Post-Marketing Surveillance of the Safety Profile of Iodixanol in the Outpatient CT Setting: A Prospective, Multicenter, Observational Study of Patient Risk Factors, Adverse Reactions and Preventive Measures in 9953 Patients

Abstract

Purpose: Non-interventional study in outpatient, contrast-enhanced CT 1. to determine the extent of preventive measures for risk reduction of adverse drug reactions after contrast-enhanced CT examinations. 2. to prospectively determine the incidence and severity of adverse drug reactions occurring after administration of the iso-osmolar contrast medium iodixanol 3. to determine a possible influence of preventive measures on the incidence/severity of adverse drug reactions. Materials and Methods: Evaluable documentation was provided for 9953 patients from 66 radiology centers across Germany. Patient characteristics, aspects of iodixanol administration, and adverse events with an at least "possible" relationship were documented on a standardized case report form (CRF) and were evaluated up to seven days after contrast medium administration. Results: About 55.5 % of patients showed one or more risk factors (e. g. impaired renal function 4.4 %, diabetes mellitus 8.5 %, hypertension 20.6 %). One third of the sites did not implement any preventive measures. Patients with a known risk for an allergy-like reaction were more likely to receive pharmacologic preventive treatment (0.5 -50.5 %). Oral hydration was the main preventive measure in patients with renal risk factors (< 8 %) followed by intravenous hydration (1 %). Adverse drug reactions, mainly hypersensitivity reactions, occurred in 77 patients (0.74 %), but were classified as serious in only 3 patients (0.03 %). No statistically significant correlation between risk factors, preventive measures, and adverse reactions could be found. Conclusion: The use of preventive measures for CT examinations in this outpatient setting was generally low with risk patients being pre-medicated This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.

Deconvolution Analysis of the Non-Ionic Iomeprol, Iobitridol and Iodixanol Contrast Media-Treated Human Whole Blood Thermograms: A Comparative Study

“…Contrast media are widely used in routine medical imaging, such as CT, X-ray and MRI [1][2][3]. The administration of contrast media results in physical interaction with either the intra-or extracellular components of the cells and may influence the conformation and function of proteins, leading to the development of severe conditions, such as thyroid dysfunctions, hypersensitivity and contrast agent-induced nephropathy (CIN) [54,55]. To reduce the likelihood of interaction, non-ionic contrast media are being used more often nowadays.…”

Effect of Different Iodine Concentrations on Patient-Reported Discomfort in Contrast-Enhanced Computed Tomography: A Prospective Comparative Trial

“…This enabled us to significantly reduce the injection rate in the 400 mg/ml study group. While many studies focus on acute and late adverse reactions [15][16][17], this study evaluates the patient's experience as the main item of acceptance. We observed only minor differences in the patient-reported, contrast-injection-related sensations of heat, taste and pain between both of our study groups (300 mg/ml vs. 400 mg/ml).…”

Retrospective Analysis of Acute Adverse Reactions of 4 Iodine Contrast Agents

“…According to the report in this paper, the incidence of acute adverse reactions and severe adverse reactions of 7 kinds of iodine contrast agents were 1.03% and 0.0141% respectively. The incidence of ADR from high to low respectively Iomeprol, Iohexol, Iopamidol, ioversol, iodixanol, iopromide, iobitridol [1] Among them, iodixanol is a new type of non-ionic dimer iso-osmolar contrast agent, which is well tolerated and has a low incidence of adverse reactions according to some studies on Visipaque, the original agent of iodixanol [2] [3]. Aidixian is the generics of iodixanol in China rstly produced by Jiangsu Hengrui Pharmaceutical Co. LTD. For its clinical application, there is still a lack of corresponding clinical data.…”