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


METHODS
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.
Krivoshiev
Stefan
S
Multidisciplinary Hospital for Active Treatment Queen Giovanna Ltd., Sofia, Bulgaria.
Todorov
Vasil V
VV
Manitius
Jacek
J
Czekalski
Stanislaw
S
Scigalla
Paul
P
Koytchev
Rossen
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D000740:Anemia / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage* / Q000031:analogs & derivatives / Q000493:pharmacokinetics; D005260:Female; D005500:Follow-Up Studies; D006454:Hemoglobins / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007262:Infusions, Intravenous; D007676:Kidney Failure, Chronic / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D006435:Renal Dialysis / Q000009:adverse effects / Q000379:methods; D018570:Risk Assessment; D012720:Severity of Illness Index; D013810:Therapeutic Equivalency; D016896:Treatment Outcome
D006454:Hemoglobins; D011994:Recombinant Proteins; C530192:epoetin zeta; D004921:Erythropoietin; D000068817:Epoetin Alfa