FRIDAY, March 18 (HealthDay News) -- Modified-release sildenafil reduces frequency of attacks in patients with Raynaud's phenomenon (RP) secondary to limited cutaneous systemic sclerosis (lcSSc), and is generally well tolerated, according to a study published in the March issue of Arthritis & Rheumatism.
Ariane L. Herrick, M.D., from the University of Manchester in the United Kingdom, and colleagues assessed the effect of sildenafil for the treatment of RP secondary to lcSSc. A total of 57 patients were randomized to receive either 100 mg modified-release sildenafil once a day for three days, followed by 200 mg once a day for 25 days, or placebo. The primary end point was the percentage change in the number of RP attacks per week measured in the per-protocol population. Raynaud's Condition score, attack duration, RP pain score, endothelial dysfunction, and serum biomarker levels were also measured.
The researchers found that the mean percentage reduction in weekly attacks from baseline to day 28 was significantly greater for patients treated with sildenafil (−44 percent) than placebo (−18.1 percent). The mean number of attacks per week decreased from 25 at baseline to 19.3 after placebo treatment and from 30.5 to 18.7 after modified-release sildenafil, but this change was not significant. There were no significant differences between the two groups in decreases from baseline in any of the secondary outcome measures. The majority of adverse events were moderate or mild, most commonly headache or dyspepsia.
"These results, taken together with the well-characterized safety profile of sildenafil in non-SSc patient populations, suggest that modified-release sildenafil may be of benefit as a treatment option in patients with RP secondary to lcSSc," the authors write.
Several authors disclosed financial ties with various pharmaceutical companies, including Pfizer Inc., which funded this study.