A MULTICENTER DOUBLE-BLIND CONTROLLED-STUDY OF LIPO-PGE1, PGE1 INCORPORATED IN LIPID MICROSPHERES, IN PERIPHERAL VASCULAR-DISEASE SECONDARY TO CONNECTIVE-TISSUE DISORDERS

  • 1 February 1987
    • journal article
    • research article
    • Vol. 14  (1) , 97-101
Abstract
Lipo-PGE1 is a drug preparation of PGE1 (prostaglandin E1) incorporated in lipid microspheres similar in properties to liposomes. A multicenter, placebo controlled, double blind test of lipo-PGE1 was carried out in patients with severe peripheral vascular disease secondary to diffuse connective tissue disorders. A total of 135 patients received a 90 min intravenous infusion of either 10 .mu.g lipo-PGE1 or placebo every day for 4 weeks. A significant improvement was noted in the lipo-PGE1 group compared with the placebo group in the final overall improvement of peripheral vascular disease (p < 0.001) and in the healing of ulcers (p < 0.01), whereas, there was no difference in Raynaud''s syndrome between the 2 groups. Side effects in the lipo-PGE1 group were few and were no different from controls. These results indicate that lipo-PGE1 at a low dose is beneficial in the treatment of peripheral vascular disease, and that lipid microspheres are useful as a drug delivery system for such purpose.