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Therapeutic Research
Abstract
Background and aim:Recombinant human erythropoietin(rHuEPO)was used widely totreat renal anemia, but patients had to have weekly or biweekly medical examinations to beadministrated rHuEPO, and it was still difficult to achieve recommended hemoglobin level.Recently, Darbepoetin (DA), a long-acting erythropoiesis stimulating agent (ESA) wasapproved in Japan for renal anemia patients with chronic kidney disease not on dialysis(CKDND),and it enabled to extend ESA dosing interval to once a month in hemoglobin maintenancephase. We conducted a clinical study to determine the efficacy and safety of monthly DA administration in CKD-ND patients.Patients and methods:CKD-ND outpatients with renal anemia, but without a history ofcardiovascular diseases were included. Patients changed ESA from rHuEPO to monthly DAtreatment(n=50, group C), ESA naïve patients newly starting with monthly DA treatment(n=30, group D)and historical control patients(n=30, group E)were followed. ESA(DAor rHuEPO)dosage was adjusted to maintain hemoglobin level at 11.0~13.0 g/dL. Primaryendpoint was deterioration rate of estimated glomerular filtration ratio(ΔeGFR, mL/min/1.73 m2/year).Results:No deaths or cardiovascular events were occurred. Ten patients in group Cwas inducted to hemodialysis. ΔeGFR was improved from -2.53 to -1.25 by the treatmentchange in group C but not significantly(p=0.81). ΔeGFR in group D(-0.07)was smallerthan that in group E(-1.70, p=0.78). The hemoglobin increasing rate by DA was less than0.5 g/dL/week, satisfying the level recommended by the guideline.Conclusion:The present study suggests the effectiveness of a monthly administrationof DA for improving anemia and preventing CKD progression. It also suggests the safety ofmonthly administration of DA.
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