(Circulation. 2000;102:426.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
Oral Beraprost Sodium, a Prostaglandin I2 Analogue, for Intermittent Claudication
A Double-Blind, Randomized, Multicenter Controlled Trial
From the Service de Pharmacologie Clinique, Hôpitaux de Lyon (M.L., J.-P.B); Laboratoires Hoechst Marion Roussel, Paris-La Défense (S.M., B.B.); and Service de Médecine Interne, Hôpital Broussais, Paris (J.-N.F.), France.
Correspondence to Dr M. Lièvre, Service de Pharmacologie Clinique, Faculté RTH Laennec, rue Guillaume Paradin, BP 80711, 69376, Lyon Cedex 08, France. E-mail ml{at}upcl.univ-lyon1.fr
Background—Beraprost sodium (BPS) is a new stable, orally active prostaglandin I2 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 (n=549) 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 <25% were then randomized to receive either
BPS (40 µg TID, n=209) or placebo (n=213) 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 >50% in pain-free walking distance at month 6 and in
1 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%,
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 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 • beraprost sodium • prostaglandins
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