Risk of Hypersensitivity Reactions to Iopromide in Children and Elderly: An Analysis of 132,850 Patients From 4 Observational Studies and Pharmacovigilance Covering >288 Million Administrations

Jan Endrikat, Julia Chernova, Christoph Gerlinger, Marcin Pracz, Philipp Lengsfeld, Aasia Bhatti, Alexander Michel, Jan Endrikat, Julia Chernova, Christoph Gerlinger, Marcin Pracz, Philipp Lengsfeld, Aasia Bhatti, Alexander Michel

Abstract

Purpose: The aim of this study was to analyze the risk of hypersensitivity reactions (HSRs) to iopromide in children and elderly patients in comparison to adults.

Materials and methods: Four observational studies were pooled and analyzed (analysis I). In addition, spontaneous reports from 1985 to 2020 from the pharmacovigilance database were evaluated (analysis II). All patients received iopromide for angiographic procedures or contrast-enhanced computed tomography in various indications. In analysis I, a nested case-control analysis, including a multivariable logistic regression model, based on pooled observational study data, was performed. Cases were defined as patients with a typical and unequivocal HSR; controls were patients without any recorded reaction. In analysis II, all spontaneous reports on HSRs after iopromide administration recorded in the pharmacovigilance database were descriptively analyzed. Exposure estimates on the size of the exposed age groups were derived from sales data and data from market research. The primary target variable was the risk of HSR to iopromide in children (<18 years) and elderly patients (≥65 years) compared with adults (≥18 to <65 years).

Results: In analysis I, a total of 132,850 patients were included (2978 children, 43,209 elderly, and 86,663 adults). Hypersensitivity reactions were significantly less frequent in children (0.47%) and elderly (0.38%) compared with adults (0.74%). The adjusted odds ratio (vs adults) for children was 0.58 (95% confidence interval, 0.34-0.98; P < 0.043), and that for the elderly was 0.51 (95% confidence interval, 0.43-0.61; P < 0.001), indicating a lower risk for both subpopulations as compared with adults. In analysis II, of the overall >288 million iopromide administrations, 5.87, 114.18, and 167.97 million administrations were administered to children, elderly, and adults, respectively. The reporting rate for HSRs in children (0.0114%) and elderly (0.0071%) was significantly lower as compared with adults (0.0143%) (P < 0.0001).

Conclusions: Hypersensitivity reactions to iopromide were significantly less frequent in children and elderly compared with adults.

Trial registration: ClinicalTrials.gov NCT04605471.

Conflict of interest statement

Conflicts of interest and sources of funding: All authors are employees of Bayer.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.

Figures

FIGURE 1
FIGURE 1
Disposition of patients.
FIGURE 2
FIGURE 2
Hypersensitivity reactions in observational studies (analysis I) and pharmacovigilance database (analysis II).
FIGURE 3
FIGURE 3
Occurrence of clinically most relevant hypersensitivity reactions in analysis I (cutoff ≥0.1% in at least 1 study group).

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Source: PubMed

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