Comparative Prospective Study of Intravenously and Subcutaneously Administered Recombinant Human Erythropoietin(Epokine(R)) in End-Stage Renal Disease Patients : A Phase IV Single Center Study

Song, Hyun Yong; Yoon, Hyang Suk; Kang, Shin Wook; Choi, Kyu Hun; Ha, Sung Kyu; Lee, Ho Yung; Han, Dae Suk

Abstract

BACKGROUND: We evaluated the clinical efficacy and safety of recombinant human erythropoietin(Epokine(R)).
METHODS
A comparative prospective study of intravenously and subcutaneously administrated Epokine(R) conducted 13 patients performing hemodialysis and 28 patients performing continuous ambulatory peritoneal dialysis with end-stage renal disease. Epokine(R) was given initially at a dosage of 100 unit/kg, subcutaneously, two times a week. The patients had achieved stable or more than 10 g/dL of hemoglobin level for 12 weeks and then we randomized switching intravenously or subcutaneously administrated Epokine(R) for another 12 weeks.
RESULTS
Hemoglobin(g/dL) and hematocrit(%) increased significantly from baseline levels beginning from 2 weeks after Epokine(R) administration. In HD patients, hemoglobin increased significantly from 7.3 to 9.5 after 12 weeks and to 10.6 after 24 weeks. In CAPD patients, hemoglobin increased significantly from 6.8 to 10.2 after 12 weeks and then 10.8 after 24 weeks(p < 0.05). Corrected reticulocyte count(%) was significantly increased from baseline levels beginning from 1 week after Epokine(R) administration and continuously increased during study period in both group. Serum ferritin and serum iron decreased significantly and total iron binding capacity increased significantly after 2 weeks. At 12 weeks, HD patients were significantly needed more dosage of Epokine(R) than CAPD patients(142.2+/-20.5 vs 117.3+/-33.6 U/kg/wk, p < 0.001), but at 24 weeks, the dosage was not different(123.6+/-41.5 vs 99.2+/-49.3 U/kg/wk, p > 0.05). In HD patients, intravenously administrated Epokine(R) group was more dosage than subcutaneously group(97.4+/-15.4 vs 145.4+/-2.9 U/kg/wk, p < 0.002), but CAPD patients were not different by administration method(93.0+/-60.2 vs 105.4+/-9.7 U/kg/ wk, p > 0.05). The 9 cases(18.8%) were suffered from headache and flu-like syndrome, but these side effects were not severe and disappeared from conventional therapy.
CONCLUSION
Epokine(R) administration is safe and effective in treating anemia of ESRD patients and subcutaneously administration is significantly more effective than intravenously.