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Modified-release sildenafil reduces Raynauds phenomenon attack frequency in limited cutaneous systemic sclerosis
Arthritis & Rheumatism, 03/02/2011
Clinical Article
Herrick AL et al. –The objective of this study was To examine the effect of sildenafil in patients with Raynaud's phenomenon (RP) secondary to limited cutaneous systemic sclerosis (lcSSc). These findings indicate that modified-release sildenafil reduced attack frequency in patients with RP secondary to lcSSc and was well tolerated. Modified-release sildenafil may be a treatment option in this patient population.
Methods- Double-blind, placebo-controlled study
- 57 patients with RP secondary to lcSSc randomized to receive modified-release sildenafil 100 mg once daily for 3 days followed by modified-release sildenafil 200 mg once daily for 25 days or placebo
- Primary assessment percentage change in number of RP attacks per week in per-protocol population
- Secondary end points included Raynaud's Condition Score, duration of attacks, RP pain score, endothelial dysfunction assessed by peripheral arterial tonometric (PAT) device, and serum biomarker levels
- Mean percentage reduction from baseline to day 28 in attacks per week greater for modified-release sildenafil than for placebo (-44.0% versus -18.1%, P = 0.034); the mean number of attacks per week improved from 25.0 at baseline to 19.3 after placebo treatment and from 30.5 to 18.7 after modified-release sildenafil treatment (P = 0.244)
- Decreases from baseline in Raynaud's Condition Score, duration of attacks, and RP pain score not significantly different between groups
- Mean values and changes from baseline in PAT responses and serum biomarker levels were similar between groups
- Most frequent AE headache and dyspepsia
- Majority of AE mild or moderate
