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) (PG E(1)) regimen in the treatment of intermittent claudication were evalu ated in a randomized, double-blind, placebo-controlled multicenter cli nical 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 infu sion of 60 mu g PGE(1) or placebo 5 days a week for 4 weeks. It was fo llowed by a 4-week interval treatment with the same medication adminis tered only twice a week Patients were monitored for 3 months when they received no study medication. In the PGE(1) group the intention-to-tr eat analysis (n = 208) revealed an increase in walking distance after 4 weeks of 75% (placebo, 43%). At the end of the interval treatment th e walking distance had improved to 101% (placebo, 60%). The results re mained virtually constant during follow-up (PGE(1), 104%, placebo, 63% ). Between-group comparisons showed significant differences in favor o f PGE, for all three time points of measurement (p < 0.05, p < 0.01, a nd p < 0.05). PGE, was well tolerated; the rate of adverse reactions r elated to the treatment was 12.8% (placebo, 7.7%). In summary, these r esults show that the new PGE(1) regimen is effective and safe in the t reatment of outpatients with intermittent claudication.