost versus 6% of placebo patients (p = 0.002). Iloprost delayed the time to clinical worsening (p = 0.0219). Improvements were noted in postinhalation placebo-adjusted change in mean pulmonary artery pressure (-8 mm Hg; p < 0.001) and pulmonary vascular resistance (-254 dyn x s x cm(-5); p < 0.001). Combination therapy was well tolerated.<br />Conclusions: Within the limitations of a relatively small sample size, results of this study demonstrate that the addition of inhaled iloprost in patients with PAH with reduced exercise capacity on bosentan monotherapy is safe and efficacious.
- Subjects :
- Adolescent
Adult
Aged
Bosentan
Double-Blind Method
Drug Therapy, Combination
Female
Humans
Hypertension, Pulmonary physiopathology
Male
Middle Aged
Antihypertensive Agents therapeutic use
Hypertension, Pulmonary drug therapy
Iloprost therapeutic use
Sulfonamides therapeutic use
Vasodilator Agents therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1073-449X
- Volume :
- 174
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- American journal of respiratory and critical care medicine
- Publication Type :
- Academic Journal
- Accession number :
- 16946127
- Full Text :
- https://doi.org/10.1164/rccm.200603-358OC