Clinical experience with iomeprol in myelography and myelo-CT - Clinical pharmacology and double-blind comparisons with iopamidol, iohexol, and iotrolan

RATIONALE AND OBJECTIVES. TO evaluate iomeprol, a new nonionic iodinated co ntrast medium, as a contrast agent for myelography and to compare it with i opamidol, iohexol, and iotrolan, METHODS. An extensive clinical program was conducted on more than 600 patie nts to assess iomeprol's pharmacokinetics, tolerability, safety, and effica cy after intrathecal injection. RESULTS. Pharmacokinetics study results showed that after intrathecal admin istration iomeprol is completely absorbed from the cerebrospinal fluid comp artment; once absorbed into the systemic circulation, it is rapidly excrete d, unmetabolized, by glomerular filtration, Dose-finding studies showed tha t the opacification produced by iomeprol depends on the injected dose. Alth ough a dose-dependent increase in efficacy was observed, no differences in neurotolerability and safety were detected between the doses tested. Doses of iomeprol greater than 3 g I did not cause a greater incidence of adverse events and produced significantly better contrast efficacy. Comparative cl inical trials showed that iomeprol and iopamidol, iohexol, and iotrolan alw ays provided adequate opacification of the subarachnoid space, both in conv entional myelography and myelo-CT, with adequate delineation of normal stru ctures and pathologic processes. No serious adverse events occurred up to a total dose of 4.5 g I. No differences between the agents with regard to to lerance, adverse events, and effects on vital signs, physical examination, and neurologic examination were observed. CONCLUSIONS. Iomeprol is safe and effective and can be recommended for myel ography and myelo-CT.