TY - JOUR
T1 - A single bolus of a long-acting erythropoietin analogue darbepoetin alfa in patients with acute myocardial infarction
T2 - A randomized feasibility and safety study
AU - Lipsic, Erik
AU - van der Meer, Peter
AU - Voors, Adriaan A.
AU - Westenbrink, B. Daan
AU - van den Heuvel, Ad F. M.
AU - de Boer, Hetty C.
AU - van Zonneveld, Anton J.
AU - Schoemaker, Regien G.
AU - van Gilst, Wiek H.
AU - Zijlstra, Felix
AU - van Veldhuisen, Dirk J.
PY - 2006/4
Y1 - 2006/4
N2 - Aims: Besides stimulating hematopoiesis, erythro-poietin (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 mu g 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 nonsignificant changes in hematocrit levels were observed, while endothelial progenitor cells (EPCs, CD34+/CD45-) were increased at 72 h (2.8 vs. 1.0 cells/mu l 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.
AB - Aims: Besides stimulating hematopoiesis, erythro-poietin (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 mu g 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 nonsignificant changes in hematocrit levels were observed, while endothelial progenitor cells (EPCs, CD34+/CD45-) were increased at 72 h (2.8 vs. 1.0 cells/mu l 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.
KW - acute myocardial infarction
KW - erythropoietin
KW - endothelial progenitor cells
KW - ENDOTHELIAL PROGENITOR CELLS
KW - RECOMBINANT-HUMAN-ERYTHROPOIETIN
KW - LEFT-VENTRICULAR FUNCTION
KW - CHRONIC HEART-FAILURE
KW - HEMOGLOBIN LEVELS
KW - SIZE
KW - ANEMIA
KW - RATS
KW - HEMODIALYSIS
KW - MORTALITY
U2 - 10.1007/s10557-006-7680-5
DO - 10.1007/s10557-006-7680-5
M3 - Article
SN - 0920-3206
VL - 20
SP - 135
EP - 141
JO - Cardiovascular Drugs and Therapy
JF - Cardiovascular Drugs and Therapy
IS - 2
ER -