SAFETY OF GADODIAMIDE INJECTION IN 2 DIFFERENT AGE-GROUPS

A meta-analyses was performed to evaluate the safety of gadodiamide in jection (OMNISCAN(R)) for magnetic resonance imaging in two different age groups (< 65 years: greater than or equal to 65 years), Data on vi tal signs, clinical laboratory parameters, and subjectively experience d adverse events were reviewed for 734 patients included in 19 Europea n Phase II and III trials with gadodiamide injection (0.1 mmol/kg body weight or 0.3 mmol/kg body weight) used in magnetic resonance imaging . One hundred sixty-four patients were 65 years of age or older. No st atistically significant differences were shown between this population and the population younger than 65 years of age with respect to vital signs or clinical laboratory parameters, A total of 48 adverse events , discomfort excluded, were reported, with no significant difference i n frequency between the two age groups. Injection-associated discomfor t was significantly (P=.0025) more frequent in the younger (9.2%) than in the older group (2.5%), Gadodiamide injection is in conclusion a s afe contrast medium in older as well as in younger patients.