Document Detail

The safety and effects of bosentan in patients with a Fontan circulation.
MedLine Citation:
PMID:  22348734     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE:   Adult patients with a Fontan circulation tend to have diminished exercise capacity. The principal objective of this study was to investigate the safety of the endothelin receptor antagonist bosentan in Fontan patients, and, secondarily, to assess effects on cardiovascular performance, New York Heart Association functional classification (NYHA FC), and ventricular function.
DESIGN:   A 6-month prospective, single-center, pilot, safety study of bosentan in Fontan patients. Setting.  Adult Congenital Heart Disease referral center.
PATIENTS:   All patients ≥18 years old with a Fontan circulation and in NYHA FC ≥II were invited to enroll. Interventions.  Patients started on 62.5 mg bid of bosentan, uptitrating to 125 mg bid after 2 weeks.
OUTCOME MEASURES:   Safety was assessed by the incidence of anticipated and unanticipated adverse events during the 6-month study period; specifically those relating to hepatic, renal, or hematological dysfunction as measured by monthly blood tests. Other outcome measures included cardiopulmonary exercise test, 6-minute walk distance test, Borg dyspnea index, NYHA FC, and ventricular function parameters using transthoracic echocardiography.
RESULTS:   Of the eight patients enrolled, six completed the study. Two patients withdrew from the study (one for non-trial related reasons, one due to adverse events). No clinically significant adverse events relating to bosentan therapy occurred during this study and, in particular, no significant abnormalities in hepatic function tests were observed. Three patients reported transient adverse events. Improvements in NYHA FC and systolic ventricular function were observed after 6 months of bosentan treatment.
CONCLUSIONS:   The small number of patients with a Fontan circulation in our study was able to tolerate bosentan for 6 months. The safety and tolerability of bosentan in a larger patient population remains unknown. The results presented here justify further investigation in larger studies.
Sarah E Bowater; Rebekah A Weaver; Sara A Thorne; Paul F Clift
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Publication Detail:
Type:  Clinical Trial; Journal Article     Date:  2012-02-20
Journal Detail:
Title:  Congenital heart disease     Volume:  7     ISSN:  1747-0803     ISO Abbreviation:  Congenit Heart Dis     Publication Date:    2012 May-Jun
Date Detail:
Created Date:  2012-05-28     Completed Date:  2012-09-24     Revised Date:  2013-06-18    
Medline Journal Info:
Nlm Unique ID:  101256510     Medline TA:  Congenit Heart Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  243-9     Citation Subset:  IM    
Copyright Information:
© 2012 Wiley Periodicals, Inc.
University Hospital Birmingham Foundation NHS Trust, Birmingham, United Kingdom.
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MeSH Terms
Cardiovascular Agents / adverse effects,  therapeutic use*
Echocardiography, Doppler
Exercise Test
Exercise Tolerance / drug effects
Fontan Procedure / adverse effects*
Heart Defects, Congenital / surgery*
Pilot Projects
Postoperative Complications / drug therapy*,  etiology,  metabolism,  physiopathology,  ultrasonography
Predictive Value of Tests
Prospective Studies
Pulmonary Artery / drug effects*,  metabolism,  physiopathology
Receptors, Endothelin / antagonists & inhibitors,  metabolism
Recovery of Function
Sulfonamides / adverse effects,  therapeutic use*
Time Factors
Treatment Outcome
Vascular Resistance / drug effects
Ventricular Function / drug effects
Reg. No./Substance:
0/Cardiovascular Agents; 0/Receptors, Endothelin; 0/Sulfonamides; Q326023R30/bosentan

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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