| Digital ulcers in systemic sclerosis: prevention by treatment with bosentan, an oral endothelin receptor antagonist. | |
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MedLine Citation:
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PMID: 15593188 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: Recurrent digital ulcers are a manifestation of vascular disease in patients with systemic sclerosis (SSc; scleroderma) and lead to pain, impaired function, and tissue loss. We investigated whether treatment with the endothelin receptor antagonist, bosentan, decreased the development of new digital ulcers in patients with SSc. METHODS: This was a randomized, prospective, placebo-controlled, double-blind study of 122 patients at 17 centers in Europe and North America, evaluating the effect of treatment on prevention of digital ulcers. The primary outcome variable was the number of new digital ulcers developing during the 16-week study period. Secondary assessments included healing of existing digital ulcers and evaluation of hand function using the Scleroderma Health Assessment Questionnaire. RESULTS: Patients receiving bosentan had a 48% reduction in the mean number of new ulcers during the treatment period (1.4 versus 2.7 new ulcers; P = 0.0083). Patients who had digital ulcers at the time of entry in the study were at higher risk for the development of new ulcers; in this subgroup the mean number of new ulcers was reduced from 3.6 to 1.8 (P = 0.0075). In patients receiving bosentan, a statistically significant improvement in hand function was observed. There was no difference between treatment groups in the healing of existing ulcers. Serum transaminase levels were elevated to >3-fold the upper limit of normal in bosentan-treated patients; this elevation is comparable with that observed in previous studies of this agent. Other side effects were similar in the 2 treatment groups. CONCLUSION: Endothelins may play an important role in the pathogenesis of vascular disease in patients with SSc. Treatment with the endothelin receptor antagonist bosentan may be effective in preventing new digital ulcers and improving hand function in patients with SSc. |
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Authors:
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J H Korn; M Mayes; M Matucci Cerinic; M Rainisio; J Pope; E Hachulla; E Rich; P Carpentier; J Molitor; J R Seibold; V Hsu; L Guillevin; S Chatterjee; H H Peter; J Coppock; A Herrick; P A Merkel; R Simms; C P Denton; D Furst; N Nguyen; M Gaitonde; Carol Black |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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Title: Arthritis and rheumatism Volume: 50 ISSN: 0004-3591 ISO Abbreviation: Arthritis Rheum. Publication Date: 2004 Dec |
Date Detail:
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Created Date: 2004-12-15 Completed Date: 2005-01-13 Revised Date: 2007-11-14 |
Medline Journal Info:
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Nlm Unique ID: 0370605 Medline TA: Arthritis Rheum Country: United States |
Other Details:
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Languages: eng Pagination: 3985-93 Citation Subset: AIM; IM |
Affiliation:
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Boston University School of Medicine, Boston, MA 02118, USA. jkorn@bu.edu |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Activities of Daily Living Administration, Oral Antihypertensive Agents / administration & dosage, therapeutic use* Disability Evaluation Double-Blind Method Female Fingers / blood supply Health Status Humans Ischemia / drug therapy, etiology Male Middle Aged Questionnaires Receptors, Endothelin / antagonists & inhibitors* Scleroderma, Systemic / complications, drug therapy*, physiopathology Severity of Illness Index Skin Ulcer / etiology, physiopathology, prevention & control* Sulfonamides / administration & dosage, therapeutic use* Treatment Outcome |
| Grant Support | |
ID/Acronym/Agency:
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M01-RR-00533/RR/NCRR NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Antihypertensive Agents; 0/Receptors, Endothelin; 0/Sulfonamides; 147536-97-8/bosentan |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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