title: Tolerability and efficacy of multidose epoetin beta (Reco-Pen) for subcutaneous administration in patients with anemia due to renal failure.
abstract: OBJECTIVE
  To assess the tolerability, safety and efficacy of the epoetin beta multidose cartridge formulation, self-administered subcutaneously via a pen device (Reco-Pen), in adult patients with renal anemia.
  
  
  METHODS
  Patients receiving maintenance epoetin therapy were switched to the subcutaneous (SC) multidose formulation of epoetin beta (NeoRecormon). The frequency of adverse events, local tolerability, and changes in blood pressure and laboratory variables were recorded. Hematologic parameters, transfusion requirements and epoetin beta dosage were also assessed.
  
  
  RESULTS
  A total of 406 patients were entered in the intention-to-treat analysis. Mean treatment duration was 82.3 days. Fifty patients (12.3%) withdrew from the study; 14 (3.4%) discontinued because of adverse events. Treatment was well tolerated, with adverse events considered probably related to treatment in only 5 cases, and 1 case of local intolerability. There were no clinically significant changes in blood pressure or laboratory variables, and no changes in hematologic parameters or transfusion requirements. Unexpectedly, the epoetin beta dose was reduced by almost one-third in patients previously maintained on SC epoetin.
  
  
  CONCLUSIONS
  SC administration of this multidose epoetin beta formulation with the Reco-Pen device was well tolerated and effective. It is possible that the improved capacity to individualize dose may have contributed to the considerable reduction in SC epoetin beta dosage requirement.
authors.affiliation: Gemeinschaftspraxis Karlstrasse, Düsseldorf, Germany. kleophas@nierenpraxis.de
authors.forename: W
authors.initials: W
authors.lastname: Kleophas
authors.forename: J
authors.initials: J
authors.lastname: Kult
authors.forename: W
authors.initials: W
authors.lastname: Kreusser
authors.forename: C
authors.initials: C
authors.lastname: Piper
authors.forename: H
authors.initials: H
authors.lastname: Plache
authors.forename: P
authors.initials: P
authors.lastname: Wunderle
authors.forename: V
authors.initials: V
authors.lastname: Fiegel
authors.forename: W
authors.initials: W
authors.lastname: Härtl
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology*; D001803:Blood Transfusion; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D006400:Hematocrit; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D051437:Renal Insufficiency / Q000150:complications*; D012646:Self Administration
chemical_list: D006454:Hemoglobins; D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin