title: Lipo-PGE1, a new lipid-encapsulated preparation of prostaglandin E1: placebo-and prostaglandin E1-controlled multicenter trials in patients with diabetic neuropathy and leg ulcers.
abstract: Several clinical trials have shown that prostaglandin E1 (PGE1) is effective in treating peripheral occlusive vascular disease, but not definitely for diabetic neuropathy. We developed a new preparation of PGE1 incorporated in lipid microspheres (lipo-PGE1) that was designed to accumulate at vascular lesions. The effect of lipo-PGE1 (10 micrograms/day) was compared with placebo and the normal dose of a free PGE1 preparation (PGE1-CD, 40 micrograms/day) in two studies (double-blind and well-controlled) which enrolled 364 diabetic patients with neuropathy and/or leg ulcers. The drugs were given intravenously (bolus or drip infusion) for 4 weeks. Clinical improvement was noted in 61.6% of the lipo-PGE1 group and 30.0% of the placebo group in Trial 1 (p < 0.01), while the figures were 58.3% in the lipo-PGE1 group and 37.1% in the PGE1-CD group in Trial 2 (p < 0.01). Leg ulcers became smaller in the lipo-PGE1 groups in both trials (p < 0.01). In Trial 2, motor conduction velocity improved in the lipo-PGE1 group (p = 0.016). Side effects occurred in few patients receiving lipo-PGE1 or placebo, but more patients developed local side effects in the PGE1-CD group (p < 0.01). Thus, bolus intravenous injection of lipo-PGE1 improved diabetic neuropathy and leg ulcers with minimal side effects.
authors.affiliation: Department of Internal Medicine, Tohoku University, Sendai, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Toyota
authors.forename: Y
authors.initials: Y
authors.lastname: Hirata
authors.forename: Y
authors.initials: Y
authors.lastname: Ikeda
authors.forename: K
authors.initials: K
authors.lastname: Matsuoka
authors.forename: A
authors.initials: A
authors.lastname: Sakuma
authors.forename: Y
authors.initials: Y
authors.lastname: Mizushima
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000527:Alprostadil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D048909:Diabetes Complications; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003929:Diabetic Neuropathies / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D004576:Electromyography; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D007564:Japan; D007700:Kinetics; D007871:Leg Ulcer / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D010919:Placebos
chemical_list: D010919:Placebos; D000527:Alprostadil