A Single Bolus of a Long-acting Erythropoietin Analogue Darbepoetin Alfa in Patients with Acute Myocardial Infarction: A Randomized Feasibility and Safety Study
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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 μg 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/μl 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.
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- A Single Bolus of a Long-acting Erythropoietin Analogue Darbepoetin Alfa in Patients with Acute Myocardial Infarction: A Randomized Feasibility and Safety Study
Cardiovascular Drugs and Therapy
Volume 20, Issue 2 , pp 135-141
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- Kluwer Academic Publishers
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- acute myocardial infarction
- endothelial progenitor cells
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- Author Affiliations
- 1. Departments of Cardiology, University Medical Center Groningen, University of Groningen, The Netherlands
- 2. Clinical Pharmacology, University Medical Center Groningen, University of Groningen, The Netherlands
- 4. Hanzeplein 1, 9700 RB, Groningen, The Netherlands
- 3. Department of Nephrology and Hypertension, Leiden University Medical Center, University of Leiden, The Netherlands