Efficacy and safety of Ferric caboxymaltose in treatment of anaemia

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P170
EFFICACY AND SAFETY OF A SINGLE DOSE OF FERRIC CARBOXYMALTOSE IN TREATMENT
OF IRON DEFICIENCY ANAEMIA IN PATIENTS NOT ON DIALYSIS WITH CHRONIC KIDNEY
DISEASE
McDaid D, Yousif I, Duncan G, Mutwali A, Stack AG
Regional Kidney Centre, Letterkenny, Ireland
PROBLEM: Iron deficiency is an important contributor to anaemia of chronic kidney disease. Intravenous iron
therapy is commonly used in treatment but there is considerable variability in the efficacy, safety and cost
effectiveness of many commonly available iron preparations.
Ferric Carboxymaltose is a relatively new preparation available on the market with possibly fewer side effects,
similar efficacy and with potentially greater cost savings.
PURPOSE: To evaluate the efficacy and safety of Ferric Carboxymaltose in the treatment of iron deficiency
anaemia in patients with moderate to severe chronic kidney disease (CKD).
DESIGN: A prospective observational study of 50 patients with CKD (Stages 3-5) attending the Regional
Kidney Centre from Sept 2008 to Sept 2009. Patients were recruited if they were anaemic (Hb<11.0 g/dl) and had
serum Ferritin levels < 100ng/ml and/or transferrin saturation levels < 20%. Anaemia management was per the
National Kidney Foundation KDOQI guidelines (2006). Treatment consisted of a single dose of intravenous
Ferric Carboxymaltose (15mg/Kg, Max dose 1g) given over 1 hour with additional 30 minutes of nursing
supervision. Patients were monitored for immediate and delayed complications. The study was approved by the
Ethics Committee of the Hospital.
FINDINGS: The average age of participants was 72 years, 52% were male and the mean glomerular filtration
rate was 25.3 ml/min per 1.73m². Twenty eight patients were receiving erythropoietin stimulating agents (ESA).
The following table describes the pre and post treatment response to IV therapy. Treatment with Ferric
Carboxymaltose resulted in significantly improved iron stores and functional iron reserves at 1 month and 3
months post infusion among patients with moderate to severe kidney disease. Total estimated cost savings were
€46 per treated patient when compared with a historical cohort treated with an alternate IV iron preparation given
over 5 weeks.
Haemoglobin (g/dl)*
Ferritin (ng/ml)*
Transferrin Saturation %*
Pre-Treatment
Post Treatment
1 Month
Post Treatment
3 Months
9.9
166
16.1
11.2
517
28.2
11.5
348
27.5
*P<0.05 vs post treatment values
CONCLUSION: Ferric Carboxymaltose is safe and effective in the treatment of iron deficiency anaemia in
patients not on dialysis with CKD. The drug was well tolerated with no reported side effects.
RELEVANCE: The introduction of a single dose Ferric Carboxymaltose has been very convenient for patients.
Additional benefits have been the considerable reduction in staff workload, patient waiting times, with reduced
consumable and transport costs.
References
National Kidney Foundation. KDOQI Clinical Practice Guidelines and Clinical Practice
Recommendations for Anaemia in Chronic Kidney Disease. Am J Kidney Dis (2006) 47([Suppl. 3]):S1- S145.
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