Efficacy of Once‐weekly Intravenous Administration of Epoetin‐β as a Maintenance Treatment for Anemia in Japanese Hemodialysis Patients: A Multicenter,Open‐label Clinical Study

Epoetin‐β 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‐β 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‐β, 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‐β, 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‐β is useful as maintenance treatment of anemia in HD patients and may be a treatment option.