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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.

Abstract
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.
AuthorsTakashi Shigematsu, Hiroya Takami, Tatsuo Shimizu, Hiromi Shimoyama, Songsu Kim, Satoru Hirose, Takehiko Sakai, Takashi Kono, Takahiro Mochizuki, Kyosuke Nishio, Hisakazu Degawa, Yoshihiro Motomiya
JournalTherapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy (Ther Apher Dial) Vol. 12 Issue 6 Pg. 469-74 (Dec 2008) ISSN: 1744-9987 [Electronic] Australia
PMID19140845 (Publication Type: Controlled Clinical Trial, Journal Article, Multicenter Study)
Chemical References
  • Hematinics
  • Hemoglobins
  • Recombinant Proteins
  • epoetin beta
  • Erythropoietin
Topics
  • Aged
  • Anemia (drug therapy)
  • Blood Pressure (drug effects)
  • Dose-Response Relationship, Drug
  • Erythropoietin (administration & dosage, adverse effects, therapeutic use)
  • Fatigue (chemically induced)
  • Female
  • Hematinics (administration & dosage, adverse effects, therapeutic use)
  • Hemoglobins (metabolism)
  • Humans
  • Injections, Intravenous
  • Male
  • Middle Aged
  • Prospective Studies
  • Recombinant Proteins
  • Renal Dialysis

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