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[Iomeprol: results of clinical trials with a new nonionic contrast medium in children]
R van Gessel1, A Möller, E Schmiedel
1Bracco-Byk Gulden GmbH, Konstanz.
Insights
Iomeprol, a new nonionic contrast medium, was well-tolerated in pediatric patients across various imaging procedures. This study confirms its suitability for use in children undergoing radiologic, urologic, and cardiologic examinations.
Area of Science:
- Radiology
- Pediatrics
- Pharmacology
Background:
- Nonionic contrast media are crucial for diagnostic imaging.
- Assessing the safety and tolerability of new contrast agents in pediatric populations is essential.
Purpose of the Study:
- To evaluate the tolerability and safety of the novel nonionic contrast medium, Iomeprol, in pediatric patients.
- To determine the adverse event profile of Iomeprol in a diverse pediatric age group.
Main Methods:
- Open-label, phase III studies involving 438 pediatric patients (1 day to 17 years).
- Iomeprol administered in concentrations from 150 to 400 mg iodine/ml.
- Half of the participants were under 3 years of age.
Main Results:
- Most adverse events were mild, including transient sensations of heat, pain, and taste.
- Reported adverse events, independent of causal relationship, included vomiting (1.8%), elevated blood pressure (1.8%), and restlessness (1.1%).
- All other adverse events occurred in less than 1% of patients.
Conclusions:
- Iomeprol demonstrates a favorable tolerability profile in pediatric patients.
- The nonionic contrast medium is suitable for various pediatric radiologic, urologic, and cardiologic examinations.
- Iomeprol is a safe and effective contrast agent for pediatric imaging.
Purpose:
To assess the tolerability of the newly developed nonionic contrast medium Iomeprol in pediatric patients.
Material And Methods:
A total of 438 patients (1 day-17 years) were enrolled in open-label phase III studies with Iomeprol in the most important radiologic, urologic, and cardiologic indications. Iomeprol was tested in five concentrations ranging from isotonic solutions of 150 mg iodine/ml up to 400 mg iodine/ml. Half of the patients were younger than 3 years.
Results:
Apart from the mostly slight sensations of heat, pain, and taste, the following adverse events were observed independently of a causal relationship to the test compound: vomiting (1.8%), rise in blood pressure (1.8%), and restlessness (1.1%). The respective incidence of all other adverse events was below 1%.
Conclusion:
Iomeprol is a suitable and well-tolerated nonionic contrast medium for use in pediatric examinations.