Safety and diagnostic image quality of iopromide: results of a large non-interventional observational study of European and Asian patients (IMAGE).

Background: Iodine-based contrast agents such as iopromide play a central role in improving the diagnostic quality of imaging modalities using ionizing radiation.

Purpose: To investigate the safety and diagnostic image quality of iopromide in the routine clinical setting.

Material And Methods: This was an international, multicenter, prospective, single-arm, non-interventional study (NIS). The study was performed in out- and inpatients in 738 study centers in 21 countries in Europe and Asia. Iopromide was administered in a routine manner, in compliance with the local package insert. The use of premedication was at the discretion of the attending physician. Case report forms for 44,835 patients were analyzed (57.4% men). The median age of the patients was 55 years.

Results: For the vast majority of patients (94.8%), the contrast quality was rated as 'good' (55.8%) or 'excellent' (39.0%). For 1265 (2.8%) patients, there were reports of adverse drug reactions (ADRs) excluding tolerance indicators (TIs) (i.e. injection site warmth, feeling hot, or injection site pain of mild intensity). At least one ADR including TIs was reported in 2415 (5.4%) patients. There were 11 (0.02%) patients with serious ADRs, and no drug-related deaths. Events of injection site warmth and/or feeling hot were reported by 3.5%, nausea and/or vomiting by 0.96%, and urticaria, erythema, and/or rash by 0.54% of patients. Patients at risk for an acute idiosyncratic reaction (i.e. patients with a history of bronchial asthma, allergies, and/or contrast media reaction) had a higher incidence of ADRs compared with the overall study population. At-risk patients who did not receive premedication reported distinctly more ADRs compared with those who received premedication (12.0% versus 5.9%).

Conclusion: Iopromide was shown to be a well-tolerated contrast agent whose usage resulted in high image quality. No unknown ADRs were observed. Premedication with antiallergy drugs should be considered in at-risk patients.