Abstract

Abstract Background and Aims In 2013, the European Medicines Agency (EMA) claimed that iron preparations should be exclusively given in an environment where resuscitation facilities are available and, therefore, the iron administration was highly discouraged without the presence of a doctor. What this means is that in dialysis centres without regular medical presence the dose of iron administered might be inadequate. Ferric carboxyimaltose (FCM) allows to administer high single doses of iron with an excellent safety profile. Method We compare the effect of a maintenance iron therapy in two groups of prevalent and clinical stable hemodialysis patients; the former (A; n=19pts) was treated with iron gluconate (FG) in low refracted doses (i.e. 60 mg one or two times a week) while the latter (B;n=20 pts) was treated with FCM in high doses (i.e. 200 mg once or twice a month). The groups have been followed up for one year. All treated patients in the two groups had similar and “adequate” basal iron parameters according to European Clinical Guideline (Serum Ferritin(SF) ≥200 mic/l and transferrin saturation(TS) ≥20%) (see Table 1). The therapy was administered in order to maintain SF between 200-500 mic/l and TS between 20-40%. Erythropoietin dose (Epo) was evaluated considering the erythropoietin resistance index (ERI =EPO/weight/Hb). Results Table 1 show the results at the start and end follow up. The mean monthly iron dose was similar between the two groups at the end of follow up (144±100 mg group A vs 157±81 mg group B). In group A there was a more significant increase in the TS with a non-significant trend to an increase in SF. Six pts of group A had an overshooting of SF (1164±360mc/L) vs 3 pts in group B (SF 830±30 mc/L). No significant differences in pre and post therapy ERI could be recorded. Conclusion A therapy with a high single doses of FCM could be a positive solution to treat patients in dialysis centres without regular medical presence.

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