Safety and tolerability of iopromide intravascular use: a pooled analysis of three non-interventional studies in 132,012 patients

Abstract

Background Determining the safety of contrast agents is challenging. In the absence of large controlled clinical trials, non-interventional (post-marketing surveillance) studies provide an opportunity to clearly investigate the safety profile of contrast agents. Purpose To assess the safety profile of iopromide in contrast-enhanced X-ray in clinical practice, using pooled data from three non-interventional studies. Material and Methods All studies were international, multicenter, non-interventional studies examining iopromide tolerability in clinical practice. Patients received iopromide (iodine concentrations of 300 mg/mL or 370 mg/mL) via intravenous or intra-arterial administration according to the diagnostic indication and in compliance with the local package insert. Results In total, 132,012 patients (37 countries, >1600 centers) were included. Overall, 3823 patients (2.49%) reported an adverse drug reaction (ADR) and 1983 patients (1.50%) reported an ADR without tolerance indicators (injection site warmth, feeling hot or injection site pain, of mild intensity only). This is a similar rate to other low osmolar contrast media. In most patients, ADRs were mild ( n = 2632; 1.99% of all patients) and did not require any action ( n = 2799; 2.12% of all patients). ADRs were more common among women ( n = 1680 [2.8%]) than men ( n = 1586 [2.2%]) and among younger patients (<18 years: n = 98 [3.2%]) than older patients (18–49 years: n = 1261 [3.5%]; 50–69 years: n = 1224 [2.2%]; ≥70 years: n = 362 [1.5%]). The most common ADRs were injection site warmth/feeling hot, nausea/vomiting, and dysguesia. Forty-five serious ADRs were reported in 19 patients. ADRs were more common in at-risk patients (5.00%) than in the overall population. Conclusion This pooled analysis confirms the well-established good safety profile of iopromide in clinical practice in Asian and European countries and the USA.