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Rheumatology Advance Access originally published online on February 7, 2008
Rheumatology 2008 47(4):464-466; doi:10.1093/rheumatology/ken001
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© The Author 2008. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Long-term experience of bosentan for treating ulcers and healed ulcers in systemic sclerosis patients

P. García de la Peña-Lefebvre1, S. Rodríguez Rubio1, M. Valero Expósito1, L. Carmona2, M. L. Gámir Gámir1, J. Beltrán Gutiérrez1, C. Díaz-Miguel1, J. Orte Martínez1 and A. C. Zea Mendoza1

1Servicio de Reumatología, Hospital Ramón y Cajal and 2Research Unit, Spanish Foundation of Rheumatology, Madrid, Spain.

Correspondence to: P. García de la Peña-Lefebvre, Servicio de Reumatología, Hospital Ramón y Cajal, Carretera de Colmenar Km 9,100. Madrid 28034, Spain. E-mail: palomalefebvre{at}wanadoo.es


  Abstract

Objectives. Our objective was to evaluate the efficacy and tolerability of bosentan in patients with systemic sclerosis (SSc) who develop ulcers and healed ulcers. We also wanted to analyse the effect of bosentan on other skin and general outcome measurements.

Methods. In the present prospective, observational, non-controlled study, we followed all patients with SSc who started treatment with bosentan for ischaemic ulcers and healed ulcers from January 2003 to June 2006 in our centre. We recorded skin and general outcome measurements at baseline and at 6 months.

Results. Fifteen patients were included. After a median follow-up of 24.7 months (range: 4–36), there was a significant decrease in the number of ulcers. A trend towards efficacy was seen in the number of healed ulcers and in the severity of ulcers. No significant effect was seen in other skin and general outcome measurements. Toxicity related to bosentan included mild transitory events and one toxic hepatitis.

Conclusion. Bosentan may be a safe long-term alternative for treating the recurrence of skin ulcers and healed ulcers in SSc patients.

KEY WORDS: Systemic sclerosis, Bosentan, Ulcers, Healed ulcers

Submitted 6 July 2007; revised version accepted 2 January 2008.
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