Post-marketing surveillance of gadobutrol for contrast-enhanced magnetic resonance imaging in Japan
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To evaluate the safety of gadobutrol for magnetic resonance imaging in a prospective, non-interventional, post-marketing surveillance in Japan.
Materials and methods
Gadobutrol was administered in accordance with Japanese prescribing information over a 2-year enrollment period, using a standardized questionnaire to collect information. The primary outcome was the incidence of adverse reactions (ARs) following gadobutrol injection.
Questionnaire data were analyzed for 3337 patients (age, 58.1 ± 17.4 years [mean±SD]). Gadobutrol was administered at a dose of 0.10 ± 0.02 mL/kg body weight. Thirty-three patients were observed to have 42 ARs suspected to be due to gadobutrol, an incidence proportion of 0.99%; 29 ARs were acute (<1 h post-injection)—including one case of severe acute AR (0.03%). Patient subpopulations (with hepatic, renal, cardiovascular diseases) did not differ markedly in AR proportions categorized by age, sex, presence of comorbidity, or imaging indication. No cases of nephrogenic systemic fibrosis were reported. Investigators rated images as improved or profoundly improved following gadobutrol injection in 91.1% of examinations.
Gadobutrol was well tolerated with a good safety profile in this post-marketing surveillance of a large patient population in Japan.
KeywordsGadobutrol Gadolinium-based contrast agents Magnetic resonance imaging (MRI) Post-marketing surveillance
This surveillance was funded by Bayer Yakuhin, Ltd. Editorial assistance was provided by Bill Wolvey of PAREXEL, which was funded by Bayer Yakuhin, Ltd.
Compliance with ethical standards
Conflict of interest
YT has no conflict of interest. KA received lecture fees and honoraria for chairman from Bayer Yakuhin, Ltd. GS is an employee of Bayer Yakuhin, Ltd. HM is an employee of Bayer Yakuhin, Ltd. MC is an employee of Bayer Yakuhin, Ltd. TS is an employee of Bayer Yakuhin, Ltd. JE is an employee of Bayer AG.
Ethical standards and informed consent
This surveillance was conducted in compliance with the GPSP and GVP of the Ministry of Health, Labor and Welfare in Japan. Approval by the ethics committee of each institution was not mandatory, since GPSP and GVP do not require such approval for a PMS. Informed consent from each patient was waived
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