Meta-analysis of randomised controlled prostaglandin E1 studies in peripheral arterial occlusive disease stages III and IV

Background: The relevance of Prostaglandin E-1 (PGE(1)) in the treatment of peripheral arterial occlusive disease stage III and IV was to be evaluated for the first time by a meta-analysis. Patients and methods: Altogether, 643 patients were, analyzed from seven randomized, controlled PGE(1) studies that were comparable with regard to patient selection, study design and endpoints. Of these, only placebo-controlled studies (n = 254) were included in the formal meta-analysis using the method of DerSimonian and Laird. Additionally, the response rate and the rate of adverse events were determined for the pooled groups of all studies. Results: At the end of treatment, PGE(1) showed a significantly better response (ulcer healing and/or pain reduction) as compared to placebo (47.8% for PGE(1) vs. 25.2% for-placebo, p = 0.0294). A significant difference in favor of PGE(1) was also seen for the combined endpoint "major amputation or death" after 6-month follow-up (22.6% for PGE(1) vs. 36.2% for placebo, p = 0.0150). The response rate (ulcer healing and/or pain relief) of the pooled treatment groups was 60.2% for PGE(1), 25.2% for placebo, and 53.6%,for iloprost. The adverse events rate of the pooled treatment groups showed good tolerability for PGE(1) with a rate of 39.6% in comparison to 73.9% for iloprost and 15.4% for placebo. Conclusion: For patients with peripheral arterial occlusive disease stage III or IV not eligible for arterial reconstruction, PGE(1) therapy not only has significant beneficial effects over placebo on ulcer healing and pain relief, but also increases the rate of patients surviving with both legs after 6-months follow-up.