AIMS: 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). METHODS AND 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.
RCT Entities:
AIMS: 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-anemicpatients with acute myocardial infarction (MI). METHODS AND 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: W T Ruifrok; B D Westenbrink; R A de Boer; I J den Hamer; M E Erasmus; H E Mungroop; A H Epema; A A Voors; D J van Veldhuisen; W H van Gilst Journal: Neth Heart J Date: 2010-05 Impact factor: 2.380
Authors: David Hefer; Ting Yi; Donald E Selby; David E Fishbaugher; Sarah M Tremble; Kelly J Begin; Prospero Gogo; Martin M Lewinter; Markus Meyer; Bradley M Palmer; Peter Vanburen Journal: J Mol Cell Cardiol Date: 2011-10-14 Impact factor: 5.000
Authors: Chiara Melloni; Sunil V Rao; Thomas J Povsic; Laura Melton; Raymond J Kim; Rakhi Kilaru; Manesh R Patel; Mark Talan; Luigi Ferrucci; Dan L Longo; Edward G Lakatta; Samer S Najjar; Robert A Harrington Journal: Am Heart J Date: 2010-11 Impact factor: 4.749
Authors: Yi-Da Tang; Faisal Hasan; Frank J Giordano; Stephen Pfau; Henry M Rinder; Stuart D Katz Journal: Am Heart J Date: 2009-12 Impact factor: 4.749