Safety of gadodiamide injection in two different age groups.
A meta-analyses was performed to evaluate the safety of gadodiamide injection (OM-NISCAN) for magnetic resonance imaging in two different age groups (< 65 years; > or = 65 years). Data on vital signs, clinical laboratory parameters, and subjectively experienced adverse events were reviewed for 734 patients included in 19 European 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 statistically 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 in frequency between the two age groups. Injection-associated discomfort was significantly (P = .0025) more frequent in the younger (9.2%) than in the older group (2.5%). Gadodiamide injection is in conclusion a safe contrast medium in older as well as in younger patients.
Högström
B
B
Clinical Research and Development, Nycomed Imaging AS, Oslo, Norway.
Kristoffersen
D T
DT
Lundby
B
B
Svaland
M G
MG
D000328:Adult; D000367:Age Factors; D000368:Aged; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D019786:Gadolinium DTPA; D006801:Humans; D007275:Injections, Intravenous; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000009:adverse effects*; D004369:Pentetic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
D003287:Contrast Media; D009942:Organometallic Compounds; D004369:Pentetic Acid; C064925:gadodiamide; D019786:Gadolinium DTPA