Abstract | INTRODUCTION: METHODS: In this randomized, double-blind, placebo controlled study we enrolled 20 patients with limited SSc. Fifteen patients received ambrisentan 5 mg daily for one month and then 10 mg daily for two months, and five received a placebo. There were three visits: weeks 0 (baseline), one and 12. Three patient-oriented questionnaires were completed at each visit: Scleroderma-Health Assessment Questionnaire (S- HAQ), Raynaud Condition Score (RCS), and Pain-Visual Analog Scale (P-VAS). At each visit, LDPI was used to obtain three blood flow readings involving regions of interest in second to fifth fingers of the non-dominant hand at room temperature (25°C) and after cooling (10°C) for two minutes. RESULTS: There were 16 females (80%); mean age was 50 years. None of the differences in blood flow (as measured by LDPI) were significant both at baseline and after cooling. However, patients in the ambrisentan group showed significant improvement in the patient-oriented outcomes: RCS (P=0.001) and S- HAQ score (P=0.005). CONCLUSIONS: This pilot study did not show evidence of significant increase in digital blood flow over time; however, there was an improvement in RCS and S- HAQ score. We conclude that continuous use of ambrisentan for three months does not seem to significantly improve digital blood flow in SSc patients. TRIAL REGISTRATION: Clinicaltrials.gov NCT01072669. Registered 19 February 2010.
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Authors | Nilanjana Bose, James Bena, Soumya Chatterjee |
Journal | Arthritis research & therapy
(Arthritis Res Ther)
Vol. 17
Pg. 44
(Mar 05 2015)
ISSN: 1478-6362 [Electronic] England |
PMID | 25876611
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Phenylpropionates
- Pyridazines
- ambrisentan
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Topics |
- Adult
- Aged
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Fingers
(blood supply)
- Follow-Up Studies
- Humans
- Laser-Doppler Flowmetry
(methods)
- Male
- Microcirculation
(drug effects)
- Middle Aged
- Perfusion Imaging
(methods)
- Phenylpropionates
(administration & dosage)
- Pilot Projects
- Prospective Studies
- Pyridazines
(administration & dosage)
- Regional Blood Flow
(drug effects)
- Scleroderma, Systemic
(drug therapy, physiopathology)
- Time Factors
- Young Adult
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