دورية أكاديمية
DOP89 Effects of ferric derisomaltose and ferric carboxymaltose on hypophosphatemia in iron-deficiency anaemia due to Inflammatory Bowel Disease: A Phase IV randomised clinical trial
| العنوان: | DOP89 Effects of ferric derisomaltose and ferric carboxymaltose on hypophosphatemia in iron-deficiency anaemia due to Inflammatory Bowel Disease: A Phase IV randomised clinical trial |
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| المؤلفون: | Zoller, H, Wolf, M, Blumenstein, I, Primas, C, Lindgren, S, Thomsen, L L, Reinisch, W, Iqbal, T |
| المصدر: | Journal of Crohn's and Colitis ; volume 15, issue Supplement_1, page S121-S121 ; ISSN 1873-9946 1876-4479 |
| بيانات النشر: | Oxford University Press (OUP) |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Gastroenterology, General Medicine |
| الوصف: | Background Intravenous iron can correct iron deficiency anaemia (IDA) in inflammatory bowel disease (IBD). Certain formulations are associated with hypophosphatemia, but this has not previously been investigated in a randomised clinical trial in IBD. The aim of this randomised, double-blind trial was to compare the risk of hypophosphatemia with ferric derisomaltose/iron isomaltoside 1000 (FDI) vs ferric carboxymaltose (FCM) in patients with IDA due to IBD. Methods Adults with IBD and IDA (haemoglobin [Hb] <13g/dL; s-ferritin ≤100ng/mL) who were unsuitable for oral iron treatment were recruited at outpatient clinics in 5 European countries. Patients were randomised 1:1 to FDI or FCM (1000mg at baseline and 500 or 1000mg at Week 5 based on weight and iron need at baseline). The primary endpoint was the incidence of hypophosphatemia (s-phosphate <2.0mg/dL) from baseline to Week 5. Additional endpoints included biomarkers of bone and mineral metabolism, Hb concentrations, fatigue score, and adverse events (AEs). Results Of 97 patients enrolled (mean age 42.1 years; 52.6% female; 39.2% Crohn’s disease; 60.8% ulcerative colitis), 48 received FDI and 49 FCM. The incidence of hypophosphatemia was significantly lower for FDI than FCM (8.3% vs. 51.0%; p<0.0001). After the first dose, biomarker responses (least squares mean change from baseline) were significantly less pronounced after FDI than FCM: s-phosphate decreased less with FDI than FCM, with a nadir at Week 1 (FDI, -0.49mg/dL; FCM, -1.33mg/dL; p<0.0001); urinary fractional excretion of phosphate increased less at Week 1 (FDI, 2.58%; FCM, 9.22%; p=0.0021); intact fibroblast growth factor 23 increased markedly over the first day only with FCM (FDI, -8.54pg/mL; FCM, 149.31pg/mL; p<0.0001); 1,25-dihydroxyvitamin D decreased less with FDI than FCM, with a nadir at Week 1 (FDI, -16.39pg/mL; FCM, -30.83pg/mL; p<0.0001); parathyroid hormone increased only in the FCM group, with a peak at Week 2 (FDI, -2.22pg/mL; FCM, ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1093/ecco-jcc/jjab073.128 |
| الإتاحة: | https://doi.org/10.1093/ecco-jcc/jjab073.128Test http://academic.oup.com/ecco-jcc/article-pdf/15/Supplement_1/S121/38317186/jjab073.128.pdfTest |
| حقوق: | https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_modelTest |
| رقم الانضمام: | edsbas.AC2DED |
| قاعدة البيانات: | BASE |
| DOI: | 10.1093/ecco-jcc/jjab073.128 |
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