Abstract
Aims: Iron deficiency is common in patients with chronic kidney disease (CKD). Appropriate iron substitution is critical and intravenous iron is an established therapy for these patients. The objective of this study was to assess treatment routine, effectiveness, and safety of iron isomaltoside (Monofer®, Pharmacosmos A/S, Holbaek, Denmark) in CKD patients in clinical practice. Materials and methods: This was a prospective observational study conducted in predialysis CKD patients treated with iron isomaltoside according to the product label and to routine clinical care. Results: The study included 108 patients with predialysis CKD: 22 were in stage 2 – 3, 41 in stage 4, and 45 in stage 5. The mean (standard deviation) age was 67 (15) years, and 55% of patients were male. The majority of patients (65%) received one iron isomaltoside treatment. In patients with a baseline Hb < 10 g/dL, the mean dose of iron isomaltoside in the study was lower than the estimated total iron requirement (567 mg versus 921 mg). A treatment response of Hb ≥ 1 g/dL was achieved in 16/28 (57%) of patients, and the mean post-treatment Hb level was 10.5 g/dL. The probability of retreatment did not correlate with dose, but no dose administered was > 1,000 mg. There were no serious adverse drug reactions. One nonserious adverse drug reaction – injection site discoloration – was reported, and the patient had an uneventful recovery. Conclusion: Iron isomaltoside shows a good effectiveness and safety profile in predialysis CKD patients. However, some patients did not receive adequate iron doses to allow for optimal correction of their iron deficiency anemia.
Highlights
Iron deficiency anemia (IDA) is commonly associated with chronic diseases, such as chronic kidney disease (CKD) [1]
The probability of needing retreatment with iron isomaltoside over time was analyzed using a Cox proportional hazards model, with dose category and diagnosis group as factors, and baseline Hb as covariate. p-values were obtained from a two-sided Wald test comparing the hazard ratios (HRs) with one
For the pre- to post-treatment changes in blood parameters, mean change estimates were obtained from an analysis of covariance model with dose category and diagnosis group as factors, and pretreatment value as covariate. p-values for blood parameters were obtained from a two-tailed probability of comparing the mean changes to null
Summary
Iron deficiency anemia (IDA) is commonly associated with chronic diseases, such as chronic kidney disease (CKD) [1]. Patients with CKD may become iron deficient for various reasons including: blood loss during dialysis, use of erythropoiesisstimulating agents (ESAs), and chronic inflammation where enhanced hepcidin levels block the intestinal absorption of iron and its release from iron stores [2, 3, 4]. Iron supplementation plays a major role in the management of anemia in CKD patients [9]. In predialysis CKD patients, the use of intravenous (IV) iron is recommended as it is more effective than oral iron to replace the iron stores, and the risk of gastrointestinal side-effects is lower [12]
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