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.

Objective: To 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.
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 global pharmacovigilance (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, 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.
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.
(© The Author(s) 2024. Published by Oxford University Press on behalf of the British Institute of Radiology.)