Treatment of Thromboangiitis Obliterans (Buerguer's Disease) With Bosentan
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
This study assessed the effectiveness and safety of bosentan when administered to
thromboangiitis obliterans (Buerger's disease)patients. A clinical pilot study was
designed,included in which patients with ulcer and/or pain at rest were treated with bosentan
p.o at a dose of 62,5 mg twice daily during the first month, which each thereafter uptitrated
to 125 mg twice daily. Study endpoints were clinical improvement rate, major or minor
amputation rate, hemodynamic changes, changes in endothelial function and angiographic
changes.
12 patients were included were current smokers. With bosentan treatment, no new ischemic
lesions were observed in all but one patient. Overall, clinical improvement was observed in
12 of the 13 extremities (92%). Only two of 13 extremities underwent amputation after
bosentan treatment. As assessed by digital arteriography with subtraction or angio-magnetic
resonance image an increase of distal flow was observed in 10 out of the 12 patients. All
patients experienced a statistically significant improvement in their BAFMD values (means:1.8
at baseline;6.6 at the end of the treatment;12.7 three months after the end of the
treatment;p<0.01). In conclusion: Bosentan treatment may result in an improvement of
clinical, angiographic, hemodynamic and endothelial function outcome. Bosentan deserves
further investigation in the management TAO patients.