Abstract | OBJECTIVE: 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:
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Authors | 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 |
Journal | Arthritis and rheumatism
(Arthritis Rheum)
Vol. 50
Issue 12
Pg. 3985-93
(Dec 2004)
ISSN: 0004-3591 [Print] United States |
PMID | 15593188
(Publication 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.)
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Chemical References |
- Antihypertensive Agents
- Endothelin Receptor Antagonists
- Sulfonamides
- Bosentan
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Topics |
- Activities of Daily Living
- Administration, Oral
- Antihypertensive Agents
(administration & dosage, therapeutic use)
- Bosentan
- Disability Evaluation
- Double-Blind Method
- Endothelin Receptor Antagonists
- Female
- Fingers
(blood supply)
- Health Status
- Humans
- Ischemia
(drug therapy, etiology)
- Male
- Middle Aged
- Scleroderma, Systemic
(complications, drug therapy, physiopathology)
- Severity of Illness Index
- Skin Ulcer
(etiology, physiopathology, prevention & control)
- Sulfonamides
(administration & dosage, therapeutic use)
- Surveys and Questionnaires
- Treatment Outcome
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