Petra K Palkowitsch 1 , Sven Bostelmann 2 , Philipp Lengsfeld 3 Show Affiliations »
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. © The Foundation Acta Radiologica 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.
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. © The Foundation Acta Radiologica 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.
Entities: Chemical
Disease
Species
Keywords:
Computed tomography; intravascular administration; iopromide; non-interventional study; pooled analysis
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Year: 2013
PMID： 24043880 DOI： 10.1177/0284185113504753
Source DB: PubMed Journal: Acta Radiol ISSN： 0284-1851 Impact factor: 1.990