Abstract | INTRODUCTION: 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.
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Authors | Stefan Krivoshiev, Volker Wizemann, Stanisław Czekalski, Adalbert Schiller, Steva Pljesa, Michael Wolf-Pflugmann, Marianne Siebert-Weigel, Rossen Koytchev, Angelika Bronn, Epoetin Zeta Study Group |
Journal | Advances in therapy
(Adv Ther)
Vol. 27
Issue 2
Pg. 105-17
(Feb 2010)
ISSN: 1865-8652 [Electronic] United States |
PMID | 20369312
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Hematinics
- Hemoglobins
- Recombinant Proteins
- epoetin zeta
- Erythropoietin
- Epoetin Alfa
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Topics |
- Adult
- Aged
- Anemia
(drug therapy, etiology)
- Epoetin Alfa
- Erythropoietin
(pharmacokinetics, therapeutic use)
- Female
- Hematinics
(pharmacokinetics, therapeutic use)
- Hemoglobins
(analysis)
- Humans
- Injections, Subcutaneous
- Kidney Failure, Chronic
(therapy)
- Male
- Middle Aged
- Recombinant Proteins
- Renal Dialysis
(adverse effects)
- Single-Blind Method
- Therapeutic Equivalency
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