Preventive effect of an oral prostacyclin analog, beraprost sodium, on digital necrosis in systemic sclerosis. French Microcirculation Society Multicenter Group for the Study of Vascular Acrosyndromes.
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.


CONCLUSIONS
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.
Vayssairat
M
M
Hôpital Tenon, Paris, France.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D011464:Epoprostenol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005385:Fingers / Q000098:blood supply / Q000473:pathology; D006801:Humans; D007511:Ischemia / Q000150:complications / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009336:Necrosis; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D012595:Scleroderma, Systemic / Q000150:complications* / Q000188:drug therapy; D014456:Ulcer / Q000209:etiology / Q000517:prevention & control
D000893:Anti-Inflammatory Agents; C048081:beraprost; D011464:Epoprostenol