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

Autor: Michael A, Gatzoulis, Maurice, Beghetti, Nazzareno, Galiè, John, Granton, Rolf M F, Berger, Andrea, Lauer, Eleonora, Chiossi, Michael, Landzberg, Dorothy D, Pearson
Přispěvatelé: Faculteit Medische Wetenschappen/UMCG, Cardiovascular Centre (CVC), Vascular Ageing Programme (VAP), Gatzoulis MA., Beghetti M., Galiè N., Granton J., Berger RM., Lauer A., Chiossi E., Landzberg M.
Rok vydání: 2008
Předmět:
Male
Eisenmenger Complex/drug therapy/physiopathology
Placebo-controlled study
Hemodynamics
PLACEBO-CONTROLLED TRIAL
PULMONARY-ARTERIAL-HYPERTENSION
law.invention
DOUBLE-BLIND
Randomized controlled trial
law
pulmonary arterial hypertension
Sulfonamides
ddc:618
Exercise Tolerance
DEATH
Middle Aged
Treatment Outcome
Anesthesia
SURVIVAL
Arterial blood
Female
Cardiology and Cardiovascular Medicine
PROSTACYCLIN ANALOG
medicine.drug
Adult
RECEPTOR ANTAGONIST BOSENTAN
endothelin receptor antagonism
Drug Administration Schedule
Double-Blind Method
medicine
Humans
PHYSIOLOGY
Antihypertensive Agents
Aged
Sulfonamides/administration & dosage
Vascular disease
business.industry
Vascular Resistance/drug effects
Eisenmenger syndrome
Bosentan
ADULTS
Eisenmenger Complex
medicine.disease
Pulmonary hypertension
respiratory tract diseases
Vascular Resistance
Antihypertensive Agents/administration & dosage
business
Zdroj: International Journal of Cardiology, 127(1), 27-32. ELSEVIER IRELAND LTD
International journal of cardiology, Vol. 127, No 1 (2008) pp. 27-32
ISSN: 0167-5273
1874-1754
DOI: 10.1016/j.ijcard.2007.04.078
Popis: 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.
Databáze: OpenAIRE
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