Nephrotoxicity of low-osmolar and iso-osmolar iodinated contrast media
-- a pharmacovigilance study based on real-world database
Abstract
Abstract Aim: We aim to compare nephrotoxic spectrum of IOCM and that of
LOCM in a more intensive and comprehensive perspective using the
real-world database. Methos: This is an observational, retrospective,
pharmacovigilance study based on Vigibase. 7 products (iodixanol,
iohexol, iopamidol, iopromide, iobitridol, ioversol and iomeprol) of ICM
were included. Variable matching method was used for deduplication
procedure. Two data mining method, reporting odds ratio (ROR) and
bayesian confidence propagation neural networks of information
components (IC) were used to detect signals for the full database,
gender stratums (male and female), age stratum (0 to 64 years, 65 to 74
years and 75 or more years) and pooled analysis of total renal adverse
events (AEs). Package ‘base’, ‘utils’ and ‘pheatmap’ of R language
(version 4.1.2) were used to perform analysis and plot figures. Results:
We got 2703 ICSRs and 3155 renal AE reports. The five most frequently
reported were acute kidney injury, renal failure, renal impairment
azotaemia and anuria. All ICM had highest signal value detected in age
≥75 years. Iodaxinal and iohexol had most signals detected. In pooled
analysis of renal AEs, no signals detected for iopamidol, iomeprol and
iopromide in the full database stratum. Conclusion: No evidence approved
IOCM has safer nephrotoxicity than LOCM. CIN spectrum varies a lot
within LOCM. Regarding to the whole population, not all products of ICM,
such as iopamidol, iomeprol and iopromide, is likely to cause CIN.