Format

Send to

Choose Destination
See comment in PubMed Commons below
Am J Respir Crit Care Med. 2006 Dec 1;174(11):1257-63. Epub 2006 Aug 31.

Randomized study of adding inhaled iloprost to existing bosentan in pulmonary arterial hypertension.

Author information

1
The University of Michigan Health System, Ann Arbor, Michigan, USA. vmclaugh@umich.edu

Abstract

RATIONALE:

Small, open-label studies suggest that combinations of existing therapies may be effective for pulmonary arterial hypertension (PAH).

OBJECTIVE:

To evaluate the safety and efficacy of adding inhaled iloprost, a prostacyclin analog, to the endothelin receptor antagonist bosentan in patients with PAH.

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.

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.

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.

PMID:
16946127
DOI:
10.1164/rccm.200603-358OC
[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Atypon
    Loading ...
    Support Center