Efficacy of a new prostaglandin E1 regimen in outpatients with severe intermittent claudication: Results of a multicenter placebo-controlled double-blind trial

Abstract

For the first time efficacy and safety of a new prostaglandin E1 (PGE1) 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 micrograms PGE1 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 PGE1 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 (PGE1, 104%, placebo, 63%). Between-group comparisons showed significant differences in favor of PGE1 for all three time points of measurement (p < 0.05, p < 0.01, and p < 0.05). PGE1 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 PGE1 regimen is effective and safe in the treatment of outpatients with intermittent claudication.

Oral Beraprost Sodium, a Prostaglandin I 2 Analogue, for Intermittent Claudication

“…[21][22][23] The largest published study 21 evaluated 213 patients with a maximum walking distance of 50 to 200 m at treadmill exercise. PGE 1 was infused 5 days a week for 4 weeks.…”

Nutritional therapy for peripheral arterial disease: a double-blind, placebo-controlled, randomized trial of HeartBar®

“…31 Likewise, prostaglandin E 1 , when given intravenously for 5 days per week for 4 weeks and then twice weekly for 4 additional weeks, resulted in a 37% increase in walking distance over the placebo group. 32 Finally, Brevetti and colleagues have performed a number of studies examining the clinical effect of propionyl l-carnitine in patients with intermittent claudication. In the largest of these studies, these investigators found no difference in walking distances from placebo over the course of the study until 180 days of intervention.…”

Spinal cord stimulation for patients with inoperable chronic critical leg ischemia

“…Nevertheless, quite a few patients are unsuitable for operation. Despite technical progress, the treatment of patients with inoperable chronic CLI is still challenging; most of the patients have to undergo amputation: [6][7][8][9] 33% at 6 months and 51% at 2 years. [10] SCS has been recommended to treat ischemic pain and prevent amputation in patients with inoperable CLI.…”