Abstract
IntroductionMortality and disability following ischemic stroke (IS) remains unacceptably high with respect to the conventional therapies. This study tested the effect of erythropoietin (EPO) on long-term neurological outcome in patients after acute IS. This study aimed to evaluate the safety and efficacy of two consecutive doses of EPO (5,000 IU/dose, subcutaneously administered at 48 hours and 72 hours after acute IS) on improving the 90-day combined endpoint of recurrent stroke or death that has been previously reported. A secondary objective was to evaluate the long-term (that is, five years) outcome of patients who received EPO.MethodsThis was a prospective, randomized, placebo-controlled trial that was conducted between October 2008 and March 2010 in a tertiary referral center. IS stroke patients who were eligible for EPO therapy were enrolled into the study.ResultsThe results showed that long-term recurrent stroke and mortality did not differ between group 1 (placebo-control; n = 71) and group 2 (EPO-treated; n = 71).Long-term Barthel index of <35 (defining a severe neurological deficit) was lower in group 2 than group 1 (P = 0.007). Multiple-stepwise logistic-regression analysis showed that EPO therapy was significantly and independently predictive of freedom from a Barthel index of <35 (P = 0.029). Long-term major adverse neurological event (MANE; defined as: death, recurrent stroke, or long-term Barthel index < 35) was lower in group 2 than group 1 (P = 0.04). Log-Rank test showed that MANE-free rate was higher in group 2 than group 1 (P = 0.031). Multiple-stepwise Cox-regression analysis showed that EPO therapy and higher Barthel Index at day 90 were independently predictive of freedom from long-term MANE (all P <0.04).ConclusionEPO therapy significantly improved long-term neurological outcomes in patients after IS.Trial registrationISRCTN71371114. Registered 10 October 2008.
Highlights
Mortality and disability following ischemic stroke (IS) remains unacceptably high with respect to the conventional therapies
Multiple-stepwise Cox-regression analysis showed that EPO therapy and higher Barthel Index at day 90 were independently predictive of freedom from long-term major adverse neurological event (MANE)
Given the pleiotropic effects of EPO therapy, the inconsistent clinical outcomes of EPO therapy after acute IS in clinical reports and our previous finding that an increase in circulating levels of endothelial progenitor cell (EPC) in patients after acute IS was significantly associated with favorable clinical outcomes [23], we performed a prospective, randomized, and placebo-controlled trial [24]
Summary
Mortality and disability following ischemic stroke (IS) remains unacceptably high with respect to the conventional therapies. This study aimed to evaluate the safety and efficacy of two consecutive doses of EPO (5,000 IU/dose, subcutaneously administered at 48 hours and 72 hours after acute IS) on improving the 90-day combined endpoint of recurrent stroke or death that has been previously reported. The primary objective of this clinical trial was to evaluate the safety and efficacy of two consecutive doses of EPO (5,000 IU per dose, subcutaneously administered at 48 hours and 72 hours after acute IS, Epoetin beta; Roche) on improving the 90-day combined endpoint of recurrent stroke or death [24]. The findings of the 5-year outcomes of this clinical trial
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