• Login
    View Item 
    •   RD&E Research Repository Home
    • All RD&E publications by year
    • 2022 Eastern publications
    • View Item
    •   RD&E Research Repository Home
    • All RD&E publications by year
    • 2022 Eastern publications
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Real-world experience of intravenous ferric derisomaltose evaluated through safety and efficacy reporting in the UK

    Thumbnail
    URI
    https://rde.dspace-express.com/handle/11287/622756
    Author
    Sinclair, R. C. F.
    Nadaraja, S.
    Kennedy, N. A.
    Wakatsuki, M.
    Bhandari, S.
    Date
    2022-11-07
    Journal
    Scientific reports
    Type
    Journal Article
    Publisher
    Nature
    DOI
    10.1038/s41598-022-23581-3
    Rights
    © 2022. The Author(s).
    Metadata
    Show full item record
    Abstract
    Ferric derisomaltose (FDI; Monofer) is used in clinical practice to treat iron deficiency, but the safety and efficacy of FDI has not been robustly evaluated in a large real-world study. This retrospective, multicentre, audit-based, observational study provides pragmatic information about safety and clinical responses with FDI across therapy areas and patient populations, helping to facilitate treatment decisions. Participating sites provided data from the medical records of adults who had received ≥ 1 FDI infusion. The primary outcome was the incidence of adverse reactions within 24 hours of the FDI infusion. Secondary outcomes included the change from baseline in haemoglobin and ferritin up to 12 months post infusion. In total, 19 sites provided data for a total of 7354 FDI-treated patients; 64.3% of patients were female, and 42.2% were aged ≥ 70 years. Surgery was the main hospital specialty (34.5%). The incidence of any recorded adverse reactions, hypersensitivity reactions, and anaphylaxis were 1.7%, 0.4%, and < 0.1%, respectively, regardless of baseline anaemia status. Statistically significant increases in haemoglobin and ferritin were observed between baseline and Month 4 following FDI treatment (p < 0.0001). Improvements in haemoglobin were more pronounced for hospital specialties where operative blood loss is expected (surgery/obstetrics) compared with those where blood loss is not expected. This study provides real-world clinical evidence for the low risk of adverse reactions with FDI across diverse patient populations, providing reassurance that intravenous iron is not associated with serious toxicity. These findings may inform changes in intravenous iron delivery to provide effective therapy to more patients in need.
    Citation
    Sci Rep. 2022 Nov 7;12(1):18859. doi: 10.1038/s41598-022-23581-3.
    Note
    This article is freely available online. Click on the 'Additional Link' above to access the full-text via the publisher's site.
    Collections
    • 2022 Eastern publications

    Browse

    All of RD&E Research RepositoryCommunities & CollectionsBy Issue DateAuthorsTitlesSubjectsThis CollectionBy Issue DateAuthorsTitlesSubjects

    My Account

    LoginRegister

    DSpace software copyright © 2002-2023  DuraSpace
    Contact Us | Send Feedback
    DSpace Express is a service operated by 
    Atmire NV