Microcirculation and tolerability following i.v. infusion of PGE1 and iloprost: a randomized cross-over study in patients with critical limb ischemia

• Published in: Prostaglandins, leukotrienes and essential fatty acids Vol. 70; no. 6; pp. 503 - 509
• Main Authors: SCHELLONG, S, ALTMANN, E, VON BILDERLING, P, RUDOFSKY, G, WALDHAUSEN, P, ROGATTI, W
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier 01.06.2004
• Subjects: Aged; Aged, 80 and over; Alprostadil - administration & dosage; Alprostadil - pharmacology; Alprostadil - therapeutic use; Biological and medical sciences; Cross-Over Studies; Drug Tolerance; Female; Fundamental and applied biological sciences. Psychology; Humans; Iloprost - administration & dosage; Iloprost - pharmacology; Iloprost - therapeutic use; Infusions, Intravenous; Ischemia - drug therapy; Ischemia - pathology; Leg - blood supply; Male; Microcirculation - drug effects; Vasodilator Agents - administration & dosage; Vasodilator Agents - pharmacology; Vertebrates: endocrinology; Vascular disease; Human; Microcirculation; Nervous system diseases; Randomization; Ischemia; Cardiovascular disease
• ISSN: 0952-3278; 1532-2823
• DOI: 10.1016/j.plefa.2003.10.006

In a randomized cross-over study, the effect of PGE(1) and iloprost on microcirculation as well as the tolerability was investigated in 36 patients with peripheral arterial occlusive disease stage III and IV according to Fontaine. Patients received PGE(1) and iloprost by single 3-h i.v. infusions on two different days at doses recommended by the manufacturers or in previous studies (PGE(1): first hour 20 microg, next 2h 30 microg each. Iloprost: first hour 0.5 ng/kg/min, next 2h 1.0 ng/kg/min). Transcutaneous oxygen pressure (tcPO(2)) values increased much more with PGE(1). Median tcPO(2) increase over baseline 30 min after the end of infusion was 9 and 2 mmHg for PGE(1) and iloprost, respectively, corresponding to median AUC differences from baseline of 1050 and 210 min mmHg. Because of its exploratory character, the study was not powered to test for significance. Adverse effects occurred in 19.4% (PGE(1)) and 30.6% (iloprost) of patients. Dose reduction was required in 3 patients receiving iloprost (hypotension, nausea, irritation of the infused vein), and in none receiving PGE(1).