PT - JOURNAL ARTICLE AU - José Andrés Roman Ivorra AU - Carmen Pilar Simeon AU - Juan José Alegre Sancho AU - Maria Victoria Egurbide AU - Maria Jesús Castillo AU - Xavier Lloria AU - Vicent Fonollosa TI - Bosentan in Clinical Practice for Treating Digital and Other Ischemic Ulcers in Spanish Patients with Systemic Sclerosis: IBER-DU Cohort Study AID - 10.3899/jrheum.101266 DP - 2011 Jun 01 TA - The Journal of Rheumatology PG - jrheum.101266 4099 - http://www.jrheum.org/content/early/2011/05/30/jrheum.101266.short 4100 - http://www.jrheum.org/content/early/2011/05/30/jrheum.101266.full AB - Objective To describe treatment outcomes and safety experience with bosentan in patients with systemic sclerosis (SSc) and digital ulcers (DU), in a clinical setting in Spain. Methods This was a multicenter, noninterventional retrospective cohort study. Data were collected retrospectively from patients with DU, with or without pulmonary arterial hypertension (PAH), who were initiating bosentan therapy in 2003 (n = 26) or 2004 (n = 41) and followed until May 2005. Data were obtained from centers prescribing bosentan. Relevant measures included number of DU, occurrence of new DU, overall DU clinical status (improved, stabilized, worsened), and bosentan-associated adverse events. Results Sixty-seven patients with SSc and DU or other ulcers were included. PAH was also present in 12 patients (18%). At the start of bosentan treatment, the median number of DU per patient was 3.0. The median change in number of DU was –3.6 and –5.0 at 12 and 24 months, respectively. Sixty-eight percent of the patients did not develop any new DU at 12 months. DU clinical status was reported at 12 months for 22 patients: 18 patients (81.8%) improved and 4 (18.2%) stabilized. The median treatment duration was 13.0 months. The main adverse event was increase of aminotransferase, observed in 5 patients (7%), leading to discontinuation of treatment in 3 patients (4.4%). Conclusion Previously reported results of bosentan efficacy in DU management are reproducible in clinical practice. This efficacy is maintained in the longterm followup. Bosentan treatment was well tolerated and adverse events were comparable with those observed in previous reports.