Prostaglandin E1 incorporated in lipid microspheres in the treatment of peripheral vascular diseases and diabetic neuropathy

Abstract

Lipo-PGE1 is a drug preparation of prostaglandin E1 (PGE1) incorporated in lipid microspheres similar in properties to liposomes. A randomized, single-blind, cross-over study comparing free PGE1 (PGE1 cyclodextrine, PGE1CD) with lipo-PGE1 was performed. Twenty patients with peripheral vascular diseases and diabetic neuropathy entered the trial. The first seven days' treatment was either 5 micrograms/day of lipo-PGE1 or 40 micrograms/day of PGE1CD, followed by a seven-day wash-out period; then cross-over was performed for another week's administration. Improvements were achieved by both PGE1 preparations. The comparison between lipo-PGE1 and PGE1CD showed that the former was significantly superior, both in final global improvement (p less than 0.01) and in terms of patients' preference (p less than 0.01); lipo-PGE1 also produced fewer side-effects. This study suggests that lipo-PGE1 is a very valuable agent for the treatment of peripheral vascular disorders and diabetic neuropathy.