Efficacy of once-weekly intravenous administration of epoetin-beta as a maintenance treatment for anemia in Japanese hemodialysis patients: a multicenter, open-label clinical study.
Epoetin-beta is extremely useful as a drug for treating anemia in hemodialysis (HD) patients and is widely used for that purpose. The aim of this study was to determine whether once-weekly intravenous administration of epoetin-beta is as effective in maintaining hemoglobin (Hb) concentration as the same weekly dose administered 2 or 3 times per week as maintenance treatment of anemia in HD patients. The subjects were stable HD patients who had been receiving HD for at least 12 months. Using a fixed weekly dose of 3000 or 6000 IU of epoetin-beta, this study evaluated maintenance of improvement of anemia by comparing Hb concentration in the study period (once-weekly) with Hb concentration in the prestudy period (2 or 3 times per week). Of the 112 patients treated with epoetin-beta, 111 patients (full analysis set; 3000 IU, 52 patients; 6000 IU, 59 patients) were evaluated, after excluding one patient whose dose was changed immediately before study initiation. The change in the Hb concentration was maintained within +/-1.5 g/dL in 89.2% of patients (3000 IU, 88.5%; 6000 IU, 89.8%). The mean Hb concentration was 10.42 +/- 0.73 g/dL at study initiation and 10.14 +/- 1.00 g/dL at study completion. Adverse reactions occurred in 9.8% of patients (11 out of 112 patients). The main adverse reactions were malaise and increased blood pressure. Once-weekly intravenous administration of epoetin-beta is useful as maintenance treatment of anemia in HD patients and may be a treatment option.
Shigematsu
Takashi
T
Division of Nephrology and Blood Purification Center, Wakayama Medical University, Wakayama, Japan. taki@wakayama-med.ac.jp
Takami
Hiroya
H
Shimizu
Tatsuo
T
Shimoyama
Hiromi
H
Kim
Songsu
S
Hirose
Satoru
S
Sakai
Takehiko
T
Kono
Takashi
T
Mochizuki
Takahiro
T
Nishio
Kyosuke
K
Degawa
Hisakazu
H
Motomiya
Yoshihiro
Y
D000368:Aged; D000740:Anemia / Q000188:drug therapy*; D001794:Blood Pressure / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006397:Hematinics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins; D006435:Renal Dialysis
D006397:Hematinics; D006454:Hemoglobins; D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin