Abstract
Darbepoetin alfa is a new erythropoiesis stimulating protein with a three-fold longer terminal half-life than recombinant human erythropoietin (rHuEPO) in hemodialysis patients. This study investigated the safety and efficacy of darbepoetin alfa to treat anemia in hemodialysis patients when administered at a reduced dosing frequency. Dialysis patients (n=157) maintained on rHuEPO treatment (alfa or beta) were switched to darbepoetin alfa under the following doses : 10μg (n=35), 15μg (n=34), 20μg (n=38), 30μg (n=25), 40μg (n=25). Darbepoetin alfa administered intravenously once weekly during 10 weeks. Mean hemoglobin levels were elevated by 0.17±0.16 (SD) g/dL (10μg), 0.26±0.18g/dL (15μg), 0.20±0.20g/dL (20μg), 0.30±0.31g/dL(30μg), 0.44±0.51g/dL (40μg). The difference was significant(p<0.05). There was an increase in serum iron level, but decreases in serum ferritin and TSAT level after 10 weeks. It is suggested that darbepoetin therapy increases the rate of erythropoiesis and therefore the iron support should be considered. There were no major adverse events associated with darbepoetin alfa dosing during 10 weeks. However, two patients withdrew from the study due to adverse events(fatigue and flushing). These findings show that darbepoetin alfa increase hemoglobin concentrations effectively and safely in hemodialysis patients, but with a reduced dosing frequency.
