PMID- 28372493
OWN - NLM
STAT- MEDLINE
DCOM- 20171227
LR  - 20181113
IS  - 1600-0455 (Electronic)
IS  - 0284-1851 (Print)
IS  - 0284-1851 (Linking)
VI  - 59
IP  - 1
DP  - 2018 Jan
TI  - Safety profile of gadoxetate disodium in elderly patients (>/=65 years).
PG  - 81-88
LID - 10.1177/0284185117700673 [doi]
AB  - 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.
FAU - Endrikat, Jan
AU  - Endrikat J
AD  - 1 Bayer AG, Berlin, Germany.
AD  - 2 Department of Gynecology, Obstetrics and Reproductive Medicine, University 
      Medical School of Saarland, Homburg/Saar, Germany.
FAU - Schwenke, Carsten
AU  - Schwenke C
AD  - 3 SCO:SSiS Statistical Consulting, Berlin, Germany.
FAU - Vogtlaender, Kai
AU  - Vogtlaender K
AD  - 4 Bayer AG, Integrated Analysis & Life Cycle Management Statistics, Wuppertal, 
      Germany.
FAU - Dohannish, Susan
AU  - Dohannish S
AD  - 5 Bayer Pharmaceuticals, Pharmacovigilance and Risk Management, Whippany, NJ, 
      USA.
FAU - Breuer, Josy
AU  - Breuer J
AD  - 1 Bayer AG, Berlin, Germany.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
DEP - 20170403
PL  - England
TA  - Acta Radiol
JT  - Acta radiologica (Stockholm, Sweden : 1987)
JID - 8706123
RN  - 0 (Contrast Media)
RN  - 0 (gadolinium ethoxybenzyl DTPA)
RN  - K2I13DR72L (Gadolinium DTPA)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Age Factors
MH  - Aged
MH  - China
MH  - Contrast Media/*adverse effects
MH  - Databases, Factual
MH  - Europe
MH  - Female
MH  - Gadolinium DTPA/*adverse effects
MH  - Geriatric Assessment/*methods/statistics & numerical data
MH  - Humans
MH  - Image Enhancement/*methods
MH  - Japan
MH  - Liver/drug effects
MH  - Magnetic Resonance Imaging
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - United States
MH  - Young Adult
PMC - PMC5751856
OTO - NOTNLM
OT  - Gadoxetate disodium
OT  - elderly
OT  - safety
EDAT- 2017/04/05 06:00
MHDA- 2017/12/28 06:00
PMCR- 2018/01/03
CRDT- 2017/04/05 06:00
PHST- 2017/04/05 06:00 [pubmed]
PHST- 2017/12/28 06:00 [medline]
PHST- 2017/04/05 06:00 [entrez]
PHST- 2018/01/03 00:00 [pmc-release]
AID - 10.1177_0284185117700673 [pii]
AID - 10.1177/0284185117700673 [doi]
PST - ppublish
SO  - Acta Radiol. 2018 Jan;59(1):81-88. doi: 10.1177/0284185117700673. Epub 2017 Apr 
      3.