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Clinical profile of ioversol. A metaanalysis of 57 randomized, double-blind clinical trials
I Floriani1, M Ciceri, V Torri
1Clinical Research Department, Byk Gulden Italia, Cormano, Italy.
Rationale And Objectives:
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.
Conclusion:
Based on these findings, the high-contrast efficacy and patient tolerance make ioversol a suitable agent, equivalent to other nonionic contrast media.