title: Efficacy of bosentan in patients with refractory thromboangiitis obliterans (Buerger disease): A case series and review of the literature.
abstract: The cornerstone of therapy in thromboangiitis obliterans (TAO) is complete abstinence from tobacco. In addition to discontinuation of cigarette smoking, very few pharmacological and surgical options of controversial efficacy are available to date. New therapeutic options with greater efficacy are clearly needed to properly manage these patients.In this preliminary study, we assessed the effectiveness and safety of bosentan in a case series of 8 adults with TAO and severe ischemic ulceronecrotic lesions who were treated with bosentan after inadequate response to platelet inhibitors, vasodilators, and intravenous alprostadil. Additionally, we reviewed 18 well-documented patients with refractory TAO treated with bosentan, which was previously reported (PubMed 1965-2015). These 26 patients formed the basis of our present analysis. All were current smokers.The median duration of bosentan treatment (SD) was 4.5 ± 4 months (range 3-16). Eleven patients (42%) were unable to completely abstain from smoking during their follow-up. With bosentan treatment, no new ischemic lesions were observed in the target extremities. A complete therapeutic response was achieved in 80% of patients, whereas a partial response was observed in 12%. Two patients (8%) ultimately required amputation despite treatment.After discontinuation of bosentan, patients were followed for a median of 20 ± 14 months (range 3-60). Two patients whose trophic lesions had healed relapsed.When comparing patients who gave up smoking with those who were unable to completely abstain from smoking during follow-up, no significant differences were found in efficacy outcomes. Four patients (15%) developed adverse events, requiring bosentan discontinuation in 1 case.These preliminary data suggest that bosentan may be considered a therapeutic option for treatment of cases of severe TAO refractory to conventional treatment, and merit further evaluation in larger controlled, randomized clinical studies.
authors.affiliation: Department of Rheumatology. Hospital Universitario de Bellvitge-IDIBELL Rheumatology Unit Department of Angiology and Vascular Surgery, Consorci Sanitari de Terrassa Department of Rheumatology, Parc Sanitari Sant Joan de Déu, Sant Boi, Barcelona, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Narváez
authors.forename: Carmen
authors.initials: C
authors.lastname: García-Gómez
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Álvarez
authors.forename: Pilar
authors.initials: P
authors.lastname: Santo
authors.forename: María
authors.initials: M
authors.lastname: Aparicio
authors.forename: María
authors.initials: M
authors.lastname: Pascual
authors.forename: Mercè
authors.initials: M
authors.lastname: López de Recalde
authors.forename: Helena
authors.initials: H
authors.lastname: Borrell
authors.forename: Joan M
authors.initials: JM
authors.lastname: Nolla
mesh_terms: D000328:Adult; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D000077300:Bosentan; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013449:Sulfonamides / Q000627:therapeutic use*; D013919:Thromboangiitis Obliterans / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D013449:Sulfonamides; D000077300:Bosentan