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Digital ulcers in systemic sclerosis: prevention by treatment with bosentan, an oral endothelin receptor antagonist.
Arthritis Rheum. 2004 Dec; 50(12):3985-93.AR

Abstract

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.

Authors+Show Affiliations

Boston University School of Medicine, Boston, MA 02118, USA. jkorn@bu.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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.

Language

eng

PubMed ID

15593188

Citation

Korn, J H., et al. "Digital Ulcers in Systemic Sclerosis: Prevention By Treatment With Bosentan, an Oral Endothelin Receptor Antagonist." Arthritis and Rheumatism, vol. 50, no. 12, 2004, pp. 3985-93.
Korn JH, Mayes M, Matucci Cerinic M, et al. Digital ulcers in systemic sclerosis: prevention by treatment with bosentan, an oral endothelin receptor antagonist. Arthritis Rheum. 2004;50(12):3985-93.
Korn, J. H., Mayes, M., Matucci Cerinic, M., Rainisio, M., Pope, J., Hachulla, E., Rich, E., Carpentier, P., Molitor, J., Seibold, J. R., Hsu, V., Guillevin, L., Chatterjee, S., Peter, H. H., Coppock, J., Herrick, A., Merkel, P. A., Simms, R., Denton, C. P., ... Black, C. (2004). Digital ulcers in systemic sclerosis: prevention by treatment with bosentan, an oral endothelin receptor antagonist. Arthritis and Rheumatism, 50(12), 3985-93.
Korn JH, et al. Digital Ulcers in Systemic Sclerosis: Prevention By Treatment With Bosentan, an Oral Endothelin Receptor Antagonist. Arthritis Rheum. 2004;50(12):3985-93. PubMed PMID: 15593188.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Digital ulcers in systemic sclerosis: prevention by treatment with bosentan, an oral endothelin receptor antagonist. AU - Korn,J H, AU - Mayes,M, AU - Matucci Cerinic,M, AU - Rainisio,M, AU - Pope,J, AU - Hachulla,E, AU - Rich,E, AU - Carpentier,P, AU - Molitor,J, AU - Seibold,J R, AU - Hsu,V, AU - Guillevin,L, AU - Chatterjee,S, AU - Peter,H H, AU - Coppock,J, AU - Herrick,A, AU - Merkel,P A, AU - Simms,R, AU - Denton,C P, AU - Furst,D, AU - Nguyen,N, AU - Gaitonde,M, AU - Black,Carol, PY - 2004/12/14/pubmed PY - 2005/1/14/medline PY - 2004/12/14/entrez SP - 3985 EP - 93 JF - Arthritis and rheumatism JO - Arthritis Rheum. VL - 50 IS - 12 N2 - 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. SN - 0004-3591 UR - https://www.unboundmedicine.com/medline/citation/15593188/Digital_ulcers_in_systemic_sclerosis:_prevention_by_treatment_with_bosentan_an_oral_endothelin_receptor_antagonist_ L2 - https://doi.org/10.1002/art.20676 DB - PRIME DP - Unbound Medicine ER -