Risk of Hypersensitivity Reactions to Iopromide in Children and Elderly: An Analysis of 132,850 Patients From 4 Observational Studies and Pharmacovigilance Covering288 Million Administrations
| Autor: | Julia Chernova, Aasia Bhatti, Marcin Pracz, Christoph Gerlinger, Jan Endrikat, Philipp Lengsfeld, Alexander Michel |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
medicine.medical_specialty medicine.diagnostic_test business.industry Iohexol Iopromide Computed tomography General Medicine Logistic regression Drug Hypersensitivity Reporting rate Pharmacovigilance Age groups Internal medicine Case-Control Studies medicine Humans Radiology Nuclear Medicine and imaging Observational study business Child medicine.drug Aged |
| Zdroj: | Investigative radiology. 57(5) |
| ISSN: | 1536-0210 |
| Popis: | 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.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 to65 years).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; P0.043), and that for the elderly was 0.51 (95% confidence interval, 0.43-0.61; P0.001), indicating a lower risk for both subpopulations as compared with adults. In analysis II, of the overall288 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%) (P0.0001).Hypersensitivity reactions to iopromide were significantly less frequent in children and elderly compared with adults. |
| Databáze: | OpenAIRE |
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