Data from a German study suggest that IV-administered epoetin zeta—a new erythropoietin preparation—is safe for maintenance treatment of anemia in patients with end-stage renal disease.
A total of 745 chronic hemodialysis patients, enrolled in 65 centers across Germany, Bulgaria, Poland, and Serbia, were studied. All subjects received epoetin zeta IV one to three times per week for 56 weeks. A subgroup of 164 Bulgarian patients received the treatment for 108 weeks.
The object was to maintain hemoglobin values between 10.5 and 12.5 g/dL with constant epoetin dosage. The primary end points were the formation of anti-erythropoietin antibodies and the evaluation of adverse events (AEs). Neutralizing anti-erythropoietin antibodies did not develop in any patient. Serious AEs were reported by 37.3% of patients.
A previously published study (Curr Med Res Opin. 2008;24:625-637) found that the AE profile of epoetin zeta was similar to that of epoetin alfa, and both drugs were therapeutically equivalent in the maintenance of target hemoglobin levels in patients with renal anemia. No unexpected AEs were observed.