Subcutaneous Epoetin Beta in Renal Anemia: An Open Multicenter Dose Titration Study of Patients on Continuous Peritoneal Dialysis

Abstract

Objective To establish dose requirements (target hemoglobin >100 g/L) and safety of subcutaneously administered epoetin beta. Design Open multicenter study. Patients Forty-five anemic patients (21 female, 24 male; mean age 55 years; range 20 79 years) who had been on continuous peritoneal dialysis for 1-157 months (mean 24 months). Thirty patients required blood transfusions during the year prior to the study. Mean hemoglobin concentration pretreatment was 75 g/L (range 57 –89 g/L). Intervention After a pretreatment period of two weeks, 60 IU kg-1 week-1 divided into three weekly doses of epoetin beta was administered subcutaneously. The dose was increased by 60 IU kg-1 week-1 after ten weeks, and when necessary, every fourth week in patients with hemoglobin levels below 100 g/L. Main Outcome Measures Hemoglobin concentration. Analysis of factors affecting the response to epoetin beta. Safety of epoetin beta. Results Thirty-eight of the 45 patients completed six months and 21 patients completed one year in the study. Twenty-six patients reached hemoglobin 100 g/L within six months and 8 patients did later on. The mean hemoglobin concentration after three months was 93 g/L (range 64 –144 g/L) and after six months was 99 g/L (range 59 –130 g/L; mean epoetin beta dose 1221U kg-1 week-I). During the second six-month period of the study, hemoglobin levels were stable in most patients. After one year, the mean hemoglobin was 110 g/L (range 84 –153 g/L) and the mean epoetin beta dose was 1071U kg-1 week-l. Prolonged correction time and impaired response to epoetin were observed in patients with infections or hemorrhages and in patients with low hemoglobin concentration before starting epoetin treatment. Iron deficiency was controlled by iron supplementation, either orally or, in 10 patients, intravenously. Increased blood pressure, requiring intensified antihypertensive treatment, was observed in 13 patients. Conclusions Continuous peritoneal dialysis patients with moderate anemia (Hb 75 –90 g/L) and without complicating disorders can be managed with subcutane0usdoses of ep0etin<1201U kg-lweek-l. Theepoetin beta dose should be adjusted after the first month of treatment since most patients required higher doses than the initial 60 IU kg-1 week-l.