Post-marketing surveillance study with iodixanol in 20185 Chinese patients from routine clinical practices

摘要

Objective: To determine the incidence of immediate and delayed adverse drug reactions (ADRs), and to assess patient discomfort following administration of iodixanol during imaging examinations in routine clinical practice. Methods: Atotal of 20185 patients across 95 clinical centres were enrolled in a prospective post-marketing surveillance registry with iodixanol. Patients were monitored for occurrence of ADRs immediately following iodixanol administration and for up to 7 days after administration. Results: The overall rate of ADRs was 1.52%, of which 0.58%was immediate and 0.97% was delayed onset. Two patients had non-fatal serious ADRs (0.01%). The ADRs were significantly more common in patients who underwent contrast-enhanced CT/coronary CT angiography vs others (p 0.001), in those receiving pre-heated iodixanol vs non-heating (p 0.001), in those aged 70 years or younger (p 0.001), in those in whom a power injector was used for contrast delivery (p 0.001) and in those with a history of an allergic reaction to contrast (p = 0.024). Multivariate analysis showed that female gender, intravenous route of contrast injection, body weight ≥80 kg, age less than 65 years, contrast flow rate ≥4ml s-1 and prior reaction to iodinated contrast medium were all significant and independent contributors to ADRs. Pre-treatment contrast volume and history of cardiac disease, gout, hypertension, diabetes mellitus or asthma did not affect the rate of ADRs. Discomfort was generally mild, with 94.8% of patients reporting a composite score of 0-3. Conclusion: The safety of iodixanol in routine clinical practice was shown to be similar to the published safety profiles of other non-ionic iodinated contrast agents. Patient discomfort during administration was mild or absent in most patients. Advances in knowledge: The major strength of this study is that it included 20185 patients enrolled in various types of imaging examinations. The safety profile of iodixanol was comparable to previously published work.