title: Once-every-2-weeks and once-weekly epoetin beta regimens: equivalency in hemodialyzed patients.
abstract: BACKGROUND
  Currently, less frequent than once-weekly subcutaneous epoetin administration regimens were shown to be equally effective and safe as once-weekly schedules in stable predialysis and peritoneal dialysis patients. Bioequivalency of once-every-2-weeks and once-weekly subcutaneous administration of the same total dose of epoetin beta for the maintenance phase of anemia treatment in stable iron-replete long-term hemodialysis patients therefore was investigated prospectively.
  
  
  METHODS
  Two hundred seven stable selected hemodialysis patients without diabetes, acute illness, significant inflammation, malnutrition or hyperparathyroidism administered once-weekly subcutaneous epoetin beta and preserving stable hemoglobin levels between 10 and 12 g/dL (100 and 120 g/L; difference between maximum and minimum of 3 subsequent levels <or=2.5 g/dL [<or=25 g/L]) and optimal iron status for at least 8 weeks before inclusion were enrolled and randomly assigned to subcutaneous administration of the same total dose of epoetin beta either once every 2 weeks (group 2w; n = 104) or once weekly (group 1w; n = 103) for 24 weeks.
  
  
  RESULTS
  Per-protocol analyses (group 1w = 102 versus group 2w = 101) showed similar hemoglobin levels throughout the assessment period (weeks 13 to 24): mean, 11.38 g/dL; 95% confidence interval (CI), 11.23 to 11.54 versus 11.41 g/dL; 95% CI, 11.22 to 11.58. Mean difference was 0.028 g/dL (95% CI, -0.208 to 0.264) in the prespecified range (+/-0.5 g/dL). Epoetin dose ratio of group 2w to group 1w was 0.94 (95% CI, 0.813 to 1.076), also in the prespecified range of equivalence (0.80 to 1.25). Hemoglobin levels and epoetin doses were stable during the study irrespective of treatment schedule, with no differences between groups at any time. Both schedules were well tolerated.
  
  
  CONCLUSIONS
  Once-every-2-weeks and once-weekly subcutaneous epoetin beta regimens are equivalent in the maintenance phase of anemia treatment in long-term stable hemodialysis patients without diabetes, with similar safety profiles.
authors.affiliation: Dr. Carol Davila Teaching Hospital of Nephrology.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Mircescu
authors.forename: Liliana
authors.initials: L
authors.lastname: Gârneată
authors.forename: Alexandru
authors.initials: A
authors.lastname: Ciocâlteu
authors.forename: Ovidiu
authors.initials: O
authors.lastname: Golea
authors.forename: Mirela
authors.initials: M
authors.lastname: Gherman-Căprioară
authors.forename: Dimitrie
authors.initials: D
authors.lastname: Capsa
authors.forename: Eugen
authors.initials: E
authors.lastname: Mota
authors.forename: Paul
authors.initials: P
authors.lastname: Gusbeth-Tatomir
authors.forename: Adrian
authors.initials: A
authors.lastname: Ghenu
authors.forename: Simona
authors.initials: S
authors.lastname: Bălută
authors.forename: Niculae
authors.initials: N
authors.lastname: Constantinovici
authors.forename: Adrian Constantin
authors.initials: AC
authors.lastname: Covic
mesh_terms: D000328:Adult; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology*; D004921:Erythropoietin / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins; D006435:Renal Dialysis; D051437:Renal Insufficiency / Q000628:therapy; D013810:Therapeutic Equivalency; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin