PMID- 20369312
OWN - NLM
STAT- MEDLINE
DCOM- 20100721
LR  - 20220410
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Linking)
VI  - 27
IP  - 2
DP  - 2010 Feb
TI  - Therapeutic equivalence of epoetin zeta and alfa, administered subcutaneously, 
      for maintenance treatment of renal anemia.
PG  - 105-17
LID - 10.1007/s12325-010-0012-y [doi]
AB  - INTRODUCTION: The primary objective of the trial was to prove the therapeutic 
      equivalence of epoetin zeta to epoetin alfa when administered subcutaneously for 
      maintaining target hemoglobin (Hb) in patients with renal anemia on chronic 
      hemodialysis. Additional information was provided on the safety and tolerability 
      of epoetin zeta with particular focus on the formation of anti-erythropoietin 
      antibodies. METHODS: A total of 462 patients were randomized to either epoetin 
      zeta or alfa for 28 weeks after an open period of dose adjustment of 12-16 weeks 
      with only epoetin zeta. The aim of treatment was to maintain Hb between 10.0-12.0 
      g/dL with constant epoetin dosage. Primary endpoints were the mean Hb level and 
      the mean weekly epoetin dosage during the last 4 weeks of treatment. Safety 
      endpoints were the occurrence of anti-erythropoietin antibodies, incidence of Hb 
      levels above 13 g/dL, ratings of tolerability, and adverse events (AEs). RESULTS: 
      The mean Hb level (+/-SD) during the last 4 weeks of treatment was 10.94+/-0.84 
      g/dL (epoetin zeta) and 11.02+/-0.94 g/dL (epoetin alfa). The 95% confidence 
      interval (CI) (''C0.28 g/dL to 0.12 g/dL) was entirely within the predefined 
      equivalence range (+/-0.5 g/dL). The mean weekly epoetin dosage per body weight 
      over the last 4 weeks of treatment was 97.0+/-94.3 IU/kg/week (epoetin zeta) and 
      86.0+/-78.0 IU/kg/week (epoetin alfa). The 95% CI (''C8.06 IU/kg/week to 29.96 
      IU/kg/week) was also within the predefined equivalence range of +/-45 IU/kg/week. 
      The most common AEs were infections and infestations (15.1% of patients on 
      epoetin zeta and 14.8% of patients on epoetin alfa). None of the patients 
      developed anti-erythropoietin antibodies. CONCLUSIONS: Epoetin zeta, administered 
      subcutaneously, is equivalent to epoetin alfa in respect of its clinical 
      efficacy. The safety profile of both products is similar: no unexpected AEs were 
      observed, no patients developed anti-erythropoietin antibodies, and both epoetin 
      preparations were well tolerated.
FAU - Krivoshiev, Stefan
AU  - Krivoshiev S
AD  - Multidisciplinary Hospital for Active Treatment Queen Giovanna Ltd., Sofia, 
      Bulgaria.
FAU - Wizemann, Volker
AU  - Wizemann V
FAU - Czekalski, Stanislaw
AU  - Czekalski S
FAU - Schiller, Adalbert
AU  - Schiller A
FAU - Pljesa, Steva
AU  - Pljesa S
FAU - Wolf-Pflugmann, Michael
AU  - Wolf-Pflugmann M
FAU - Siebert-Weigel, Marianne
AU  - Siebert-Weigel M
FAU - Koytchev, Rossen
AU  - Koytchev R
FAU - Bronn, Angelika
AU  - Bronn A
CN  - Epoetin Zeta Study Group
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100330
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Hematinics)
RN  - 0 (Hemoglobins)
RN  - 0 (Recombinant Proteins)
RN  - 0 (epoetin zeta)
RN  - 11096-26-7 (Erythropoietin)
RN  - 64FS3BFH5W (Epoetin Alfa)
MH  - Adult
MH  - Aged
MH  - Anemia/*drug therapy/etiology
MH  - Epoetin Alfa
MH  - Erythropoietin/pharmacokinetics/*therapeutic use
MH  - Female
MH  - Hematinics/pharmacokinetics/*therapeutic use
MH  - Hemoglobins/analysis
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Kidney Failure, Chronic/therapy
MH  - Male
MH  - Middle Aged
MH  - Recombinant Proteins
MH  - Renal Dialysis/adverse effects
MH  - Single-Blind Method
MH  - Therapeutic Equivalency
FIR - Kraev, Z
IR  - Kraev Z
FIR - Nenchev, N
IR  - Nenchev N
FIR - Todorov, N
IR  - Todorov N
FIR - Paunova, P
IR  - Paunova P
FIR - Shikov, D P
IR  - Shikov DP
FIR - Mihaylova-Tserovska, V
IR  - Mihaylova-Tserovska V
FIR - Todorov, V
IR  - Todorov V
FIR - Kumchev, E
IR  - Kumchev E
FIR - Nenov, K
IR  - Nenov K
FIR - Rangelov, R
IR  - Rangelov R
FIR - Kambova, L
IR  - Kambova L
FIR - Manuelyan, L
IR  - Manuelyan L
FIR - Karagyozova-Todorova, R
IR  - Karagyozova-Todorova R
FIR - Lange, B
IR  - Lange B
FIR - Wruk, K
IR  - Wruk K
FIR - Juzwiuk, J
IR  - Juzwiuk J
FIR - Naruszewicz, R
IR  - Naruszewicz R
FIR - Trafny, R
IR  - Trafny R
FIR - Zygadlo, H
IR  - Zygadlo H
FIR - Matulewicz-Gilewicz, J
IR  - Matulewicz-Gilewicz J
FIR - Muszytowski, M
IR  - Muszytowski M
FIR - Hryniewicz, B
IR  - Hryniewicz B
FIR - Ciechanowski, K
IR  - Ciechanowski K
FIR - Rajca, D
IR  - Rajca D
FIR - Nadrajkowska, M
IR  - Nadrajkowska M
FIR - Uxar, J
IR  - Uxar J
FIR - Wyroslak, J
IR  - Wyroslak J
FIR - Bako, G
IR  - Bako G
FIR - Craciun, I
IR  - Craciun I
FIR - Avram, R
IR  - Avram R
FIR - Rusan, C
IR  - Rusan C
FIR - Djordjevic, V
IR  - Djordjevic V
FIR - Poskurica, M
IR  - Poskurica M
FIR - Dimkovic, N
IR  - Dimkovic N
EDAT- 2010/04/07 06:00
MHDA- 2010/07/22 06:00
CRDT- 2010/04/07 06:00
PHST- 2009/10/19 00:00 [received]
PHST- 2010/04/07 06:00 [entrez]
PHST- 2010/04/07 06:00 [pubmed]
PHST- 2010/07/22 06:00 [medline]
AID - 10.1007/s12325-010-0012-y [doi]
PST - ppublish
SO  - Adv Ther. 2010 Feb;27(2):105-17. doi: 10.1007/s12325-010-0012-y. Epub 2010 Mar 
      30.