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.

Abstract

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. 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. 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. 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). Phase-IV-Analysis: No significantly different HSR incidences for white (0.70%) and Asian (0.61%) patients (p = 0.3094) were detected. 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. Women showed a slightly higher risk for HSRs than men. Impact of race was not found. HSR-reporting varied by region/country. Risk for HSRs was increased by female sex but not by race or region/country.