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.