Role of oral versus IV iron supplementation in the erythropoietic responseto rHuEPO: a randomized, placebo-controlled trial

BACKGROUND: Preoperative treatment with rHuEPO (epoetin alfa: EPREX, Jansse n-Cilag; or PROCRIT, Ortho Biotech) in conjunction with iron supplementatio n increases the erythropoietic response in elective orthopedic surgery pati ents, but it is not known whether the magnitude of this response is depende nt on the route of iron administration. STUDY DESIGN and METHODS: Non-iron-deficient patients undergoing elective o rthopedic surgery (N = 110) with baseline Hb greater than or equal to 10 to less than or equal to 13 g per dL were randomly assigned to receive either epoetin alfa (600 IU/kg) plus IV iron (n = 29) or oral iron (n = 29) or pl acebo plus IV iron (n = 25) or oral iron (n = 27) in this 14-day study. RBC production, Hb, Hct, reticulocytes, iron status, and adverse events were m onitored throughout the study. RESULTS: Epoetin alfa treatment plus either oral or IV iron supplementation significantly increased total RBC production, Hb, Hct, and reticulocytes o ver the values seen with the respective placebo treatments (p = 0.0001). Th ere were no differences between the epoetin alfa treatment groups. Placebo treatment plus oral or IV iron supplementation was not associated with incr eases in hematologic values. There were no differences in the incidence of adverse events among the treatment groups. CONCLUSION: There was a comparable erythropoietic response to epoetin alfa, irrespective of the route of iron administration. The route of iron admini stration, therefore, does not modulate the erythropoietic response to epoet in alfa in patients who are not iron deficient. Safety and convenience bene fits may be gained by adopting oral iron supplementation in this patient su bset.