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.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1177/0284185113504753 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
COLOFIT: Development and Internal-External Validation of Models Using Age, Sex, Faecal Immunochemical and Blood Tests to Optimise Diagnosis of Colorectal Cancer in Symptomatic Patients.
Aliment Pharmacol Ther
January 2025
Gastrointestinal and Liver Theme, National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre (BRC), Nottingham University Hospitals NHS Trust and the University of Nottingham, School of Medicine, Queen's Medical Centre, Nottingham, UK.
Background: Colorectal cancer (CRC) is the third most common cancer in the United Kingdom and the second largest cause of cancer death.
Aim: To develop and validate a model using available information at the time of faecal immunochemical testing (FIT) in primary care to improve selection of symptomatic patients for CRC investigations.
Methods: We included all adults (≥ 18 years) referred to Nottingham University Hospitals NHS Trust between 2018 and 2022 with symptoms of suspected CRC who had a FIT.
Diagnostic and Management Challenges in Interferon-γ Release Assay-Positive Patient with Sarcoid Panuveitis from a Non-Endemic Tuberculosis Region.
Ocul Immunol Inflamm
January 2025
Eye Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates.
Purpose: To report a case of biopsy-proven sarcoidosis in a patient with panuveitis and a positive interferon-gamma release assay (IGRA) from a non-endemic tuberculosis (TB) country.
Methods: Case report.
Results: A 26-year-old male from the United Arab Emirates (UAE) presented with granulomatous panuveitis characterized by mutton-fat keratic precipitates, anterior chamber and vitreous cells, and retinal vasculitis.
Incidence of fall-from-height injuries and predictive factors for severity.
J Osteopath Med
January 2025
McAllen Department of Trauma, South Texas Health System, McAllen, TX, USA.
Context: The injuries caused by falls-from-height (FFH) are a significant public health concern. FFH is one of the most common causes of polytrauma. The injuries persist to be significant adverse events and a challenge regarding injury severity assessment to identify patients at high risk upon admission.
View Article and Find Full Text PDFApplication of midnight-noon ebb-flow combined with five-element music therapy in continuous nursing of patients with chronic wounds.
J Eval Clin Pract
February 2025
Ordos Hospital of Traditional Chinese Medicine, Ordos City, China.
Background: To investigate the effect of Midnight-noon Ebb-flow combined with five-element music therapy in the continuous nursing of patients with chronic wounds.
Methods: From March 2022 to November 2023, we recruited 50 eligible chronic wound patients and randomly divided them into two groups according to a random number table: the experimental group (n = 25) and the control group (n = 25). The control group was treated with conventional nursing measures.
The assessment of point-of-care ultrasound (POCUS) in residency: the benefits of a four-year longitudinally integrated curriculum.
J Osteopath Med
January 2025
Arizona College of Osteopathic Medicine, Midwestern University, Glendale, AZ, USA.
Context: Point-of-care ultrasound (POCUS) has diverse applications across various clinical specialties, serving as an adjunct to clinical findings and as a tool for increasing the quality of patient care. Owing to its multifunctionality, a growing number of medical schools are increasingly incorporating POCUS training into their curriculum, some offering hands-on training during the first 2 years of didactics and others utilizing a longitudinal exposure model integrated into all 4 years of medical school education. Midwestern University Arizona College of Osteopathic Medicine (MWU-AZCOM) adopted a 4-year longitudinal approach to include POCUS education in 2017.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!