title: The safety and tolerability of darbepoetin alfa in patients with anaemia and symptomatic heart failure.
abstract: OBJECTIVE
  To assess the safety and tolerability of darbepoetin alfa (DA) in the treatment of anaemia in heart failure (HF).
  
  
  RESULTS
  In this pooled analysis of three randomized, double-blind, placebo-controlled studies of anaemic [haemoglobin (Hb) < or =12.0 g/dL or < or =12.5 g/dL] symptomatic HF subjects, DA was administered subcutaneously once every 2 weeks and titrated to achieve and maintain a target Hb of 14.0 +/- 1.0 g/dL. In total, 516 subjects were randomized; 231 (44.8%) to placebo, 285 (55.2%) to DA. Darbepoetin alfa was well tolerated, with an adverse event (AE) profile similar to placebo. Most subjects (placebo, 85%; DA, 87%) experienced at least one AE. There was a lower incidence of serious AEs in the DA group (placebo, 43%; DA, 37%) with the most frequent being worsening HF (placebo, 19%; DA, 11%). Treatment-related AEs were reported for 9% and 12% in placebo and DA subjects, respectively. Fewer deaths were reported in DA group (6%) vs. placebo (8%).
  
  
  CONCLUSIONS
  Darbepoetin alfa was well tolerated with an AE profile similar to placebo in HF subjects treated to a target Hb of 14.0 +/- 1.0 g/dL. Contrary to recent data in other patient populations, there was no evidence of increased risk of mortality or cardiovascular events.
authors.affiliation: Department of Cardiology, New Jersey Medical School, Newark, NJ, USA. klapholz@umdnj.edu
authors.forename: Marc
authors.initials: M
authors.lastname: Klapholz
authors.forename: William T
authors.initials: WT
authors.lastname: Abraham
authors.forename: Jalal K
authors.initials: JK
authors.lastname: Ghali
authors.forename: Piotr
authors.initials: P
authors.lastname: Ponikowski
authors.forename: Stefan D
authors.initials: SD
authors.lastname: Anker
authors.forename: Beat
authors.initials: B
authors.lastname: Knusel
authors.forename: Yan
authors.initials: Y
authors.lastname: Sun
authors.forename: Scott M
authors.initials: SM
authors.lastname: Wasserman
authors.forename: Dirk J
authors.initials: DJ
authors.lastname: van Veldhuisen
mesh_terms: D000368:Aged; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D000068256:Darbepoetin alfa; D004921:Erythropoietin / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006333:Heart Failure / Q000150:complications* / Q000188:drug therapy; D006397:Hematinics / Q000009:adverse effects*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic; D016019:Survival Analysis
chemical_list: D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa