| Longer-term bosentan therapy improves functional capacity in Eisenmenger syndrome: results of the BREATHE-5 open-label extension study. | |
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MedLine Citation:
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PMID: 17658633 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Bosentan, an oral endothelin ET(A)/ET(B) receptor antagonist, improves hemodynamics and exercise capacity in patients with Eisenmenger syndrome but longer-term effects are unknown. This study investigated the efficacy and safety of bosentan up to 40 weeks in these patients. METHODS: Following the 16-week, double blind, placebo-controlled BREATHE-5 study of bosentan in patients with Eisenmenger syndrome, an open-label extension (OLE) was performed. Patients who completed BREATHE-5 received bosentan for an additional 24 weeks (62.5 mg b.i.d. for 4 weeks, then 125 mg b.i.d.) and were analyzed in two groups; ex-placebo and ex-bosentan, according to BREATHE-5 treatment. RESULTS: Thirty-seven patients with Eisenmenger syndrome who participated in BREATHE-5 were included in the OLE. At week 24, the 6-minute walk distance (mean+/-SE) increased from OLE baseline for the ex-placebo (+33.2+/-23.9 m) and ex-bosentan group (+6.7+/-10.0 m). The overall improvement from baseline of BREATHE-5 was +61.3+/-8.1 m (95% confidence interval: [44.7, 78.0]) for the ex-bosentan group. WHO functional class was improved in both groups. Bosentan did not reduce systemic arterial blood oxygen saturation; safety profile was comparable to previous trials. CONCLUSIONS: In conclusion, these longer follow-up data support the efficacy and safety profile reported in the preceding BREATHE-5 study of bosentan treatment of Eisenmenger syndrome, challenging the notion that pulmonary vascular disease and severe functional impairment in these patients are not amenable to therapy. |
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Authors:
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Michael A Gatzoulis; Maurice Beghetti; Nazzareno Galiè; John Granton; Rolf M F Berger; Andrea Lauer; Eleonora Chiossi; Michael Landzberg; |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2007-07-20 |
Journal Detail:
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Title: International journal of cardiology Volume: 127 ISSN: 1874-1754 ISO Abbreviation: Int. J. Cardiol. Publication Date: 2008 Jun |
Date Detail:
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Created Date: 2008-05-27 Completed Date: 2008-07-31 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8200291 Medline TA: Int J Cardiol Country: Netherlands |
Other Details:
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Languages: eng Pagination: 27-32 Citation Subset: IM |
Affiliation:
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Royal Brompton Hospital and the National Heart and Lung Institute, Imperial College, London, UK. m.gatzoulis@rbh.nthames.nhs.uk |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Antihypertensive Agents / administration & dosage* Double-Blind Method Drug Administration Schedule Eisenmenger Complex / drug therapy*, physiopathology* Exercise Tolerance* Female Humans Male Middle Aged Sulfonamides / administration & dosage* Treatment Outcome Vascular Resistance / drug effects |
| Chemical | |
Reg. No./Substance:
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0/Antihypertensive Agents; 0/Sulfonamides; 147536-97-8/bosentan |
| Investigator | |
Investigator/Affiliation:
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John Hess / ; Alessandra Manes / ; Mario Vigano / ; Elke S Hoendermis / ; José Maria Oliver / ; W Stewart Hillis / ; Carl Harries / ; Dorothy D Pearson / |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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