CLINICAL PROFILE OF IOVERSOL - A METAANALYSIS OF 57 RANDOMIZED, DOUBLE-BLIND CLINICAL-TRIALS

RATIONALE AND OBJECTIVES. The authors characterize the clinical profil e of ioversol, specifically in terms of radiographic efficacy and clin ical tolerance, METHODS. Metaanalysis of data from all available rando mized, double-blind trials, comparing ioversol with other nonionic con trast media in indicated procedures was conducted, A total of 3854 adu lt patients were studied (1931 ioversol, 1923 reference) from 57 clini cal trials, RESULTS. Ioversol was considered diagnostic in 99.3% of ex aminations, with good to excellent enhancement quality in 89.3% of cas es, 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% o f patients in the ioversol group reported moderate to severe sensation of heat and pain with a 10% odds reduction and a 3% odds increase, re spectively, 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, CONCLUSIO N. Based on these findings, the high-contrast efficacy and patient tol erance make ioversol a suitable agent, equivalent to other nonionic co ntrast media.