title: 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.
  
  
  OBJECTIVE
  To assess the safety profile of iopromide in contrast-enhanced X-ray in clinical practice, using pooled data from three non-interventional studies.
  
  
  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.
  
  
  CONCLUSIONS
  This pooled analysis confirms the well-established good safety profile of iopromide in clinical practice in Asian and European countries and the USA.
authors.affiliation: Global Medical and Clinical Affairs Radiology, Bayer HealthCare, Berlin, Germany petra.palkowitsch@bayer.com.
authors.forename: Petra K
authors.initials: PK
authors.lastname: Palkowitsch
authors.affiliation: PAREXEL GmbH, Berlin, Germany.
authors.forename: Sven
authors.initials: S
authors.lastname: Bostelmann
authors.affiliation: Global Medical and Clinical Affairs Radiology, Bayer HealthCare, Berlin, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Lengsfeld
mesh_terms: D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D000368:Aged; D001208:Asia; D003287:Contrast Media / Q000008:administration & dosage* / Q000009:adverse effects*; D004408:Dysgeusia / Q000139:chemically induced; D005060:Europe; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D007472:Iohexol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D017678:Sex Distribution; D012871:Skin Diseases / Q000139:chemically induced; D014481:United States; D014839:Vomiting / Q000139:chemically induced; D055815:Young Adult
chemical_list: D003287:Contrast Media; D007472:Iohexol; C038192:iopromide
keywords: Computed tomography; intravascular administration; iopromide; non-interventional study; pooled analysis