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GW24-e0997 Postmarketing Surveillance Study with Iodixanol in 20185 Chinese Patients from Routine Clinical Practices

Objectives To determine prospectively the incidence and nature of immediate and delayed ADRs occurring after administration of iodixanol in routine clinical practices among non-selected patients, and to assess patient discomfort (pain and sensations of heat or coldness). Methods A total of 20,185 patients were enrolled in a prospective postmarketing surveillance registry with iodixanol. A standardized questionnaire was used to collect the following patient information from 95 centres in the mainland of China: baseline demographics, risk factors, type of examination, route of injection, volume and selected concentration of iodixanol, and overall tolerance to iodixanol (utilizing specific criteria and descriptors). Results The overall rate of ADRs was 1.52%, of which 0.58% was immediate, and 0.97% was delayed onset. Two cases had serious ADRs (rate 0.01%),of which none were fatal. The incidence of ADRs was significantly higher in the following groups:(1) patients with “poor” punctured vein status, (2) patients receiving pre-heated iodixanol, (3) patients underwent coronary CT angiography or contrast-enhanced CT, (4) patients receiving intravenous iodixanol compared with those intraarterial injection, (5) patients aged 65 years or less compared with those aged 66 years or over, (6) those with a past history of adverse reactions to contrast media, (7) patients with automatically high pressure injectors than those with manually injectors, and (8) patients without hypertension than those with hypertension. Discomfort was generally mild, with 94.8% of patients reporting a composite score of 0 – 3. Conclusions The safety of iodixanol in routine clinical practice was shown to be comparable to the published safety profiles of other nonionic iodinated contrast agents. ADRs rate was affected by age, examination type, contrast medium temperature, status of vein, administration route, and risk factors. Patient discomfort during administration was mild or absent in most patients.