ArticleThe British journal of radiology2024
Does the risk of hypersensitivity reactions to iopromide differ by sex, race, or across regions/countries? An analysis of 152 233 patients from 4 observational studies and the company's pharmacovigilance database.
Article in The British journal of radiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- Risk factor analysis of iodinated contrast medium-related hypersensitivity reactions.Insights into imaging · 2025Review
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6 authors.
Funding
Abstract
objectiveTo analyse 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.
methodsTwo 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 global pharmacovigilance (GPV)-Analysis was based on HSR case reports in the company database. Exposure estimates were derived from sales/market research data.
resultsThe Phase-IV-Analysis comprised 152 233 patients from 37 countries. In the full-analysis set 145 033, 59 412, and 146 649 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 were available. Sex: Phase-IV-Analysis: The HSR incidence was significantly higher for women (0.72%) vs men (0.55%) (P ≤ .0001). The unadjusted odds ratio (OR) was 1.3 (95% CI, 1.154-1.499), the adjusted OR was 1.156 (95% CI, 1.006-1.328) (P = .04). GPV-Analysis: Reporting rates were 0.0102% for women and 0.0075% for men (P < .0001). OR: 1.36 (95% CI, 1.3-1.43). Race: Phase-IV-Analysis: No significantly different HSR incidences for white (0.70%) and Asian (0.61%) patients (P = .3094) were detected. Region/country: Phase-IV-Analysis: The overall world HSR-incidence was 0.62%. Europe: 0.52%, Asia: 0.70%, United States: 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.
conclusionWomen 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.
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