Evaluation of iopentol (Imagopaque 350) in CT enhancement. A multi-centre monitoring trial assessing adverse events and diagnostic information--results from 1,823 patients in France.
OBJECTIVE
To evaluate the safety and efficacy of iopentol 350 mg I/ml (Imagopaque/Ivépaque, Nycomed Imaging AS, Oslo, Norway), a monomeric non-ionic contrast medium for computed tomography, in a large population. To identify predictive factors for patient safety.


METHODS
One thousand eight hundred and twenty-three (1,823) patients from 48 centres in France were included during a 5-month period. Safety was evaluated by registering adverse events (AEs) reported by the patients, and data were analysed using a multiple factor model.


RESULTS
Only 2.6% of the patients experienced AEs other than discomfort. There were no serious AEs. Overall, AEs were more frequent in patients under 50 years of age, in women, and in patients who received contrast medium as a single bolus. Contrast enhancement was considered adequate or better in 98.9% of the patients. A large variation in discomfort (local warmth/chill or pain) frequency was seen between centres, ranging from 0% to 81%. This result implies that factors other than the CM influence the incidence of discomfort.


CONCLUSIONS
This first study in a large population shows that iopentol 350 mg I/ml is well tolerated and provides CT images of excellent, good or adequate quality in the vast majority of patients. Age, sex and injection procedure were shown to be independent predictors in the AE survey.
Oxaal
M
M
Nycomed Imaging AS, Oslo, Norway.
Lambrechts
M
M
Bunouf
P
P
Menuet
J F
JF
D003287:Contrast Media / Q000009:adverse effects*; D004349:Drug Packaging; D005069:Evaluation Studies as Topic; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D012449:Safety; D014057:Tomography, X-Ray Computed; D014283:Triiodobenzoic Acids / Q000009:adverse effects*
D003287:Contrast Media; D014283:Triiodobenzoic Acids; C053571:iopentol