Oral beraprost sodium, a prostaglandin I-2 analogue, for intermittent claudication - A double-blind, randomized, multicenter controlled trial

Background-Beraprost sodium (BPS) is a new stable, orally active prostaglan din I, analogue with antiplatelet and vasodilating properties. We report th e results of a phase III clinical trial of BPS in patients with intermitten t claudication. Methods and Results-Patients (n=549) with a pain-free walking distance of b etween 50 and 300 m were entered into a 4-week single-blind placebo run-in phase. Patients whose pain-free walking distance had changed by <25% were t hen randomized to receive either BPS (40 mu g TID, n=209) or placebo (n=213 ) in a double-blind manner for 6 months. Pain-free and maximum walking dist ances were measured on the occasion of treadmill exercise tests performed a t baseline and 1.5, 3, 4.5, and 6 months after randomization. Success was d efined as an improvement of >50% in pain-free walking distance at month 6 a nd in greater than or equal to 1 earlier treadmill exercise test in the abs ence of critical cardiovascular events. Success was observed more frequentl y in the BPS group (43.5%) than in the placebo group (33.3%, P=0.036). Pain -free walking distances increased by 81.5% and 52.5%, respectively, in the BPS and placebo groups (P=0.001) and maximum walking distances by 60.1% and 35.0%, respectively (P=0.004). The incidence of critical cardiovascular ev ents was 4.8% in the BPS group and 8.9% in the placebo group. Conclusions-These results show that BPS is an effective symptomatic treatme nt of patients with intermittent claudication. The beneficial effects of BP S on critical cardiovascular events should be confirmed in appropriate clin ical trials.