Beraprost improves exercise capacity and symptoms in NYHA functional class II and III patients with PAH and, in particular, in those with primary pulmonary hypertension.

Background-Beraprost sodium (BPS) is a new stable, orally active prostaglandin I 2 analogue with antiplatelet and vasodilating properties. We report the results of a phase III clinical trial of BPS in patients with intermittent claudication. Methods and Results-Patients (nϭ549) with a pain-free walking distance of between 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 Ͻ25% were then randomized to receive either BPS (40 g TID, nϭ209) or placebo (nϭ213) in a double-blind manner for 6 months. Pain-free and maximum walking distances were measured on the occasion of treadmill exercise tests performed at baseline and 1.5, 3, 4.5, and 6 months after randomization. Success was defined as an improvement of Ͼ50% in pain-free walking distance at month 6 and in Ն1 earlier treadmill exercise test in the absence of critical cardiovascular events. Success was observed more frequently in the BPS group (43.5%) than in the placebo group (33.3%, Pϭ0.036). Pain-free walking distances increased by 81.5% and 52.5%, respectively, in the BPS and placebo groups (Pϭ0.001) and maximum walking distances by 60.1% and 35.0%, respectively (Pϭ0.004). The incidence of critical cardiovascular events was 4.8% in the BPS group and 8.9% in the placebo group. Conclusions-These results show that BPS is an effective symptomatic treatment of patients with intermittent claudication.The beneficial effects of BPS on critical cardiovascular events should be confirmed in appropriate clinical trials. Key Words: claudication Ⅲ beraprost sodium Ⅲ prostaglandins I ntermittent claudication is a common presentation of lower-limb arterial disease, with a prevalence of 1% to 7% in men 50 to 75 years old. 1,2 Medical therapy for patients with intermittent claudication has 2 goals: improvement of symptoms and prevention of cardiovascular events. Many agents, including vasodilators, have been tried for the relief of symptoms, although their effectiveness is still subject to debate. The antiplatelet and vasodilating properties of epoprostenol (prostaglandin [PG] I 2 ) make it a theoretically interesting agent in the treatment of peripheral vascular disease. 3 Although promising results were reported for its use in the treatment of intermittent claudication, 4 its very short half-life and high chemical instability precluded its use as a therapeutic agent and led to the development of more stable synthetic analogues. Iloprost, to date the most extensively studied of these analogues, has been shown to provide pain relief and to accelerate ulcer healing in patients with stage III or IV critical leg ischemia 5 and has been licensed in some countries for the treatment of thromboangiitis obliterans. The need for an intravenous infusion of iloprost, although acceptable for the treatment of critical ischemia, makes it unacceptable for the long-term treatment of intermittent claudication.Beraprost sodium (BPS) is a new stable, orally active PGI 2 analogue with antiplatelet and vasodilating prope...

We compared the efficacy and safety of three doses of beraprost sodium, an epoprostenol analogue, with placebo in the treatment of intermittent claudication (Fontaine's stage II). One hundred sixty-four patients were randomized to receive either placebo, 20 micrograms beraprost sodium (BPS60 group), 40 micrograms beraprost sodium (BPS120 group), or 60 micrograms beraprost sodium (BPS180 group) three times daily administered orally in a double-blind manner for 12 weeks. Treadmill exercise tests were performed twice during an initial selection phase (D-28 and D0) at week 10 (at trough beraprost concentration) and week 12 (at peak beraprost concentration) of the treatment phase. At week 10, all groups showed an increase in pain-free walking distance, and this distance was greatest in the BPS60 and BPS120 groups (p = 0.055). At week 12, a similar pattern was observed, and the difference was significant between the groups (p = 0.023). The most frequent adverse events reported were gastrointestinal disorders, headaches, skin disorders, and flushes. Patients who received either 60 or 120 micrograms of beraprost sodium daily had an increased pain-free walking distance. Further studies are required to investigate why the highest dose used (180 micrograms daily) showed lower efficacy. Having both vasodilating and antiplatelet properties and being able to increase pain-free walking distance in the short term, beraprost sodium is a promising drug for the treatment of intermittent claudication.