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A randomized controlled trial to compare the safety and effectiveness of doxycycline (200 mg daily) with oral prednisolone (0.5 mg kg(-1) daily) for initial treatment of bullous pemphigoid : a protocol for the Bullous Pemphigoid Steroids and Tetracyclines (BLISTER) trial
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Chalmers, J. R., Wojnarowska, F., Kirtschig, G., Nunn, A. J., Bratton, D. J., Mason, James, Foster, K. A., Whitham, D. and Williams, H. C. (2015) A randomized controlled trial to compare the safety and effectiveness of doxycycline (200 mg daily) with oral prednisolone (0.5 mg kg(-1) daily) for initial treatment of bullous pemphigoid : a protocol for the Bullous Pemphigoid Steroids and Tetracyclines (BLISTER) trial. British Journal of Dermatology, 173 (1). pp. 227-34. doi:10.1111/bjd.13729 ISSN 0007-0963.
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Official URL: http://dx.doi.org/10.1111/bjd.13729
Abstract
Background:
Bullous pemphigoid (BP) is the most common autoimmune blistering disease in older people, and is associated with significant morbidity and mortality. Oral corticosteroids are usually effective but the side-effects are thought to contribute to the high morbidity and mortality rate. Treatment with oral tetracyclines may be effective but high-quality, randomized controlled trials (RCTs) are needed to confirm this.
Objectives:
To compare the effectiveness and safety of two strategies for treating BP.
Methods:
This is a two-arm, parallel group, 52-week RCT comparing doxycycline with prednisolone for initial treatment of BP. Dose is fixed for the initial 6 weeks of treatment (doxycycline 200 mg daily; prednisolone 0·5 mg kg−1 daily), after which it can be adjusted according to need. A total of 256 patients with BP will be recruited in the U.K. and Germany.
Results:
The primary outcomes are: (i) effectiveness (assessor-blinded blister count at 6 weeks) and (ii) safety [proportion of patients experiencing ≥ grade 3 adverse events (i.e. severe, life: threatening or fatal) related to trial medication during the year of follow-up]. Primary effectiveness analysis will be an assessment of whether doxycycline can be considered noninferior to prednisolone after 6 weeks of treatment. Primary safety analysis is a superiority analysis at 12 months. Secondary outcomes include longer-term assessment of effectiveness, relapse rates, the proportion of patients experiencing any grade of adverse events related to treatment, quality of life and cost-effectiveness.
Conclusions:
The trial will provide good evidence for whether the strategy of starting BP treatment with doxycycline is a useful alternative to prednisolone.
| Item Type: | Journal Article | ||||||
|---|---|---|---|---|---|---|---|
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Journal or Publication Title: | British Journal of Dermatology | ||||||
| Publisher: | Wiley-Blackwell Publishing Ltd. | ||||||
| ISSN: | 0007-0963 | ||||||
| Official Date: | July 2015 | ||||||
| Dates: |
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| Volume: | 173 | ||||||
| Number: | 1 | ||||||
| Page Range: | pp. 227-34 | ||||||
| DOI: | 10.1111/bjd.13729 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Restricted or Subscription Access |
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