Long-term bosentan treatment of complex congenital heart disease and Eisenmenger's syndrome.

Abstract

The BREATHE-5 study demonstrated that bosentan, an oral endothelin receptor antagonist, provides clinical benefits in patients with Eisenmenger's syndrome. As a result, the European Medicines Agency (EMEA) approved its use for this indication. However, follow-up in that study was limited to 16 weeks and patients with complex congenital heart disease were excluded. We assessed the effect of long-term bosentan treatment in 10 patients with complex congenital heart disease and Eisenmenger's syndrome. In the mean clinical follow-up period of 25 months, all patients reached the target dose without developing side effects and without experiencing a change in arterial oxygen consumption at either rest or maximal exercise. Moreover, there were significant changes in clinical parameters: NYHA functional class improved from 3.3+/-0.7 to 2.5+/-0.9 (P=.002) and the 6-minute walk distance increased from 266+/-161 m to 347+/-133 m (P=.015).

• Authors: Eva Díaz-Caraballo, Ana E González-García, Margarita Reñones, Angel Sánchez-Recalde, Francisco García-Río, José M Oliver-Ruiz
• Journal: Revista espanola de cardiologia (Rev Esp Cardiol) Vol. 62 Issue 9 Pg. 1046-9 (Sep 2009) ISSN: 1579-2242 [Electronic] Spain
• PMID: 19712626 (Publication Type: Journal Article)

Chemical References

• Endothelin Receptor Antagonists
• Sulfonamides
• Bosentan

Topics

• Adult
• Bosentan
• Eisenmenger Complex (complications, drug therapy)
• Endothelin Receptor Antagonists
• Female
• Heart Diseases (complications, congenital, drug therapy)
• Humans
• Male
• Sulfonamides (therapeutic use)
• Time Factors