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Longer-term bosentan therapy improves functional capacity in Eisenmenger syndrome: results of the BREATHE-5 open-label extension study

Gatzoulis, Michael A.
Galiè, Nazzareno
Granton, John
Berger, Rolf M F.
Lauer, Andrea
Chiossi, Eleonora
Landzberg, Michael
Published in International journal of cardiology. 2008, vol. 127, no. 1, p. 27-32
Abstract 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.
Keywords AdultAgedAntihypertensive Agents/administration & dosageDouble-Blind MethodDrug Administration ScheduleEisenmenger Complex/drug therapy/physiopathologyExercise ToleranceFemaleHumansMaleMiddle AgedSulfonamides/administration & dosageTreatment OutcomeVascular Resistance/drug effects
PMID: 17658633
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Research groups BREATHE-5 Investigators
L'hypertension pulmonaire (pédiatrie) (228)
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GATZOULIS, Michael A. et al. Longer-term bosentan therapy improves functional capacity in Eisenmenger syndrome: results of the BREATHE-5 open-label extension study. In: International journal of cardiology, 2008, vol. 127, n° 1, p. 27-32. doi: 10.1016/j.ijcard.2007.04.078 https://archive-ouverte.unige.ch/unige:2525

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Deposited on : 2009-08-27

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