title: A single bolus of a long-acting erythropoietin analogue darbepoetin alfa in patients with acute myocardial infarction: a randomized feasibility and safety study.
abstract: OBJECTIVE
  Besides stimulating hematopoiesis, erythropoietin (EPO) protects against experimental ischemic injury in the heart. The present study evaluated the safety and tolerability of EPO treatment in non-anemic patients with acute myocardial infarction (MI).
  
  
  RESULTS
  In this single-center, investigator-initiated, prospective study, patients with a first acute MI were randomized to one bolus of 300 microg darbepoetin alfa or no additional medication before primary coronary intervention. Twenty-two patients (mean age 59 +/- 2 years) were included. In the darbepoetin group, serum EPO-levels increased to 130-270 times that of controls, within the first 24 h. After darbepoetin administration, only small and non-significant changes in hematocrit levels were observed, while endothelial progenitor cells (EPCs, CD34+/CD45-) were increased at 72 h (2.8 vs. 1.0 cells/microl in control group, p < 0.01). No adverse events were recorded during the 30-day follow-up. After 4 months, left ventricular ejection fraction was similar in the two groups (52 +/- 3% in darbepoetin vs. 48 +/- 5% in control group, p = NS).
  
  
  CONCLUSIONS
  Intravenous single high-dose darbepoetin alfa in acute MI is both safe and well tolerated. Darbepoetin treatment after MI stimulates EPCs mobilization. The results of this first pilot study support a larger scale clinical trial to establish efficacy of EPO administration in patients after acute MI.
authors.affiliation: Department of Cardiology, University Medical Center Groningen, University of Groningen, The Netherlands. e.lipsic@med.umcg.nl
authors.forename: Erik
authors.initials: E
authors.lastname: Lipsic
authors.forename: Peter
authors.initials: P
authors.lastname: van der Meer
authors.forename: Adriaan A
authors.initials: AA
authors.lastname: Voors
authors.forename: B Daan
authors.initials: BD
authors.lastname: Westenbrink
authors.forename: Ad F M
authors.initials: AF
authors.lastname: van den Heuvel
authors.forename: Hetty C
authors.initials: HC
authors.lastname: de Boer
authors.forename: Anton J
authors.initials: AJ
authors.lastname: van Zonneveld
authors.forename: Regien G
authors.initials: RG
authors.lastname: Schoemaker
authors.forename: Wiek H
authors.initials: WH
authors.lastname: van Gilst
authors.forename: Felix
authors.initials: F
authors.lastname: Zijlstra
authors.forename: Dirk J
authors.initials: DJ
authors.lastname: van Veldhuisen
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D018952:Antigens, CD34 / Q000032:analysis; D001772:Blood Cell Count / Q000379:methods; D001792:Blood Platelets / Q000166:cytology / Q000187:drug effects; D000068256:Darbepoetin alfa; D004562:Electrocardiography / Q000187:drug effects / Q000379:methods; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000097:blood / Q000627:therapeutic use; D005240:Feasibility Studies; D006329:Heart Conduction System / Q000187:drug effects; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007275:Injections, Intravenous; D017493:Leukocyte Common Antigens / Q000032:analysis; D008297:Male; D059630:Mesenchymal Stem Cells / Q000737:chemistry / Q000166:cytology / Q000187:drug effects; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D018579:Patient Selection; D011446:Prospective Studies; D012156:Reticulocytes / Q000166:cytology / Q000187:drug effects; D017180:Tachycardia, Ventricular / Q000139:chemically induced / Q000628:therapy; D016896:Treatment Outcome
chemical_list: D018952:Antigens, CD34; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa; D017493:Leukocyte Common Antigens