| Safety and tolerability of bosentan in adults with Eisenmenger physiology. | |
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MedLine Citation:
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PMID: 15676179 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Bosentan, a dual-endothelin receptor antagonist, is an established treatment for pulmonary arterial hypertension. We hypothesized that bosentan is safe and well tolerated in patients with Eisenmenger physiology. METHODS: In this pilot open-label study, we primarily examined safety and tolerability of oral bosentan. Patients were recruited from our adult congenital heart clinic following informed consent. Baseline and 3-month assessment included WHO functional class, resting oxygen saturations, 6-min walk test, transthoracic echocardiography and respiratory mass spectrometry. Patient clinical status and liver enzymes were closely monitored throughout. RESULTS: All 10 study patients (42+/-4 years; eight female) tolerated bosentan well. No major adverse events or significant liver enzyme elevations were observed. All but one patient felt better; none felt worse. Four patients experienced transient leg oedema. Resting oxygen saturations (83+/-5 versus 80+/-5%; P=0.011) and the distance travelled in the 6-min walk test (348+/-112 versus 249+/-117 m; P=0.004) increased relative to baseline. Changes in echocardiographic parameters (maximum aortic forward flow velocity 1.3+/-0.1 versus 1.1+/-0.2 ms, P=0.013; pulmonary arterial acceleration time 66+/-10 versus 58+/-12 m/s, P=0.02) and pulmonary blood flow (3.45+/-1.2 versus 2.58+/-1.0 L/min, P=0.008) suggested improved pulmonary haemodynamics by study end. Other echocardiographic changes suggested improved right ventricular systolic function (septal amplitude 1.0 versus 1.1 cm, P=0.048; systolic tissue Doppler velocity 4.8 versus 2.3 cm s(-1), P=0.002) by study end. CONCLUSIONS: Bosentan was safe and well tolerated in adults with Eisenmenger physiology both at initiation and after 3 months of oral therapy. Clinical status of patients and pulmonary haemodynamics appeared to improve, and this warrants further investigation. |
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Authors:
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Michael A Gatzoulis; Paula Rogers; Wei Li; Carl Harries; Derek Cramer; Simon Ward; Ghada W Mikhail; J Simon R Gibbs |
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Publication Detail:
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Type: Comparative Study; Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: International journal of cardiology Volume: 98 ISSN: 0167-5273 ISO Abbreviation: Int. J. Cardiol. Publication Date: 2005 Jan |
Date Detail:
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Created Date: 2005-01-28 Completed Date: 2006-08-22 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8200291 Medline TA: Int J Cardiol Country: Ireland |
Other Details:
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Languages: eng Pagination: 147-51 Citation Subset: IM |
Affiliation:
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Adult Congenital Heart Program, Royal Brompton Hospital, Sydney Street, London, SW3 6NP, UK. m.gatzoulis@rbh.nthames.nhs.uk |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Antihypertensive Agents / adverse effects, therapeutic use* Blood Flow Velocity / drug effects Blood Pressure / drug effects Eisenmenger Complex / drug therapy*, physiopathology* Exercise Tolerance / drug effects Female Forced Expiratory Volume / drug effects Heart Rate / drug effects Humans London Male Middle Aged Oxygen Consumption / drug effects Pilot Projects Pulmonary Circulation / drug effects Sulfonamides / adverse effects, therapeutic use* Systole / drug effects Treatment Outcome Ventricular Function, Right / drug effects Vital Capacity / drug effects |
| Chemical | |
Reg. No./Substance:
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0/Antihypertensive Agents; 0/Sulfonamides; 147536-97-8/bosentan |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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