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document
Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment . OBJECTIVE To evaluate the therapeutic efficacy and safety of epoetin zeta , compared with epoetin alfa , in maintaining target haemoglobin ( Hb ) concentrations in patients with anaemia and chronic kidney disease ( CKD ) maintained on haemodialysis . METHODS Patients received epoetin zeta or epoetin alfa intravenously , 1-3 times/week for 12 weeks , then the alternative treatment for 12 weeks , in this double-blind , crossover , phase III trial . Eligible patients were 18-75 years old with CKD stage 5 maintained on haemodialysis . Patients had received epoetin for > or = 3 months upon study entry and had achieved a target Hb level of 10.5-12.5 g/dL with a stable epoetin dose . MAIN OUTCOME MEASURES Primary efficacy endpoints were intra-individual differences ( test-reference ) in mean Hb levels and mean weekly dose/kg of body weight . Safety endpoints included occurrence of neutralizing anti-erythro poietin antibodies , tolerability , and adverse events ( AEs ) . RESULTS In total , 313 patients were randomized to receive epoetin zeta ( n = 155 ) or epoetin alfa ( n = 158 ) ; 146 and 145 patients ( respectively ) switched treatment after 12 weeks . Mean ( range ) Hb levels were 11.35 ( 8.96-14.22 ) g/dL and 11.54 ( 8.74-13.84 ) g/dL for patients receiving epoetin zeta and epoetin alfa , respectively ( 95 % confidence interval [ CI ] [ test-reference ] : 0.09-0.28 g/dL , within the predefined equivalence range of +/-0.6 g/dL ) . Mean ( range ) weekly doses were 92.68 ( 12.74-398.41 ) IU/kg/wk and 92.58 ( 10.53-393.07 ) IU/kg/wk for patients receiving epoetin zeta and epoetin alfa , respectively ( 95 % CI [ test-reference ] : -4.67 and 4.29 IU/kg/wk , within the equivalence range of +/-45.00 IU/kg/wk ) . Patients underwent minor nominal dose adjustments during treatment crossover . AE profile was similar for both products ; the most commonly reported AEs were infections and infestations ( in 26.5 % of patients receiving epoetin zeta and 23.6 % receiving epoetin alfa ) . No patients developed neutralizing anti-erythropoietin antibodies . CONCLUSIONS Epoetin zeta is therapeutically equivalent to epoetin alfa in the maintenance of target Hb levels in patients with renal anaemia . No unexpected AEs were seen .
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Intervention_Pharmacological
epoetin zeta
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Intervention_Pharmacological
epoetin alfa
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Intervention_Pharmacological
epoetin zeta
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Intervention_Pharmacological
epoetin alfa
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Intervention_Pharmacological
epoetin zeta
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Intervention_Pharmacological
epoetin alfa
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Intervention_Pharmacological
epoetin
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Intervention_Pharmacological
epoetin
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Intervention_Pharmacological
epoetin zeta
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Intervention_Pharmacological
epoetin alfa
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Intervention_Pharmacological
epoetin zeta
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Intervention_Pharmacological
epoetin alfa
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Intervention_Pharmacological
Epoetin zeta
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Outcome_Physical
occurrence of neutralizing anti-erythro poietin antibodies
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Outcome_Other
tolerability
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Outcome_Adverse-effects
adverse events ( AEs )
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Outcome_Physical
Mean ( range ) Hb levels
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Outcome_Other
Mean ( range ) weekly doses
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Outcome_Adverse-effects
infections and infestations
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Outcome_Other
neutralizing anti-erythropoietin antibodies
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Participant_Condition
renal anaemia
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Participant_Condition
anaemia and chronic kidney disease ( CKD )
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Participant_Age
18-75 years old
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Participant_Condition
CKD stage 5
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Participant_Sample-size
313 patients
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Participant_Condition
renal anaemia