title: Effectiveness and safety of recombinant human erythropoietin beta in maintaining common haemoglobin targets in routine clinical practice in Europe: the GAIN study.
abstract: OBJECTIVE
  The Gain effectiveness in Anaemia treatment wIth NeoRecormon (epoetin beta) study (GAIN) evaluated the effectiveness and safety of recombinant human erythropoietin beta in correcting and/or maintaining common haemoglobin (Hb) targets in routine clinical practice in Europe.
  
  
  METHODS
  European 18-month observational, prospective clinical practice study across 217 centres from 13 countries. During a 3-month retrospective period, patients received any erythropoiesis stimulating agent (ESA). For the subsequent 18-month study phase, patients receiving intravenous (IV) epoetin beta or any other ESA were recommended to be switched to subcutaneous (SC) epoetin beta. Presence of anti-erythropoietin antibodies (AEAB) and related outcomes was investigated before and during the study.
  
  
  BACKGROUND
  ClinicalTrials.gov number: NCT00551603.
  
  
  METHODS
  Correction and maintenance of Hb levels within recommended target range and mean dose requirement to correct and maintain target Hb levels.
  
  
  RESULTS
  A total of 4264 patients on haemodialysis received an ESA for treatment of renal anaemia. During the study period, the number of patients who maintained Hb levels in the recommended target range of 10-12 g/dL increased from 57% to 62%. Administration of SC epoetin beta resulted in a 24% lower mean dose requirement to maintain target Hb levels compared to IV administration (p < 0.001). Considerable differences were observed between countries in the study. No patients developed pure red cell aplasia associated with AEAB during observation.
  
  
  CONCLUSIONS
  This observational study suggests that haemodialysis patients who are receiving any ESA via SC or IV administration for treatment of their renal anaemia can be safely and effectively switched to SC epoetin beta to achieve or maintain the currently recommended Hb targets. SC required a lower dose than IV administration to maintain similar efficacy, thereby potentially lowering the drug costs.
authors.affiliation: Department of Nephrology & Transplantation Medicine, Medizinische Klinik III, Westpfalz-Klinikum GmbH, Kaiserslautern, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Rath
authors.forename: Robert A
authors.initials: RA
authors.lastname: Mactier
authors.forename: Thomas
authors.initials: T
authors.lastname: Weinreich
authors.forename: Armin W
authors.initials: AW
authors.lastname: Scherhag
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000740:Anemia / Q000188:drug therapy / Q000209:etiology; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005060:Europe; D006454:Hemoglobins / Q000187:drug effects / Q000378:metabolism*; D006801:Humans; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D007676:Kidney Failure, Chronic / Q000150:complications / Q000209:etiology; D008875:Middle Aged; D011994:Recombinant Proteins; D006435:Renal Dialysis; D012189:Retrospective Studies; D012449:Safety; D055815:Young Adult
chemical_list: D006454:Hemoglobins; D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin