Safety profile of gadoxetate disodium in elderly patients (≥65 years)

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.