Objective In this pilot study, the effect of sildenafil on digital ulcer (DU) healing and related clinical symptoms was analysed.
Methods A total of 19 patients with systemic sclerosis (SSc) were treated with maximally tolerated sildenafil doses up to 6 months. Primary outcome was the healing of DUs. Changes in other clinical symptoms were also evaluated.
Results In all, 49 DUs were present at baseline; this decreased to 17 ulcers (p<0.001) at the end of sildenafil treatment. Furthermore, the visual analogue scale (VAS) score for Raynaud's phenomenon (RP), pain and activity improved (p=0.003, p=0.002 and p=0.05, respectively). A total of 9 patients developed 12 new DUs during sildenafil treatment.
Conclusions This study indicates an effect of sildenafil on DU healing in patients with SSc and an improvement of RP and associated symptoms that should be validated in controlled studies.
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Funding The study was supported by an unrestricted grant from Pfizer. Furthermore, the study was supported by the German Network for Systemic Sclerosis (DNSS) as well as by the EUSTAR network for assessment strategies.
Competing interests GR received lecturer's fees from Encysive, Actelion, GSK and Pfizer.
Ethics approval This study was conducted with the approval of the local ethical committee (Charité Berlin).
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent Obtained.
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