Safety of iobitridol in the general population and at-risk patients.
The purpose of this study was to review the rate of adverse events after contrast medium administration in the general population and at-risk patients (renal impairment, heart failure (NYHA III or IV), hypotension or hypertension, coronary artery disease, previous reaction to contrast media, asthma and/or allergies, dehydration, diabetes mellitus, poor general condition) under daily practice conditions in a post-marketing surveillance study. Two hundred and ten radiologists conducted various X-ray examinations in 52,057 patients. To document the safety of iobitridol in routine use, all patients undergoing X-ray examinations were included. Exclusion criteria were contraindications listed in the locally approved summary of product characteristics. The adverse event rate was 0.96% (at-risk patients 1.39%); the rate of serious adverse events 0.044% in all patients (at-risk patients 0.057%). Adverse events occurred more often in women than in men (P < 0.001). In patients who had previously reacted to a contrast medium, adverse events were reported in 3.43% with mild to moderate symptoms. In 47.76% of these patients, a premedication was administered. There was no difference in the frequency of adverse events and serious adverse events whether premedicated or not (P = 0.311 and P = 0.295, respectively). Iobitridol was well-tolerated in 99.04% of cases (at-risk patients 98.61%).
Vogl
Thomas J
TJ
Department of Radiology, University Hospital Frankfurt, Johann Wolfgang Goethe-University, Theodor-Stern-Kai 7, 60590 Frankfurt, Germany. T.Vogel@em.uni-frankfurt.de
Honold
Elmar
E
Wolf
Michael
M
Mohajeri
H
H
Hammerstingl
R
R
D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001249:Asthma / Q000150:complications; D015992:Body Mass Index; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects*; D003327:Coronary Disease / Q000150:complications; D048909:Diabetes Complications; D005260:Female; D006801:Humans; D006967:Hypersensitivity / Q000150:complications; D006973:Hypertension / Q000150:complications; D007022:Hypotension / Q000150:complications; D007472:Iohexol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D011292:Premedication; D011358:Product Surveillance, Postmarketing; D012307:Risk Factors; D012449:Safety; D012737:Sex Factors
D003287:Contrast Media; C093233:iobitridol; D007472:Iohexol