Clinical profile of ioversol. A metaanalysis of 57 randomized, double-blind clinical trials.
OBJECTIVE
The authors characterize the clinical profile of ioversol, specifically in terms of radiographic efficacy and clinical tolerance.


METHODS
Metaanalysis of data from all available randomized, double-blind trials, comparing ioversol with other nonionic contrast media in indicated procedures was conducted. A total of 3854 adult patients were studied (1931 ioversol, 1923 reference) from 57 clinical trials.


RESULTS
Ioversol was considered diagnostic in 99.3% of examinations, with good to excellent enhancement quality in 89.3% of cases. In comparative evaluations, there was a 24% odds reduction of the investigator's nondiagnostic judgment and a 15% odds reduction of poor to fair quality in favor of ioversol. For tolerance, 20.2% and 3.3% of patients in the ioversol group reported moderate to severe sensation of heat and pain with a 10% odds reduction and a 3% odds increase, respectively. The incidence of drug-related adverse events was low: 76 (3.3%) patients in the ioversol group and 62 (2.9%) patients in control group. No statistically significant differences were noted.


CONCLUSIONS
Based on these findings, the high-contrast efficacy and patient tolerance make ioversol a suitable agent, equivalent to other nonionic contrast media.
Floriani
I
I
Clinical Research Department, Byk Gulden Italia, Cormano, Italy.
Ciceri
M
M
Torri
V
V
Tinazzi
A
A
Jahn
H
H
Noseda
A
A
D000328:Adult; D000368:Aged; D015901:Angiography, Digital Subtraction; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects; D017023:Coronary Angiography; D004311:Double-Blind Method; D005260:Female; D006358:Hot Temperature; D006801:Humans; D007269:Injections, Intra-Arterial; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000139:chemically induced; D010690:Phlebography; D011856:Radiographic Image Enhancement; D016032:Randomized Controlled Trials as Topic; D012677:Sensation / Q000187:drug effects; D014057:Tomography, X-Ray Computed; D014283:Triiodobenzoic Acids / Q000008:administration & dosage / Q000009:adverse effects; D014567:Urography
D003287:Contrast Media; D014283:Triiodobenzoic Acids; C054871:ioversol