Efficacy of a new prostaglandin E(1) regimen in outpatients with severe intermittent claudication: Results of a multicenter placebo-controlled double-blind trial

For the first time efficacy and safety of a new prostaglandin E(1) (PGE(1)) regimen in the treatment of intermittent claudication were evaluated in a randomized, double-blind, placebo-controlled multicenter clinical trial. The study involved 213 outpatients with a maximum walking distance of 50 to 200 m measured on the treadmill (3 km/hr, 12% grade). After a 2-week run-in phase they received a 2-hour intravenous infusion of 60 mu g PGE(1) or placebo 5 days a week for 4 weeks. It was followed by a 4-week interval treatment with the same medication administered only twice a week Patients were monitored for 3 months when they received no study medication. In the PGE(1) group the intention-to-treat analysis (n = 208) revealed an increase in walking distance after 4 weeks of 75% (placebo, 43%). At the end of the interval treatment the walking distance had improved to 101% (placebo, 60%). The results remained virtually constant during follow-up (PGE(1), 104%, placebo, 63%). Between-group comparisons showed significant differences in favor of PGE, for all three time points of measurement (p < 0.05, p < 0.01, and p < 0.05). PGE, was well tolerated; the rate of adverse reactions related to the treatment was 12.8% (placebo, 7.7%). In summary, these results show that the new PGE(1) regimen is effective and safe in the treatment of outpatients with intermittent claudication.