A prospective open-label study evaluating the efficacy and adverse reactions of the use of Niferex-150 in ESRD patients receiving EPOGEN.

Iron supplementation is usually required in patients receiving epoetin alfa. Ferrous sulfate is commonly prescribed, however many patients experience adverse gastrointestinal effects. Adverse effects may limit the amount of iron that can be prescribed, and may lead to noncompliance. Polysaccharide-iron complex (PIC) is an iron supplement containing greater amounts of elemental iron, and may produce fewer adverse effects. This study compared the efficacy and adverse effects of PIC to a historical period of treatment with ferrous iron salts to 38 dialysis patients receiving epoetin alfa. All patients were switched to PIC, and were followed for six months. The following laboratory information was recorded: hematocrit, serum iron concentration, percent transferrin saturation, total iron-binding capacity, serum ferritin concentration. Patients were given an adverse experience questionnaire at four and six months of PIC treatment. No differences in laboratory values were noted between treatments. The amount of prescribed elemental iron increased, while iron dextran use decreased during PIC therapy. Epoetin alfa doses were unchanged. Patients reported fewer gastrointestinal adverse effects at four months, however differences at six months were less striking. PIC is as effective as ferrous sulfate in sustaining erythropoiesis in patients receiving epoetin alfa. It may produce fewer adverse effects.