title: Once-weekly compared with three-times-weekly subcutaneous epoetin beta: results from a randomized, multicenter, therapeutic-equivalence study.
abstract: BACKGROUND
  The ability to reduce the administration frequency of subcutaneous (SC) epoetin could provide benefits. This multicenter open-label study investigated the therapeutic equivalence of SC epoetin beta once-weekly and thrice-weekly administration regimens in maintaining anemia correction in stable hemodialysis (HD) patients.
  
  
  METHODS
  One hundred seventy-three patients were randomly assigned to either once-weekly epoetin beta (n = 84) or their original thrice-weekly regimen (n = 89) for 24 weeks. All patients were administered intravenous iron supplementation, as required.
  
  
  RESULTS
  The per-protocol analysis included 134 patients (69 patients, once-weekly group; 65 patients, thrice-weekly group). Mean hematocrits in both groups remained stable throughout the study. The difference in mean time-adjusted area under the curve for hematocrits between the once-weekly and thrice-weekly groups (-0.54 vol%) and 90% confidence intervals (-1.27 to 0.19) were within the prespecified equivalence range (-2 to +2 vol%). There was no significant change in epoetin beta dose during the study. The ratio of mean weekly epoetin beta doses in the once-weekly and thrice-weekly groups (1.11) and 90% confidence interval (0.99 to 1.23) also remained within the prespecified range (0.8 to 1.25). Intention-to-treat analysis results were similar to per-protocol analysis results. Both regimens were well tolerated.
  
  
  CONCLUSIONS
  Once-weekly and thrice-weekly SC epoetin beta administrations are statistically equivalent in terms of maintaining both stable hematocrits and epoetin beta dose requirements in HD patients. These findings may improve compliance among patients.
authors.affiliation: Divisione di Nefrologia e Dialisi, Ospedale A. Manzoni, Lecco, Italy. nefrologia@ospedale.lecco.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Locatelli
authors.forename: Conrad A
authors.initials: CA
authors.lastname: Baldamus
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Villa
authors.forename: Alexandru
authors.initials: A
authors.lastname: Ganea
authors.forename: Angel L
authors.initials: AL
authors.lastname: Martín de Francisco
mesh_terms: D000740:Anemia / Q000188:drug therapy; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000008:administration & dosage* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D006435:Renal Dialysis / Q000379:methods; D013810:Therapeutic Equivalency
chemical_list: D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin