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


CONCLUSIONS
Bosentan may be a safe long-term alternative for treating the recurrence of skin ulcers and healed ulcers in SSc patients.
García de la Peña-Lefebvre
P
P
Servicio de Reumatología, Hospital Ramón y Cajal, Carretera de Colmenar Km 9,100. Madrid 28034, Spain. palomalefebvre@wanadoo.es
Rodríguez Rubio
S
S
Valero Expósito
M
M
Carmona
L
L
Gámir Gámir
M L
ML
Beltrán Gutiérrez
J
J
Díaz-Miguel
C
C
Orte Martínez
J
J
Zea Mendoza
A C
AC
D000293:Adolescent; D000328:Adult; D000368:Aged; D000077300:Bosentan; D002648:Child; D065128:Endothelin Receptor Antagonists; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012595:Scleroderma, Systemic / Q000150:complications / Q000188:drug therapy*; D012720:Severity of Illness Index; D012883:Skin Ulcer / Q000188:drug therapy* / Q000209:etiology; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D065128:Endothelin Receptor Antagonists; D013449:Sulfonamides; D000077300:Bosentan