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

Korean Journal of Nephrology 2009;28(5):450-455.

Ji Young Lee, M.D., Seung Woon Byun, M.D., Young Sun Yeo, M.D., Won Seok Yang, M.D., Su-Kil Park, M.D., Jung Sik Park, M.D. and Jai Won Chang, M.D.

Department of Internal Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea

임상연구 : 혈액 투석 환자에서 epoetin alfa와 darbepoetin alfa의 조혈 효과 비교: 무작위 교차 연구

이지영, 변승운, 여영선, 양원석, 박수길, 박정식, 장재원

울산대학교 의과대학 서울아산병원 내과학교실

Abstract

Purpose:We aim to compare the erythropoietic effects of epoetin-α (EA, 4000 IU SC thrice a week) with those of darbepoetin-α (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 ≤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 ≤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 ≤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.

Key Words: Epoetin alfa, Darbepoetin alfa, Hemodialysis, Anemia