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Risk of Hypersensitivity Reactions to Iopromide After Intra-Arterial Versus Intravenous Administration: A Nested Case-Control Analysis of 133,331 Patients.

Abstract

OBJECTIVE

The aim of this study was to compare the risk of hypersensitivity reactions to iopromide after intra-arterial (IA) administration and intravenous (IV) administration.

MATERIALS AND METHODS

Four observational studies were pooled. Almost half of the study population (48.1%) was from Europe, and one quarter each from China (27.6%) and other Asia countries (24.1%). All patients received iopromide either intra-arterially or intravenously for angiographic procedures (mostly cardio-angiography) or contrast-enhanced computed tomography. A nested case-control analysis, including a multivariable logistic regression model, was performed. Cases were defined by patients with a typical and unequivocal hypersensitivity (assumed non-IgE-mediated) reaction; controls were patients without any recorded reaction. The primary target variable is the odds ratio of having a hypersensitivity reaction after IA versus IV administration.

RESULTS

A total of 133,331 patients met the inclusion criteria, 105,460 and 27,871 patients received iopromide IV or IA, respectively. Hypersensitivity reactions were recorded for 822 patients, and 132,509 patients served as controls.Major risk factors for hypersensitivity reactions were method of injection (IV vs IA), age (18 to <50 years vs ≥65 years), history of allergy or previous contrast media reaction (all P < 0.001), and asthma (P = 0.005).A total of 766 patients (0.7%) and 56 patients (0.2%) were recorded with hypersensitivity reactions after IV or IA administration, respectively (P < 0.0001).Adjusted odds ratio (IA vs IV) was 0.23 (95% confidence interval, 0.16-0.32) for all countries together: for China only, 0.22 (0.11-0.44); for all countries without China, 0.36 (0.25-0.53).Most frequent reactions were erythema/urticaria/rash, pruritus, and cough/sneezing.

CONCLUSIONS

Hypersensitivity reactions to iopromide were significantly less frequently recorded after IA administrations. This could be related to the delayed and diluted arrival of iopromide to the lungs.

Authors+Show Affiliations

From the Bayer AG, Radiology R&D, Berlin. Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Homburg/Saar, Germany.Bayer Consumer Care AG, Division Pharmaceuticals, Epidemiology, Basel, Switzerland.PAREXEL International GmbH, Berlin.From the Bayer AG, Radiology R&D, Berlin.Bayer AG, Medical Affairs Statistics, Wuppertal, Germany.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31524764

Citation

Endrikat, Jan, et al. "Risk of Hypersensitivity Reactions to Iopromide After Intra-Arterial Versus Intravenous Administration: a Nested Case-Control Analysis of 133,331 Patients." Investigative Radiology, 2019.
Endrikat J, Michel A, Kölbach R, et al. Risk of Hypersensitivity Reactions to Iopromide After Intra-Arterial Versus Intravenous Administration: A Nested Case-Control Analysis of 133,331 Patients. Invest Radiol. 2019.
Endrikat, J., Michel, A., Kölbach, R., Lengsfeld, P., & Vogtländer, K. (2019). Risk of Hypersensitivity Reactions to Iopromide After Intra-Arterial Versus Intravenous Administration: A Nested Case-Control Analysis of 133,331 Patients. Investigative Radiology, doi:10.1097/RLI.0000000000000611.
Endrikat J, et al. Risk of Hypersensitivity Reactions to Iopromide After Intra-Arterial Versus Intravenous Administration: a Nested Case-Control Analysis of 133,331 Patients. Invest Radiol. 2019 Sep 12; PubMed PMID: 31524764.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Risk of Hypersensitivity Reactions to Iopromide After Intra-Arterial Versus Intravenous Administration: A Nested Case-Control Analysis of 133,331 Patients. AU - Endrikat,Jan, AU - Michel,Alexander, AU - Kölbach,Ralf, AU - Lengsfeld,Philipp, AU - Vogtländer,Kai, Y1 - 2019/09/12/ PY - 2019/9/17/entrez JF - Investigative radiology JO - Invest Radiol N2 - OBJECTIVE: The aim of this study was to compare the risk of hypersensitivity reactions to iopromide after intra-arterial (IA) administration and intravenous (IV) administration. MATERIALS AND METHODS: Four observational studies were pooled. Almost half of the study population (48.1%) was from Europe, and one quarter each from China (27.6%) and other Asia countries (24.1%). All patients received iopromide either intra-arterially or intravenously for angiographic procedures (mostly cardio-angiography) or contrast-enhanced computed tomography. A nested case-control analysis, including a multivariable logistic regression model, was performed. Cases were defined by patients with a typical and unequivocal hypersensitivity (assumed non-IgE-mediated) reaction; controls were patients without any recorded reaction. The primary target variable is the odds ratio of having a hypersensitivity reaction after IA versus IV administration. RESULTS: A total of 133,331 patients met the inclusion criteria, 105,460 and 27,871 patients received iopromide IV or IA, respectively. Hypersensitivity reactions were recorded for 822 patients, and 132,509 patients served as controls.Major risk factors for hypersensitivity reactions were method of injection (IV vs IA), age (18 to <50 years vs ≥65 years), history of allergy or previous contrast media reaction (all P < 0.001), and asthma (P = 0.005).A total of 766 patients (0.7%) and 56 patients (0.2%) were recorded with hypersensitivity reactions after IV or IA administration, respectively (P < 0.0001).Adjusted odds ratio (IA vs IV) was 0.23 (95% confidence interval, 0.16-0.32) for all countries together: for China only, 0.22 (0.11-0.44); for all countries without China, 0.36 (0.25-0.53).Most frequent reactions were erythema/urticaria/rash, pruritus, and cough/sneezing. CONCLUSIONS: Hypersensitivity reactions to iopromide were significantly less frequently recorded after IA administrations. This could be related to the delayed and diluted arrival of iopromide to the lungs. SN - 1536-0210 UR - https://www.unboundmedicine.com/medline/citation/31524764/Risk_of_Hypersensitivity_Reactions_to_Iopromide_After_Intra-Arterial_Versus_Intravenous_Administration:_A_Nested_Case-Control_Analysis_of_133,331_Patients L2 - http://dx.doi.org/10.1097/RLI.0000000000000611 DB - PRIME DP - Unbound Medicine ER -