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Safety and tolerability of bosentan for digital ulcers in Japanese patients with systemic sclerosis: Prospective, multicenter, open-label study.
- Source :
-
The Journal of dermatology [J Dermatol] 2017 Jan; Vol. 44 (1), pp. 13-17. Date of Electronic Publication: 2016 Jul 04. - Publication Year :
- 2017
-
Abstract
- A multicenter, open-label study was performed to investigate the safety and tolerability of bosentan in Japanese patients with systemic sclerosis (SSc) and secondary digital ulcers. Twenty-eight patients were enrolled. The safety and tolerability of bosentan was monitored over 52 weeks of study treatment (primary end-point), while incidence and healing of digital ulcers were also assessed up to week 16. The following adverse events occurred in 5% or more of patients during the 52-week treatment period: upper respiratory tract infection (50.0%), abnormal liver function tests (42.9%), digital ulcers (25.0%), anemia (17.9%), peripheral edema (14.3%), diarrhea (10.7%), urinary tract infection (7.1%), arthralgia (7.1%), constipation (7.1%) and herpes zoster (7.1%). Eight patients experienced at least one serious adverse event, including drug-related serious adverse events in two patients, which were abnormal liver function tests and fluid retention (pericardial effusion) in one patient each. During the 16-week observation period, seven out of 28 patients (25%) developed new digital ulcers. In this study, adverse events were comparable with those previously reported with bosentan. Approximately half of the patients had adverse events associated with abnormal liver function tests, thus we conclude that liver function should be monitored regularly during treatment with bosentan.<br /> (© 2016 Japanese Dermatological Association.)
- Subjects :
- Administration, Oral
Adult
Aged
Anemia chemically induced
Arthralgia chemically induced
Bosentan
Constipation chemically induced
Diarrhea chemically induced
Endothelin Receptor Antagonists administration & dosage
Endothelin Receptor Antagonists therapeutic use
Female
Fingers
Herpes Zoster chemically induced
Humans
Japan
Liver drug effects
Liver Function Tests
Male
Middle Aged
Prospective Studies
Scleroderma, Systemic blood
Skin Ulcer blood
Skin Ulcer etiology
Sulfonamides administration & dosage
Sulfonamides therapeutic use
Treatment Outcome
Endothelin Receptor Antagonists adverse effects
Scleroderma, Systemic complications
Skin Ulcer drug therapy
Sulfonamides adverse effects
Wound Healing drug effects
Subjects
Details
- Language :
- English
- ISSN :
- 1346-8138
- Volume :
- 44
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- The Journal of dermatology
- Publication Type :
- Academic Journal
- Accession number :
- 27374274
- Full Text :
- https://doi.org/10.1111/1346-8138.13497