Comparison of Erythropoietic Effect between Epoetin-alpha and Darbepoetin-alpha in Hemodialysis Patients: A Randomized Crossover Study

Lee, Ji Young; Byun, Seung Woon; Yeo, Young Sun; Yang, Won Seok; Park, Su Kil; Park, Jung Sik; Chang, Jai Won

Abstract

PURPOSE
We aim to compare the erythropoietic effects of epoetin-alpha (EA, 4000 IU SC thrice a week) with those of darbepoetin-alpha (DA, 60ug IV weekly, conversion rate to EA=200:1).
METHODS
Forty one stable hemodialysis patients were enrolled in this randomized crossover study. After a washout period of erythropoietin stimulating agents (ESA), the patients with hemoglobin (Hb) level of < or =11.0 g/dL were randomly assigned to DA or EA and we measured Hb and reticulocyte levels. When Hb reached >11.0 g/dL, we stopped ESA. When Hb level decreased to < or =11.0 g/dL again, we switched to alternative ESA and repeated the rest of the steps.
RESULTS
Thirty six patients (M:F=20:16, age 62+/-11 years, Kt/V 1.65, nPCR 1.13 g/kg/day) completed the study. No significant differences were observed in baseline parameters between DA and EA during the period of the clinical trial. The rate of Hb level increase (EA 0.29 g/dL/week, DA 0.30 g/dL/week, p=0.76) and decrease (EA 0.45 g/dL/week, DA 0.38 g/dL/week, p=0.14) were not different between two periods. After ESA stopped, the duration of decreased Hb level of < or =11.0 g/dL was not significantly different (4 weeks in EA vs. 3.9 weeks in DA, p=0.86). Erythropoietin resistance index was 10.59 in the EA period. It was not significantly different from 10.97 in DA period (p=0.49). Nine patients (25%) showed a >30% change in EA efficiency relative to DA efficiency.
CONCLUSION
There was no significant difference in erythropoietic parameters for both EA and DA.