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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

  • Clinical Pharmacology and Drug Studies
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Abstract

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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Authors and Affiliations

  1. Departments of Cardiology, University Medical Center Groningen, University of Groningen, The Netherlands

    Erik Lipšic, Peter van der Meer, Adriaan A. Voors, B. Daan Westenbrink, Ad F. M. van den Heuvel, Regien G. Schoemaker, Wiek H. van Gilst, Felix Zijlstra & Dirk J. van Veldhuisen

  2. Clinical Pharmacology, University Medical Center Groningen, University of Groningen, The Netherlands

    Erik Lipšic, Peter van der Meer, B. Daan Westenbrink, Regien G. Schoemaker & Wiek H. van Gilst

  3. Department of Nephrology and Hypertension, Leiden University Medical Center, University of Leiden, The Netherlands

    Hetty C. de Boer & Anton J. van Zonneveld

  4. Hanzeplein 1, 9700 RB, Groningen, The Netherlands

    Erik Lipšic

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  1. Erik Lipšic
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Correspondence to Erik Lipšic.

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Lipšic, E., van der Meer, P., Voors, A.A. et al. A Single Bolus of a Long-acting Erythropoietin Analogue Darbepoetin Alfa in Patients with Acute Myocardial Infarction: A Randomized Feasibility and Safety Study. Cardiovasc Drugs Ther 20, 135–141 (2006). https://doi.org/10.1007/s10557-006-7680-5

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  • DOI: https://doi.org/10.1007/s10557-006-7680-5

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