Iobitridol 658mg/ml (Iodine 300mg/ml) infusion 150ml bags

AbstractObjectivesTo demonstrate non-inferiority of iobitridol 350 for coronary CT angiography (CTA) compared to higher iodine content contrast media regarding rate of patients evaluable for the presence of coronary artery stenoses.MethodsIn this multicentre trial, 452 patients were randomized to receive iobitridol 350, iopromide 370 or iomeprol 400 and underwent coronary CTA using CT systems with 64-detector rows or more. Two core lab readers assessed 18 coronary segments per patient regarding image quality (score 0 = non diagnostic to 4 = excellent quality), vascular attenuation, signal and contrast to noise ratio (SNR, CNR). Patients were considered evaluable if no segment had a score of 0.ResultsPer-patient, the rate of fully evaluable CT scans was 92.1, 95.4 and 94.6 % for iobitridol, iopromide and iomeprol, respectively. Non-inferiority of iobitridol over the best comparator was demonstrated with a 95 % CI of the difference of [-8.8 to 2.1], with a pre-specified non-inferiority margin of -10 %. Although average attenuation increased with higher iodine concentrations, average SNR and CNR did not differ between groups.ConclusionsWith current CT technology, iobitridol 350 mg iodine/ml is not inferior to contrast media with higher iodine concentrations in terms of image quality for coronary stenosis assessment.Key Points• Iodine concentration is an important parameter for image quality in coronary CTA. • Contrast enhancement must be balanced against the amount of iodine injected. • Iobitridol 350 is non-inferior compared to CM with higher iodine concentrations. • Higher attenuation with higher iodine concentrations, but no SNR or CNR differences.

Abstract licence: CC BY 4.0

BackgroundAdverse drug reactions to iodinated contrast media (ICM) have risen due to their increasing use in x-ray-based imaging modalities. Delayed hypersensitivity reactions are mainly caused by nonionic monomeric compounds and represent an issue impacting the diagnostic-therapeutic pathways of cancer, cardiology and surgery patients.ObjectivesTo prospectively evaluate the usefulness of skin tests in delayed hypersensitivity reactions to ICM and to evaluate the tolerability of iobitridol, a monomeric nonionic low osmolality compound, as a possible safe alternative.MethodsPatients with delayed hypersensitivity reactions to ICM referred to us from 2020 to 2022 were prospectively enrolled in the study. All patients underwent patch test and, if negative, intradermal test with the culprit ICM and iobitridol as alternative.ResultsA total of 37 patients (females 24, 64.9%) were enrolled in the study. Iodixanol and iomeprol were the most frequently involved ICM (48.5% and 35.2%, respectively); 62.2% of patients presented maculopapular eruption, while 37.8% reported delayed urticaria-like rash. Skin tests resulted positive to the culprit ICM in 19 patients (51.4%), 16 to patch test and 3 to intradermal test. Skin tests with iobitridol, tested as alternative, resulted positive in 3/19 patients (15.8%). All 16 patients with negative results to iobitridol were administered this ICM and tolerated it.ConclusionsIn at least half of patients, delayed-type hypersensitivity was demonstrated by skin tests, particularly by patch test. This diagnostic approach resulted simple, cost-effective and safe, not only to confirm the culprit ICM but also to identify iobitridol as feasible alternative.

Abstract licence: CC BY-NC-ND

We aimed to report the incidence and severity of nonionic low-osmolar iodine contrast medium (ICM)-related adverse drug reactions (ADRs) in the Republic of Korea, by analyzing data from our single tertiary institution and published Korean reports, and to determine whether there is a difference in the incidence of ICM-related ADR by ICM generics. A total of 1,161,419 consecutive contrast-enhanced computed tomography (CT) examinations between January 2016 and December 2021 at Asan Medical Center were included. A systematic search of the literature investigating the incidence of ICM-related ADR in the Republic of Korea published up to December 31, 2021 was performed. We pooled these outcomes with those of our study using a binomial-normal model, and the pooled incidences of ADRs were compared among ICM generics using chi-square tests. Seven studies with a total of 2,570,986 contrast-enhanced CT examinations from 12 institutions were included. The pooled incidences of overall, mild, moderate, and severe ICM-related ADRs in the Republic of Korea were 0.82% (95% CI: 0.61%-1.10%), 0.72% (95% CI: 0.50%-1.04%), 0.11% (95% CI: 0.08%-0.15%), and 0.013% (95% CI: 0.010%-0.018%), respectively. In multiple pairwise comparisons, there were no significant differences in the overall incidence of ADRs between ICM generics, except iomeprol versus iobitridol and iomeprol versus iohexol. For moderate and severe ADRs, there were no significant differences in ADR incidence between ICM generics. The incidence of moderate and severe ICM-related ADRs did not differ among ICM generics. Our results suggest that no restriction is required for selection among nonionic low-osmolar ICMs.

Abstract licence: CC BY