Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data.
OBJECTIVE
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.


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.
Department of Global Medical Affairs, Bayer HealthCare, Berlin, Germany; Saarland University Hospital, Homburg, Saar, Germany. Electronic address: jan.endrikat@bayer.com.
J
J
Endrikat
SCO:SSiS Statistical Consulting, Berlin, Germany.
C
C
Schwenke
Department of Radiology, Weill Cornell Medical College, NY, USA.
M R
MR
Prince
D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D003287:Contrast Media / Q000009:adverse effects*; D016208:Databases, Factual; D016903:Drug Monitoring; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D015994:Incidence; D008279:Magnetic Resonance Imaging / Q000009:adverse effects* / Q000379:methods; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D055815:Young Adult
D003287:Contrast Media; D009942:Organometallic Compounds; C090600:gadobutrol