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Congress: ECR24
Poster Number: C-11689
Type: EPOS Radiographer (scientific)
Authorblock: J. S. Endrikat1, A. Ullmann1, C. Gerlinger1, A. Bhatti2, P. Lengsfeld1, A. Michel3; 1Berlin/DE, 2Whippany, NJ/US, 3Basel/CH
Disclosures:
Jan Siegfried Endrikat: Author: Bayer AG Employee: Bayer AG
Alexander Ullmann: Author: Bayer AG Employee: Bayer Ag
Christoph Gerlinger: Author: Bayer AG Employee: Bayer Ag
Aasia Bhatti: Author: Bayer AG Employee: Bayer Ag
Philipp Lengsfeld: Employee: Bayer Ag Author: Bayer AG
Alexander Michel: Employee: Bayer Ag Author: Bayer AG
Keywords: Contrast agents, CT, Contrast agent-intravenous, Safety, Drugs / Reactions
Purpose To analyze the potential impact of patients’ sex, race and region/country on the risk of hypersensitivity reactions.
Read more Methods and materials Two analyses were performed.1.) The “Phase-IV-Analysis” evaluated an integrated pooled database of 4 non-interventional studies (1-4). It was a nested case-control analysis of patients who received an injection of iopromide 300 or 370mg iodine/mL. Cases were patients with a typical/unequivocal HSR.2.) The “GPV-Analysis” evaluated all case reports from the company’s global pharmacovigilance database. It was based on HSR case reports in the company database. Exposure estimates were derived from sales and market research data.
Read more Results 1.) The Phase-IV-Analysis comprised 152,233 patients from 37 countries. In the full analysis set 145,033 were included in the sex cohort, 59,412 in the race cohort and 146,649 in the region/country cohort. [fig 1] 2.) The GPV-Analysis was based on 78.72 and 118.56 million administrations for which sex or region/country exposures were estimable. [fig 2] Sex1.) The Phase-IV-Analysis: The HSR incidence was significantly higher for women (0.72%) vs. men (0.55%) (p≤0.0001). [fig 3] The unadjusted odds ratio (OR) was 1.3 (CI 1.154; 1.499), the adjusted...
Read more Conclusion Women showed a slightly higher risk for HSRs to iopromide than men. This is considered a class effect. Evidence of an impact of race was not found. HSR reporting varied slightly by region/country.
Read more References Kopp AF, Mortele KJ, Cho YD, Palkowitsch P, Bettmann MA, Claussen CD. Prevalence of acute reactions to iopromide: postmarketing surveillance study of 74,717 patients. Acta Radiol. 2008;49(8):902-11. Palkowitsch P, Lengsfeld P, Stauch K, Heinsohn C, Kwon ST, Zhang SX, Liang CH. Safety and diagnostic image quality of iopromide: results of a large non-interventional observational study of European and Asian patients (IMAGE). Acta Radiol. 2012;53(2):179-86. Palkowitsch PK, Bostelmann S, Lengsfeld P. Safety and tolerability of iopromide intravascular use: a pooled analysis of three...
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