RESUMO
BACKGROUND: In gastroenterological disorders, iron deficiency (ID) is often treated with intravenous iron. This real-world study assessed the effectiveness and safety of iron isomaltoside (IIM), a high-dose intravenous iron, for the treatment of ID in patients with gastroenterological disorders, as part of a service evaluation and improvement process. METHODS: Medical records of 117 patients with gastroenterological disorders, who received IIM, were examined retrospectively. Study outcomes included dose of IIM (estimated iron need versus actual dose received), number of appointments required to deliver the dose and changes in haemoglobin (Hb) and ferritin at ~1 month and ~6 months post-treatment. Safety was assessed through adverse drug reactions (ADRs). RESULTS: Overall, 76.1% of patients received their estimated iron need; 23.9% were underdosed. The mean (SD) iron dose was 1317 (409.7) mg; 62.4% of patients received their dose in one appointment. From baseline, mean (SD) Hb increased by 20.9 (15.4) g/L at 1 month post-treatment (p<0.0001) and by 22.0 (17.9) g/L at 6 months post-treatment (p<0.0001). Mean (SD) baseline ferritin was 26.6 (37.8) µg/L, which increased to 234.6 (142.9) µg/L at 1 month post-treatment (p<0.0001), and remained increased at 6 months post-treatment (122.8 (99.2) µg/L; p<0.0001). A substantial proportion of patients were non-anaemic at 1 month (57.5%) and 6 months (61.8%) post-treatment. At both post-treatment timepoints, the proportion of non-anaemic patients was higher in those receiving their total iron need versus those who were underdosed. No serious ADRs were reported. CONCLUSION: IIM was efficacious and well tolerated in patients with gastroenterological disorders. This real-world study highlights the importance of administering the full iron need to maximise treatment response.