Safety and tolerability of iobitridol in general and in patients with risk factors: results in more than 160,000 patients.
OBJECTIVE
To review the safety, the tolerability and the diagnostic effectiveness of iobitridol under daily practice conditions in the general population and at-risk patients in a post-marketing surveillance study.


METHODS
A total of 160,639 patients (55.1% male, 43.6% female, mean age 58.6 years) were analysed in 555 centers. Patients underwent X-ray examinations using iobitridol (Xenetix®, Guerbet, Sulzbach, Germany) as IV contrast medium (mean volume 85.6 ml). 21.8% of all patients had at least one risk factor (e.g., renal impairment), 7.3% were at-risk patients with allergies or who had previously reacted to contrast medium. Antiallergic pretreatment before contrast medium administration was given in 1144 patients (0.7%). Adverse events were documented and the image quality was assessed.


RESULTS
A diagnosis was possible in 99.5% of all cases. The image quality was rated good or excellent in 92.2%. The adverse event rate (e.g., nausea, urticaria) observed was 0.6% in all patients, 1.6% in patients with allergies and 6.0% in patients with a previous reaction to contrast medium. Adverse events occurred more often in women than in men (p<0.001). Pretreatment did not decrease the rate of adverse events. The rate of adverse events was not increased in higher doses of iobitridol, even if administered to high-risk patients.


CONCLUSIONS
Iobitridol was shown to be a safe and well-tolerated contrast medium with a low incidence of adverse events in patients with and without risk factors resulting in a good or excellent image quality in most patients.
Maurer
Martin
M
Charité-University Medicine Berlin, Department of Radiology, Augustenburger Platz 1, 13353 Berlin, Germany. martin.maurer@charite.de
Heine
Oliver
O
Wolf
Michael
M
Freyhardt
Patrick
P
Schnapauff
Dirk
D
Hamm
Bernd
B
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007472:Iohexol / Q000009:adverse effects / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D012307:Risk Factors; D014057:Tomography, X-Ray Computed
D003287:Contrast Media; C093233:iobitridol; D007472:Iohexol