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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

Recombinant Human Erythropoietin in the Treatment of Acute Ischemic Stroke

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  • Medientyp: E-Artikel
  • Titel: Recombinant Human Erythropoietin in the Treatment of Acute Ischemic Stroke
  • Beteiligte: 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
  • Erschienen: Ovid Technologies (Wolters Kluwer Health), 2009
  • Erschienen in: Stroke
  • Sprache: Englisch
  • DOI: 10.1161/strokeaha.109.564872
  • ISSN: 0039-2499; 1524-4628
  • Schlagwörter: Advanced and Specialized Nursing ; Cardiology and Cardiovascular Medicine ; Neurology (clinical)
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:p> <jats:bold> <jats:italic>Background and Purpose—</jats:italic> </jats:bold> 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. </jats:p> <jats:p> <jats:bold> <jats:italic>Methods—</jats:italic> </jats:bold> 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. </jats:p> <jats:p> <jats:bold> <jats:italic>Results—</jats:italic> </jats:bold> 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 ( <jats:italic>P</jats:italic> =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; <jats:italic>P</jats:italic> =0.01) without any particular mechanism of death unexpected after stroke. </jats:p> <jats:p> <jats:bold> <jats:italic>Conclusions—</jats:italic> </jats:bold> 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. </jats:p>
  • Zugangsstatus: Freier Zugang