Effect of sildenafil on digital ulcers in systemic sclerosis: analysis from a single centre pilot study

Abstract

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.

Figure 1

Effect of sildenafil treatment on the number of digital ulcers (DU) in patients with (A) diffuse and (B) limited systemic sclerosis (SSc) during 6 months of treatment, on (C) Raynaud's phenomenon (RP), (D) burden of pain, (E) daily activity and (F) on disease burden due to ulcers measured by visual analogue scale (VAS). A paired Wilcoxon test was used to calculate statistical significance; the median is illustrated as a horizontal line.

Figure 2

Digital ulcer healing by sildenafil treatment as shown for three different patients. Digital ulcers before treatment are shown in (A), (C) and (D); (B), (D) and (F) show the effects of sildenafil treatment; (E) and (F) come from a patient refractory to continuous intravenous iloprost treatment over 2 weeks requiring amputation and showing insufficient wound healing. Within a few days, the patient remarked at finger rewarming and subsequently progressive wound healing.