PMID- 18394266 OWN - NLM STAT- MEDLINE DCOM- 20080722 LR - 20220410 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 24 IP - 5 DP - 2008 May TI - Comparison of the therapeutic effects of epoetin zeta and epoetin alpha in the correction of renal anaemia. PG - 1407-15 AB - 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. FAU - Krivoshiev, Stefan AU - Krivoshiev S AD - Multidisciplinary Hospital for Active Treatment Queen Giovanna Ltd., Sofia, Bulgaria. FAU - Todorov, Vasil V AU - Todorov VV FAU - Manitius, Jacek AU - Manitius J FAU - Czekalski, Stanislaw AU - Czekalski S FAU - Scigalla, Paul AU - Scigalla P FAU - Koytchev, Rossen AU - Koytchev R CN - Epoetin Zeta Study Group LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20080404 PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Hemoglobins) RN - 0 (Recombinant Proteins) RN - 0 (epoetin zeta) RN - 11096-26-7 (Erythropoietin) RN - 64FS3BFH5W (Epoetin Alfa) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Anemia/diagnosis/*drug therapy/etiology MH - Confidence Intervals MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Drug Administration Schedule MH - Epoetin Alfa MH - Erythropoietin/*administration & dosage/analogs & derivatives/pharmacokinetics MH - Female MH - Follow-Up Studies MH - Hemoglobins/drug effects/metabolism MH - Humans MH - Infusions, Intravenous MH - Kidney Failure, Chronic/complications/diagnosis/*therapy MH - Male MH - Middle Aged MH - Recombinant Proteins MH - Renal Dialysis/adverse effects/methods MH - Risk Assessment MH - Severity of Illness Index MH - Therapeutic Equivalency MH - Treatment Outcome FIR - Kraev, Zdravko E IR - Kraev ZE FIR - Todorova, Svetlana K IR - Todorova SK FIR - Osichenko, Alexander I IR - Osichenko AI FIR - Todorov, Nikolai G IR - Todorov NG FIR - Paunova, Pavlina IR - Paunova P FIR - Shikov, Peter J IR - Shikov PJ FIR - Mihailova, Vyara IR - Mihailova V FIR - Bogov, Boris I IR - Bogov BI FIR - Kumchev, Emil IR - Kumchev E FIR - Nenov, Kiril S IR - Nenov KS FIR - Rangelov, Rangel IR - Rangelov R FIR - Manueljan, Loris IR - Manueljan L FIR - Nowicki, Michal IR - Nowicki M FIR - Ostrowski, Janusz IR - Ostrowski J FIR - Sadowski, Leszek IR - Sadowski L FIR - Muszytowski, Marek IR - Muszytowski M FIR - Felisiak, Jacek IR - Felisiak J FIR - de Mezer-Dambek, Maria IR - de Mezer-Dambek M FIR - Dziewanowski, Krzysztof IR - Dziewanowski K FIR - Lange, Bogdan IR - Lange B FIR - Sulowicz, Wladyslaw IR - Sulowicz W FIR - Hruby, Zbigniew IR - Hruby Z FIR - Horbacz, Roman IR - Horbacz R FIR - Janas, Marzena IR - Janas M FIR - Kloczkowska-Trzciniecka, Malgorzata IR - Kloczkowska-Trzciniecka M FIR - Sliwicka, Dorota IR - Sliwicka D FIR - Cukuranovic, Rade IR - Cukuranovic R FIR - Lazarevic, Marina IR - Lazarevic M FIR - Pljesa, Steva IR - Pljesa S FIR - Dimkovic, Nada B IR - Dimkovic NB FIR - Zafirovska, Katica IR - Zafirovska K FIR - Wolf-Pflugmann, Michael IR - Wolf-Pflugmann M FIR - Siebert-Weigel, Marianne IR - Siebert-Weigel M FIR - Hansen, Peter IR - Hansen P FIR - Hesse, Jan-Ole IR - Hesse JO FIR - Casadevall, Nicole IR - Casadevall N FIR - Kromminga, Arno IR - Kromminga A FIR - Koch, Karl-Martin IR - Koch KM FIR - Eckardt, Kai-Uwe IR - Eckardt KU FIR - Pfarr, Egon IR - Pfarr E FIR - Weber, Rudiger IR - Weber R FIR - Bronn, Angelika IR - Bronn A FIR - Djarkova, Tsvetelina M IR - Djarkova TM FIR - Kaminski, Janusz IR - Kaminski J EDAT- 2008/04/09 09:00 MHDA- 2008/07/23 09:00 CRDT- 2008/04/09 09:00 PHST- 2008/04/09 09:00 [pubmed] PHST- 2008/07/23 09:00 [medline] PHST- 2008/04/09 09:00 [entrez] AID - 4444 [pii] AID - 10.1185/030079908x297402 [doi] PST - ppublish SO - Curr Med Res Opin. 2008 May;24(5):1407-15. doi: 10.1185/030079908x297402. Epub 2008 Apr 4.