title: Safety profile of gadoxetate disodium in elderly patients (≥65 years).
abstract: Background Safety data on routine clinical use of gadoxetate disodium in elderly patients is not reported yet. Purpose To assess the safety of liver specific gadoxetate disodium in contrast enhanced magnetic resonance imaging in elderly patients (≥65 years) in comparison to adults (18-64 years). Material and Methods Safety data on gadoxetate disodium were analyzed from 12 clinical phase II-III studies and from our pharmacovigilance database. A comparison between elderly (≥65 years) versus adults (18-64 years) was performed with respect to the frequency of drug-related adverse events (AEs) in clinical phase II-III studies and adverse drug reactions (ADRs) in the pharmacovigilance database. Results In clinical studies, 1989 patients were enrolled: 675 elderly and 1314 adults. Twenty-three elderly patients (3.4%) suffered at least one drug-related AE in contrast to 58 patients (4.4%) in the group of adults (odds ratio = 0.76; 95% confidence interval = 0.45-1.27). Since marketing authorization in 2004, more than 3.5 million patients have been exposed to gadoxetate disodium worldwide: 1.7 million (48.6%) in elderly and 1.8 million (51.4%) in adults. The number of patients with post-marketing ADRs (total n = 793) was 354 (0.021%) in the elderly group and 439 (0.024%) in the adult group. Thus, there were significantly fewer patients with ADRs reported in the group of elderly versus adults ( P = 0.028). Hypersensitivity/immune system disorders, gastrointestinal disorders, and respiratory disorders were the most frequent ADRs in both groups, elderly and adults. Conclusion The incidence of drug-related AEs in clinical studies was similar and that of patients with ADRs in the post-marketing setting was lower in elderly (≥65 years) compared with younger adults aged 18-64 years. Overall, gadoxetate disodium shows a favorable safety profile in both age groups.
authors.affiliation: 1 Bayer AG, Berlin, Germany.|2 Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Homburg/Saar, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Endrikat
authors.affiliation: 3 SCO:SSiS Statistical Consulting, Berlin, Germany.
authors.forename: Carsten
authors.initials: C
authors.lastname: Schwenke
authors.affiliation: 4 Bayer AG, Integrated Analysis & Life Cycle Management Statistics, Wuppertal, Germany.
authors.forename: Kai
authors.initials: K
authors.lastname: Vogtlaender
authors.affiliation: 5 Bayer Pharmaceuticals, Pharmacovigilance and Risk Management, Whippany, NJ, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Dohannish
authors.affiliation: 1 Bayer AG, Berlin, Germany.
authors.forename: Josy
authors.initials: J
authors.lastname: Breuer
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D002681:China; D003287:Contrast Media / Q000009:adverse effects*; D016208:Databases, Factual; D005060:Europe; D005260:Female; D019786:Gadolinium DTPA / Q000009:adverse effects*; D015577:Geriatric Assessment / Q000379:methods* / Q000706:statistics & numerical data; D006801:Humans; D007089:Image Enhancement / Q000379:methods*; D007564:Japan; D008099:Liver / Q000187:drug effects; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014481:United States; D055815:Young Adult
chemical_list: D003287:Contrast Media; C073590:gadolinium ethoxybenzyl DTPA; D019786:Gadolinium DTPA
keywords: Gadoxetate disodium; elderly; safety