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Treatment of Digital Ulcers in Scleroderma with Sildenafil (a sort of positive RCT)

June 11 2015 9:54 AM ET via RheumReports RheumReports

Half the patients with scleroderma have digital ulcers. At any visit approximately 15% have ulcers in whom 15% are complicated (infected, requiring amputation, etc) so ulcers are not trivial. They cause pain and poor function when present and may heal with tuft resorption (pits). Digital ulcers according to EULAR/EUSTAR guidelines should be treated by improving blood flow/Raynaud’s with the use of calcium channel blockers (CCBs) and then consider intravenous iloprost.1 Experts have reported that often their second line treatment is the use of PDE5 inhibitors as an add on to CCBs or instead of them (switching).2 Aspirin and pain medications can be considered. In a meta-analysis, there seemed to be improvement in digital ulcers for SSc patients using PDE5 inhibitors.3

Dr. Hachulla presented a RCT of sildenafil 20 mg tid over 12 weeks (OP0058) in the treatment of digital ulcers using time to complete healing in a multi-site study from France. Eighty-four patients had 192 digital ulcers (103 in placebo and 89 in slidenafil). There was a numerical faster healing (by approx 1 week), less new ulcers and differences were found to be statistically significant by 8 weeks. Time to healing was significant in the subgroup on bosentan as background therapy. Unfortunately the study was negative with many p values around 0.1 favoring sildenafil. Interestingly in this study both RP and hand function were not different between the two groups perhaps explained by lack of reversible vasospasm in long standing patients with SSc digital ulcer complications and/or background use of usual RP treatment (CCBs) where necessary.

So, I think the take home message is that PDE5 inhibitors have a role in the treatment (healing and prevention) of digital ulcers in SSc and that this study was slightly underpowered. Hopefully data such as these when added to other trials (such as RP meta-analyses of PDE5 inhibitor studies) can help for approval (drug coverage) for our patients with SSc and clinically relevant digital ulcers. We don’t know how long to use this treatment (?seasonally, continuously, for a period of time such as a month or two after ulcers have healed, etc). RCTs will not be able to answer these clinical questions.

1. Kowal-Bielecka O, et al. ARD 19 Jan 2009

2. Walker K, et al. Semin Arthritis Rheum 2012 Aug;42(1):42-55.

3. Tingey T, et al. J Rheumatol 2012;39(8):1742-3.


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About the Author

Dr. Janet Pope
Dr. Janet Pope

Dr. Janet Pope is Professor of Medicine at Western University and Division Head of Rheumatology. Dr. Pope's research interests include epidemiologic studies in scleroderma, classification criteria in systemic sclerosis, systemic lupus erythematosus and rheumatoid arthritis.

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