Role of oral versus IV iron supplementation in the erythropoietic response to rHuEPO: a randomized, placebo-controlled trial.
BACKGROUND
Preoperative treatment with rHuEPO (epoetin alfa: EPREX, Janssen-Cilag; or PROCRIT, Ortho Biotech) in conjunction with iron supplementation increases the erythropoietic response in elective orthopedic surgery patients, but it is not known whether the magnitude of this response is dependent on the route of iron administration.


METHODS
Non-iron-deficient patients undergoing elective orthopedic surgery (N = 110) with baseline Hb > or =10 to < or =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 placebo 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 monitored throughout the study.


RESULTS
Epoetin alfa treatment plus either oral or IV iron supplementation significantly increased total RBC production, Hb, Hct, and reticulocytes over the values seen with the respective placebo treatments (p = 0.0001). There were no differences between the epoetin alfa treatment groups. Placebo treatment plus oral or IV iron supplementation was not associated with increases in hematologic values. There were no differences in the incidence of adverse events among the treatment groups.


CONCLUSIONS
There was a comparable erythropoietic response to epoetin alfa, irrespective of the route of iron administration. The route of iron administration, therefore, does not modulate the erythropoietic response to epoetin alfa in patients who are not iron deficient. Safety and convenience benefits may be gained by adopting oral iron supplementation in this patient subset.
Olijhoek
G
G
Velp Hospital, Kennedylaan 100, Velp 6883 AZ, the Netherlands. golyhoek@hotmail.co
Megens
J G
JG
Musto
P
P
Nogarin
L
L
Gassmann-Mayer
C
C
Vercammen
E
E
Hayes-Licitra
S A
SA
D000284:Administration, Oral; D000368:Aged; D019587:Dietary Supplements; D000068817:Epoetin Alfa; D004920:Erythropoiesis / Q000187:drug effects*; D004921:Erythropoietin / Q000494:pharmacology*; D005260:Female; D005293:Ferritins / Q000097:blood; D006801:Humans; D007275:Injections, Intravenous; D007501:Iron / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000494:pharmacology; D020250:Postoperative Nausea and Vomiting / Q000139:chemically induced; D011994:Recombinant Proteins
D010919:Placebos; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa; D005293:Ferritins; D007501:Iron