Jan Endrikat, Alexander Ullmann, Christoph Gerlinger, Aasia Bhatti, Philipp Lengsfeld, Alexander Michel
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Cases had typical/unequivocal HSRs as defined by the ACR Committee on Drugs and Contrast Media 2018.The GPV-Analysis was based on HSR case reports in the company database. Exposure estimates were derived from sales/market research data.</p><p><strong>Results: </strong>The Phase-IV-Analysis comprised 152,233 patients from 37 countries. In the full-analysis-set 145,033, 59,412 and146,649 patients were included in the sex, race and region/country cohort, respectively. The GPV-Analysis was based on 78.72 million administrations for sex and 118.56 million administrations for region/country. No GPV exposure data by race was available.</p><p><strong>Sex: </strong>Phase-IV-Analysis: The HSR-incidence was significantly higher for women (0.72%) vs. men (0.55%) (p ≤ 0.0001). The unadjusted odds ratio (OR) was 1.3 (CI 1.154; 1.499), the adjusted OR was 1.156 (CI 1.006; 1.328) (p = 0.04).GPV-Analysis: Reporting rates were 0.0102% for women and 0.0075% for men (p < 0.0001). OR: 1.36 (CI 1.3; 1.43).</p><p><strong>Race: </strong>Phase-IV-Analysis: No significantly different HSR incidences for white (0.70%) and Asian (0.61%) patients (p = 0.3094) were detected.</p><p><strong>Region/country: </strong>Phase-IV-Analysis: The overall world HSR-incidence was 0.62%. Europe: 0.52%, Asia: 0.70%, USA: 0.75%, Germany: 0.51%, China: 0.41%, South Korea: 0.76%.GPV-Analysis: The overall world HSR-reporting rate was 0.015%, varying across regions/countries.</p><p><strong>Conclusion: </strong>Women showed a slightly higher risk for HSRs than men. Impact of race was not found. HSR-reporting varied by region/country.</p><p><strong>Advances in knowledge: </strong>Risk for HSRs was increased by female sex but not by race or region/country.</p>","PeriodicalId":9306,"journal":{"name":"British Journal of Radiology","volume":null,"pages":null},"PeriodicalIF":1.8000,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Does the Risk of Hypersensitivity Reactions to Iopromide Differ by Sex, Race or across Regions/Countries? 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Cases had typical/unequivocal HSRs as defined by the ACR Committee on Drugs and Contrast Media 2018.The GPV-Analysis was based on HSR case reports in the company database. Exposure estimates were derived from sales/market research data.</p><p><strong>Results: </strong>The Phase-IV-Analysis comprised 152,233 patients from 37 countries. In the full-analysis-set 145,033, 59,412 and146,649 patients were included in the sex, race and region/country cohort, respectively. The GPV-Analysis was based on 78.72 million administrations for sex and 118.56 million administrations for region/country. No GPV exposure data by race was available.</p><p><strong>Sex: </strong>Phase-IV-Analysis: The HSR-incidence was significantly higher for women (0.72%) vs. men (0.55%) (p ≤ 0.0001). The unadjusted odds ratio (OR) was 1.3 (CI 1.154; 1.499), the adjusted OR was 1.156 (CI 1.006; 1.328) (p = 0.04).GPV-Analysis: Reporting rates were 0.0102% for women and 0.0075% for men (p < 0.0001). OR: 1.36 (CI 1.3; 1.43).</p><p><strong>Race: </strong>Phase-IV-Analysis: No significantly different HSR incidences for white (0.70%) and Asian (0.61%) patients (p = 0.3094) were detected.</p><p><strong>Region/country: </strong>Phase-IV-Analysis: The overall world HSR-incidence was 0.62%. Europe: 0.52%, Asia: 0.70%, USA: 0.75%, Germany: 0.51%, China: 0.41%, South Korea: 0.76%.GPV-Analysis: The overall world HSR-reporting rate was 0.015%, varying across regions/countries.</p><p><strong>Conclusion: </strong>Women showed a slightly higher risk for HSRs than men. Impact of race was not found. 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Does the Risk of Hypersensitivity Reactions to Iopromide Differ by Sex, Race or across Regions/Countries? An Analysis of 152,233 Patients from Four Observational Studies and the Company's Pharmacovigilance Database.
Objective: To analyze the potential impact of patients' sex, race and region/country on the risk of hypersensitivity reactions after intra-venous or intra-arterial administration of iopromide.
Methods: Two analyses were performed. 1.) The "Phase-IV-Analysis" evaluated an integrated pooled database of 4 non-interventional studies. 2.) The "GPV-Analysis" evaluated case reports from the company's pharmacovigilance database.The Phase-IV-Analysis was a nested case-control analysis of patients who received an injection of iopromide 300/370 mg iodine/mL. Cases had typical/unequivocal HSRs as defined by the ACR Committee on Drugs and Contrast Media 2018.The GPV-Analysis was based on HSR case reports in the company database. Exposure estimates were derived from sales/market research data.
Results: The Phase-IV-Analysis comprised 152,233 patients from 37 countries. In the full-analysis-set 145,033, 59,412 and146,649 patients were included in the sex, race and region/country cohort, respectively. The GPV-Analysis was based on 78.72 million administrations for sex and 118.56 million administrations for region/country. No GPV exposure data by race was available.
Sex: Phase-IV-Analysis: The HSR-incidence was significantly higher for women (0.72%) vs. men (0.55%) (p ≤ 0.0001). The unadjusted odds ratio (OR) was 1.3 (CI 1.154; 1.499), the adjusted OR was 1.156 (CI 1.006; 1.328) (p = 0.04).GPV-Analysis: Reporting rates were 0.0102% for women and 0.0075% for men (p < 0.0001). OR: 1.36 (CI 1.3; 1.43).
Race: Phase-IV-Analysis: No significantly different HSR incidences for white (0.70%) and Asian (0.61%) patients (p = 0.3094) were detected.
Region/country: Phase-IV-Analysis: The overall world HSR-incidence was 0.62%. Europe: 0.52%, Asia: 0.70%, USA: 0.75%, Germany: 0.51%, China: 0.41%, South Korea: 0.76%.GPV-Analysis: The overall world HSR-reporting rate was 0.015%, varying across regions/countries.
Conclusion: Women showed a slightly higher risk for HSRs than men. Impact of race was not found. HSR-reporting varied by region/country.
Advances in knowledge: Risk for HSRs was increased by female sex but not by race or region/country.
期刊介绍：
BJR is the international research journal of the British Institute of Radiology and is the oldest scientific journal in the field of radiology and related sciences.
Dating back to 1896, BJR’s history is radiology’s history, and the journal has featured some landmark papers such as the first description of Computed Tomography "Computerized transverse axial tomography" by Godfrey Hounsfield in 1973. A valuable historical resource, the complete BJR archive has been digitized from 1896.
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- 2015 Impact Factor – 1.840
- Receipt to first decision – average of 6 weeks
- Acceptance to online publication – average of 3 weeks
- ISSN: 0007-1285
- eISSN: 1748-880X
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