title: Bosentan in clinical practice for treating digital and other ischemic ulcers in Spanish patients with systemic sclerosis: IBER-DU cohort study.
abstract: 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%).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Rheumatology Department, Hospital Universitario La Fe, Valencia, Spain. roman_jan@gva.es
authors.forename: José Andrés
authors.initials: JA
authors.lastname: Roman Ivorra
authors.forename: Carmen Pilar
authors.initials: CP
authors.lastname: Simeon
authors.forename: Juan José
authors.initials: JJ
authors.lastname: Alegre Sancho
authors.forename: Maria Victoria
authors.initials: MV
authors.lastname: Egurbide
authors.forename: Maria Jesús
authors.initials: MJ
authors.lastname: Castillo
authors.forename: Xavier
authors.initials: X
authors.lastname: Lloria
authors.forename: Vicent
authors.initials: V
authors.lastname: Fonollosa
mesh_terms: D000959:Antihypertensive Agents / Q000627:therapeutic use; D000077300:Bosentan; D015331:Cohort Studies; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D007511:Ischemia / Q000473:pathology*; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D012595:Scleroderma, Systemic / Q000150:complications* / Q000188:drug therapy* / Q000473:pathology; D012883:Skin Ulcer / Q000188:drug therapy* / Q000209:etiology* / Q000473:pathology; D013030:Spain; D013449:Sulfonamides / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D013449:Sulfonamides; D000077300:Bosentan