J Endrikat1, C Schwenke2, M R Prince3. 1. Department of Global Medical Affairs, Bayer HealthCare, Berlin, Germany; Saarland University Hospital, Homburg, Saar, Germany. Electronic address: jan.endrikat@bayer.com. 2. SCO:SSiS Statistical Consulting, Berlin, Germany. 3. Department of Radiology, Weill Cornell Medical College, NY, USA.
Abstract
AIM: To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18-64 years. MATERIALS AND METHODS: Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. RESULTS: Rates of reported ADRs were lower in elderly patients versus adults aged <65 years due to a reduced incidence of non-serious ADRs; this was statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. CONCLUSIONS: This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups.
AIM: To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18-64 years. MATERIALS AND METHODS: Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. RESULTS: Rates of reported ADRs were lower in elderly patients versus adults aged <65 years due to a reduced incidence of non-serious ADRs; this was statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. CONCLUSIONS: This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups.
Authors: Martin R Prince; Hae Giu Lee; Chang-Hee Lee; Sung Won Youn; In Ho Lee; Woong Yoon; Benqiang Yang; Haiping Wang; Jin Wang; Tiffany Ting-Fang Shih; Guo-Shu Huang; Jiing-Feng Lirng; Petra Palkowitsch Journal: Eur Radiol Date: 2016-03-09 Impact factor: 5.315
Authors: Nicola Schieda; Jason I Blaichman; Andreu F Costa; Rafael Glikstein; Casey Hurrell; Matthew James; Pejman Jabehdar Maralani; Wael Shabana; An Tang; Anne Tsampalieros; Christian B van der Pol; Swapnil Hiremath Journal: Can J Kidney Health Dis Date: 2018-06-12