Comparison of the therapeutic effects of epoetin zeta and epoetin alpha in the correction of renal anaemia.

Abstract

OBJECTIVE:

To assess the therapeutic equivalence of epoetin zeta and epoetin alpha for correction of haemoglobin (Hb) concentration in patients with anaemia and chronic kidney disease (CKD) stage 5 maintained on haemodialysis.

STUDY DESIGN:

In total, 609 patients with CKD and anaemia (Hb < 9 g/dL) were randomly assigned to receive either epoetin zeta or epoetin alpha intravenously, one to three times per week for 24 weeks. Dosing was titrated individually to achieve a stable, target Hb concentration of 11-12 g/dL. Primary endpoints were the mean weekly dose of epoetin per kilogram of body weight and mean Hb concentration during the last 4 weeks of treatment. Safety endpoints were the occurrence of anti-erythropoietin antibodies, ratings of tolerability and adverse events (AEs).

RESULTS:

Mean (+/- standard deviation [SD]) Hb concentration over the last 4 weeks of treatment was 11.61 +/- 1.27 g/dL for patients receiving epoetin zeta, compared with 11.63 +/- 1.37 g/dL for patients receiving epoetin alpha (95% confidence interval [CI]: -0.25 to 0.20 g/dL). Mean (+/- SD) epoetin zeta weekly dose over the last 4 weeks of treatment was 182.20 +/- 118.11 IU/kg/wk, compared with 166.14 +/- 109.85 IU/kg/wk for epoetin alpha (95% CI: -3.21 to 35.34 IU/kg/wk). The most commonly reported AEs (> 5% of patients) were infections and infestations (12.5% and 12.8% of patients treated with epoetin zeta and epoetin alpha, respectively) and vascular disorders (8.5% and 8.9%, respectively). No patients developed neutralizing anti-erythropoietin antibodies.

CONCLUSIONS:

Epoetin zeta, administered intravenously, is therapeutically equivalent to epoetin alpha in the correction of low Hb concentration in patients with CKD undergoing haemodialysis. No unexpected AEs were seen and both epoetin zeta and epoetin alpha were well tolerated.

• Authors: Stefan Krivoshiev, Vasil V Todorov, Jacek Manitius, Stanislaw Czekalski, Paul Scigalla, Rossen Koytchev, Epoetin Zeta Study Group
• Journal: Current medical research and opinion (Curr Med Res Opin) Vol. 24 Issue 5 Pg. 1407-15 (May 2008) ISSN: 1473-4877 [Electronic] England
• PMID: 18394266 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Hemoglobins
• Recombinant Proteins
• epoetin zeta
• Erythropoietin
• Epoetin Alfa

Topics

• Adolescent
• Adult
• Aged
• Anemia (diagnosis, drug therapy, etiology)
• Confidence Intervals
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Epoetin Alfa
• Erythropoietin (administration & dosage, analogs & derivatives, pharmacokinetics)
• Female
• Follow-Up Studies
• Hemoglobins (drug effects, metabolism)
• Humans
• Infusions, Intravenous
• Kidney Failure, Chronic (complications, diagnosis, therapy)
• Male
• Middle Aged
• Recombinant Proteins
• Renal Dialysis (adverse effects, methods)
• Risk Assessment
• Severity of Illness Index
• Therapeutic Equivalency
• Treatment Outcome