0
Abstract: Slide Presentations |

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ILOPROST INHALATION AS ADD-ON THERAPY TO BOSENTAN IN PULMONARY ARTERIAL HYPERTENSION (PAH) FREE TO VIEW

Vallerie V. McLaughlin, MD*; Ronald Oudiz, MD; Adaani Frost, MD; Victor Tapson, MD; Srinivas Murali, MD; Richard Channick, MD; David Badesch, MD; Robyn Barst, MD; Henry Hsu, MD; Lewis Rubin, MD
Author and Funding Information

University of Michigan, Ann Arbor, MI


Chest


Chest. 2005;128(4_MeetingAbstracts):160S. doi:10.1378/chest.128.4_MeetingAbstracts.160S
Text Size: A A A
Published online

Abstract

PURPOSE:  Inhaled iloprost, a prostacyclin analogue, is safe and effective monotherapy for PAH. Combination therapy may enhance treatment options for PAH. We assessed the safety and efficacy of adding inhaled iloprost to bosentan in PAH.

METHODS:  In this prospective multicenter study, PAH patients on a stable dose of bosentan were randomized to inhaled iloprost 5 mcg or placebo 6 times daily up to 9/day for 12 weeks. Patients were evaluated for safety and the following efficacy measures: change in 6-minute walk distance (6-MWD), Borg Dyspnea Score, NYHA Class, time-to-clinical-worsening, and hemodynamics.

RESULTS:  Fifteen U.S. centers enrolled 67 PAH patients (55% idiopathic PAH, 45% associated PAH). The mean age was 50 years and 79% were female. Most patients were in NYHA class III (94%) with a mean baseline 6-MWD of 338 m. Inhalation dosing compliance was 94% in both groups, with most taking 6 inhalations/day and 125 mg BID bosentan. At Week 12, patients receiving iloprost had a mean increase of 30 m in their 6-MWD compared to baseline (p = 0.0013), while those on placebo had a mean increase of 4 m (p = 0.69), with a placebo-adjusted difference of +26 m (p = 0.0513). This was accompanied by a reduction in Borg Dyspnea Score in the iloprost group (P=0.03 vs baseline). NYHA class improved by one Class in 34% iloprost patients compared with 6% placebo (p = 0.0023). Iloprost delayed time-to-clinical-worsening (p = 0.0219) with 0/32 iloprost patients and 5/33 (15%) placebo patients experiencing clinical deterioration. Improvements were noted in placebo adjusted change in mPAP, 8 mmHg (p <0.0001), and PVR, 244 dynes•sec•cm-5 (p = 0.0007). Adverse events with combination therapy were consistent with the known safety profile of inhaled iloprost and included cough, headache, jaw pain, and flushing. Syncope was infrequent overall (1 iloprost, 2 placebo).

CONCLUSION:  Combination therapy with inhaled iloprost and bosentan was safe and provided additional efficacy compared with bosentan alone.

CLINICAL IMPLICATIONS:  Inhaled iloprost may be a useful adjunct therapy to bosentan in PAH patients.

DISCLOSURE:  Vallerie McLaughlin, Grant monies (from industry related sources); Consultant fee, speaker bureau, advisory committee, etc.

Monday, October 31, 2005

2:30 PM - 4:00 PM


Figures

Tables

References

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543