Recombinant Human Erythropoietin in the Treatment of Acute Ischemic Stroke
2009-12 | journal article
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Recombinant Human Erythropoietin in the Treatment of Acute Ischemic Stroke
Ehrenreich, H. ; Weißenborn, K.; Prange, H. ; Schneider, D.; Weimar, C.; Wartenberg, K. & Schellinger, P. D. et al. (2009)
Stroke, 40(12) pp. e647-e656. DOI: https://doi.org/10.1161/STROKEAHA.109.564872
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Details
- Authors
- Ehrenreich, Hannelore ; Weißenborn, Karin; Prange, Hilmar ; Schneider, Dietmar; Weimar, Christian; Wartenberg, Katja; Schellinger, Peter D.; Bohn, Matthias ; Becker, Harald; Wegrzyn, Martin; Jähnig, Peter; Herrmann, Manfred; Knauth, Michael ; Bähr, Mathias ; Heide, Wolfgang; Wagner, Armin; Schwab, Stefan; Reichmann, Heinz; Schwendemann, Günther; Dengler, Reinhard; Kastrup, Andreas ; Bartels, Claudia
- Abstract
- Background and Purpose— Numerous preclinical findings and a clinical pilot study suggest that recombinant human erythropoietin (EPO) provides neuroprotection that may be beneficial for the treatment of patients with ischemic stroke. Although EPO has been considered to be a safe and well-tolerated drug over 2 decades, recent studies have identified increased thromboembolic complications and/or mortality risks on EPO administration to patients with cancer or chronic kidney disease. Accordingly, the double-blind, placebo-controlled, randomized German Multicenter EPO Stroke Trial (Phase II/III; ClinicalTrials.gov Identifier: NCT00604630) was designed to evaluate efficacy and safety of EPO in stroke.Methods— This clinical trial enrolled 522 patients with acute ischemic stroke in the middle cerebral artery territory (intent-to-treat population) with 460 patients treated as planned (per-protocol population). Within 6 hours of symptom onset, at 24 and 48 hours, EPO was infused intravenously (40 000 IU each). Systemic thrombolysis with recombinant tissue plasminogen activator was allowed and stratified for.Results— Unexpectedly, a very high number of patients received recombinant tissue plasminogen activator (63.4%). On analysis of total intent-to-treat and per-protocol populations, neither primary outcome Barthel Index on Day 90 (P=0.45) nor any of the other outcome parameters showed favorable effects of EPO. There was an overall death rate of 16.4% (n=42 of 256) in the EPO and 9.0% (n=24 of 266) in the placebo group (OR, 1.98; 95% CI, 1.16 to 3.38; P=0.01) without any particular mechanism of death unexpected after stroke.Conclusions— Based on analysis of total intent-to-treat and per-protocol populations only, this is a negative trial that also raises safety concerns, particularly in patients receiving systemic thrombolysis.
- Issue Date
- December-2009
- Journal
- Stroke
- Language
- English