AI Article Synopsis

  • The study evaluated the safety of gadobutrol for MRI in Japan through post-marketing surveillance over two years.
  • Approximately 3337 patients participated, receiving an average gadobutrol dose of 0.10 mL/kg, and the incidence of adverse reactions was found to be low at 0.99%.
  • Overall, gadobutrol demonstrated a good safety profile, with 91.1% of imaging results rated as improved, and no cases of nephrogenic systemic fibrosis reported.

Article Abstract

Purpose: 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.

Results: 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.

Conclusion: Gadobutrol was well tolerated with a good safety profile in this post-marketing surveillance of a large patient population in Japan.

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Source
http://dx.doi.org/10.1007/s11604-018-0778-4DOI Listing

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