title: A double-blind comparative study of the safety, tolerability, and efficacy of ioversol and iohexol in peripheral and visceral arteriography.
abstract: A randomized, double-blind, parallel-group clinical study was conducted to compare the efficacy, tolerability, and safety of ioversol 320 mg I/mL (Optiray, 320 Mallinckrodt Medical, Inc., St. Louis, MO) and iohexol 300 mg I/mL (Omnipaque 300, Winthrop Pharmaceuticals, New York, NY). The study was conducted in 50 patients undergoing peripheral arteriography and in ten patients undergoing visceral arteriography. In the peripheral group, 92% of the radiographs acquired using Optiray were rated excellent or good. Eighty-eight percent of those acquired with Omnipaque were so rated. In the visceral study all radiographs in both groups were rated excellent or good. Patient tolerance was also impressive. We used a four-point rating scale (1 - none; 4 = severe) to score both heat and pain sensations. For peripheral patients the average heat score was 2.4 in the Optiray group versus 2.3 in the Omnipaque group. The average pain scores were 1.1 in both groups. For visceral patients, the average heat scores were 2.4 in both groups, while the pain scores were 1.7 for the Optiray group versus 1.0 for the Omnipaque group. No clinically significant changes in vital signs were observed in any of the patients. One clinically significant change in the electrocardiogram (ECG) tracing was noted after an Optiray injection, but it was not felt to be drug induced. There were five instances in which laboratory values rose from their normal baseline values, but all changes were minor. There was only one adverse reaction in the entire study. A short episode of coughing occurred in one patient who received Omnipaque for a peripheral study; the coughing resolved spontaneously. Both Optiray and Omnipaque proved to be efficacious, well tolerated, and safe for intra-arterial use in peripheral and visceral vessels.
authors.affiliation: Section of Cardiovascular and Interventional Radiology, St. Vincent Hospital, Indianapolis, Indiana.
authors.forename: W B
authors.initials: WB
authors.lastname: Cutcliff
authors.forename: D E
authors.initials: DE
authors.lastname: Schwarten
mesh_terms: D000005:Abdomen / Q000098:blood supply*; D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D003287:Contrast Media; D004311:Double-Blind Method; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D007463:Iodobenzoates; D007472:Iohexol / Q000633:toxicity; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D011859:Radiography; D014283:Triiodobenzoic Acids / Q000633:toxicity; D014652:Vascular Diseases / Q000000981:diagnostic imaging
chemical_list: D003287:Contrast Media; D007463:Iodobenzoates; D014283:Triiodobenzoic Acids; D007472:Iohexol; C054871:ioversol