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Eur Radiol. 2006 Jun;16(6):1288-97. Epub 2006 Jan 21.

Safety of iobitridol in the general population and at-risk patients.

Author information

1
Department of Radiology, University Hospital Frankfurt, Johann Wolfgang Goethe-University, Theodor-Stern-Kai 7, 60590 Frankfurt, Germany. T.Vogel@em.uni-frankfurt.de

Abstract

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%).

PMID:
16429272
DOI:
10.1007/s00330-005-0061-9
[Indexed for MEDLINE]

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