Efficacy of a new prostaglandin E1 regimen in outpatients with severe intermittent claudication: results of a multicenter placebo-controlled double-blind trial.
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| 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.
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| Authors | C Diehm, K Balzer, H Bisler, B Bulling, M Camci, A Creutzig, J D Gruss, S Horsch, F Odemar, U Piehler, W Rogatti, P Scheffler, F Spengel, N Treese, A Turowski, P Waldhausen, B Weber, T Weiss |
| Journal | Journal of vascular surgery (J Vasc Surg) Vol. 25 Issue 3 Pg. 537-44 (Mar 1997) ISSN: 0741-5214 [Print] United States |
| PMID | 9081136 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial) |
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