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Aims: Iron deficiency anaemia (IDA) is common in patients with inflammatory bowel disease (IBD), who are often treated with intravenous iron. This observational study aimed to investigate the effectiveness and safety of iron isomaltoside in routine practical care of IDA in IBD patients. Methods: The study included 197 IBD patients designated for treatment with iron isomaltoside. Treatment was administered according to routine practice. Data were recorded at baseline and after approximately 4, 8, and 16 weeks. Efficacy data included haemoglobin (Hb) levels and haematinics, while safety data included adverse drug reactions and safety laboratory variables. Results: Patients received a mean (range) cumulative dose of 1304 (100-3500) mg iron isomaltoside. Hb increased from 10.7(±1.6) g/dL at baseline to 13.1(±1.5) g/dL at the final visit. In addition, serum iron, ferritin and transferrin saturation increased and soluble transferrin receptor decreased. Calprotectin decreased, as did IBD symptom scores, Harvey-Bradshaw Index (Crohn’s disease) and partial Mayo score (Ulcerative colitis). About 8% of patients reported transient adverse reactions, most commonly skin reactions, nausea and vomiting, and 2% SAEs, most frequently tachycardia. Conclusion: Iron isomaltoside was demonstrated to be effective and had a good safety profile in IBD patients in everyday clinical practice in Germany. [ABSTRACT FROM AUTHOR]

Aims: The aim of this study was to investigate the effectiveness, safety, and tolerability of iron isomaltoside in routine practical care of iron deficiency anemia (IDA) in patients with chronic renal failure., Methods: The study included 698 patients with IDA on dialysis or with nondialysis chronic kidney disease (CKD) stages 3 - 5 designated by their physicians for treatment with iron isomaltoside. Data were recorded at baseline and after 3 and 9 months. Effectiveness data included measurement of hemoglobin (Hb), hematocrit, i-iron, transferrin saturation (TSAT), and i-ferritin. Safety data included adverse events and safety laboratory variables., Results: Following administration of a mean cumulative dose of 2,574 mg isomaltoside over 9 months, initial average Hb increased from 11.0 g/dL to 11.6 g/dL, TSAT from 19.4% to 28.3%, and i-ferritin from 320 µg/L to 642 µg/L, demonstrating a positive effect of iron isomaltoside on iron deficiency. In addition, there was a significant reduction in the use of erythropoiesis-stimulating agents (ESAs) (regarding epoetin α, initial mean dose 40,688 IU/month, final dose 35,665 IU/month, -13.7%, p < 0.001). No drug-related adverse events were reported. Furthermore, safety parameters including i-phosphate indicated no abnormal changes., Conclusions: Iron isomaltoside demonstrated very good effectiveness and tolerability in patients with stage 3 - 5 CKD, including an ESA saving effect.
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