title: Ioversol clinical safety summary.
abstract: The authors evaluated double-blind comparative and open-label clinical trials in 1,186 patients who received ioversol to evaluate the safety and efficacy of ioversol, a new nonionic low-osmolality contrast medium, at iodine concentrations of 32%, 24%, and 16%. The results indicate that ioversol was well tolerated in all patients and showed fewer adverse effects than conventional ionic agents. The diagnostic efficacy of ioversol was comparable to both conventional and other nonionic agents with respect to diagnostic quality. However, the improved patient tolerance may contribute to higher quality radiographs. The effects on renal function were monitored at 24, 48, 72, and 96 hours and did not reveal any clinically or statistically significant changes.
authors.affiliation: Mallinckrodt Medical, Inc., St. Louis, Missouri 63134.
authors.forename: M
authors.initials: M
authors.lastname: Benamor
authors.forename: E M
authors.initials: EM
authors.lastname: Aten
authors.forename: K D
authors.initials: KD
authors.lastname: McElvany
authors.forename: D G
authors.initials: DG
authors.lastname: Lankin
authors.forename: M A
authors.initials: MA
authors.lastname: James
authors.forename: T
authors.initials: T
authors.lastname: Buy-Gandal
authors.forename: L T
authors.initials: LT
authors.lastname: Harashe
authors.forename: W J
authors.initials: WJ
authors.lastname: Weinandt
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000792:Angiography / Q000379:methods*; D002986:Clinical Trials as Topic; D003287:Contrast Media / Q000009:adverse effects*; D004311:Double-Blind Method; D004361:Drug Tolerance; D006801:Humans; D007391:International Cooperation; D007463:Iodobenzoates; D008875:Middle Aged; D014283:Triiodobenzoic Acids / Q000009:adverse effects; D014652:Vascular Diseases / Q000000981:diagnostic imaging*
chemical_list: D003287:Contrast Media; D007463:Iodobenzoates; D014283:Triiodobenzoic Acids; C054871:ioversol