Objective: To compare the efficacy of 6 to 12 months of beraprost sodium (BPS) therapy with placebo in the prevention of digital ulceration in patients with systemic sclerosis (SSc).
Methods: One hundred seven patients with SSc were randomized in a multicenter double blind prospective trial. The primary endpoints were the percentage of patients with new digital ulceration, and median survival without recurrence of digital ulceration. Other secondary outcome measures included disability due to Raynaud's phenomenon, overall patient well being, the need for hospitalization, and endothelial damage, evaluated by variations in biological markers and nailfold microscopy.
Results: There was a trend towards fewer digital ulcerations in the BPS group than the placebo group (48.1 vs 58.8%, delta = 10.7%, p = 0.325), and median survival without recurrence of digital ulceration was longer in the BPS group (log-rank test, p = 0.233). Overall well being improved significantly more in the BPS group (p = 0.047), and von Willebrand factor decreased significantly more in the BPS group (p = 0.0001). The trend towards fewer digital ulcerations was more markedly in favor of BPS in the distal SSc group (delta for digital ulceration = 20.9%, p = 0.248) with a later onset (log-rank test, p = 0.057). Fewer patients were hospitalized in the BPS than the placebo group (4.0 vs 17.4%, p = 0.18). Side effects were mild.
Conclusion: Our study suggests that oral beraprost sodium may benefit patients with SSc. Such patients, especially those with distal SSc, tend to have fewer recurrent ischemic digital ulcerations in winter, and the onset of their ulceration is delayed.