TY - JOUR

T1 - High-dose erythropoietin for tissue protection

AU - Lund, Anton

AU - Lundby, Carsten

AU - Olsen, Niels V

N1 - © 2014 Stichting European Society for Clinical Investigation Journal Foundation.

PY - 2014/12

Y1 - 2014/12

N2 - BACKGROUND: The discovery of potential anti-apoptotic and cytoprotective effects of recombinant human erythropoietin (rHuEPO) has led to clinical trials investigating the use of high-dose, short-term rHuEPO therapy for tissue protection in conditions such as stroke and myocardial infarction. Experimental studies have been favourable, but the clinical efficacy has yet to be validated.MATERIALS AND METHODS: We have reviewed clinical studies regarding the use of high-dose, short-term rHuEPO therapy for tissue protection in humans with the purpose to detail the safety and efficacy of rHuEPO for this indication. A systematic literature search was performed using the PubMed/MEDLINE database for randomized, placebo-controlled clinical trials.RESULTS: Twenty-six randomized controlled trials that enrolled 3176 patients were included. The majority of trials (20 trials including 2724 patients) reported no effect of rHuEPO therapy on measures of tissue protection. Five trials including 1025 patients reported safety concerns in the form of increased mortality or adverse event rates. No studies reported reduced mortality.CONCLUSIONS: Evidence is sparse to support a tissue-protective benefit of rHuEPO in humans. Moreover, a number of studies indicate that short-term administration of high-dose rHuEPO is associated with an increased risk of mortality and serious adverse events. Further work is needed to elucidate the mechanisms of toxicity of rHuEPO in humans.

AB - BACKGROUND: The discovery of potential anti-apoptotic and cytoprotective effects of recombinant human erythropoietin (rHuEPO) has led to clinical trials investigating the use of high-dose, short-term rHuEPO therapy for tissue protection in conditions such as stroke and myocardial infarction. Experimental studies have been favourable, but the clinical efficacy has yet to be validated.MATERIALS AND METHODS: We have reviewed clinical studies regarding the use of high-dose, short-term rHuEPO therapy for tissue protection in humans with the purpose to detail the safety and efficacy of rHuEPO for this indication. A systematic literature search was performed using the PubMed/MEDLINE database for randomized, placebo-controlled clinical trials.RESULTS: Twenty-six randomized controlled trials that enrolled 3176 patients were included. The majority of trials (20 trials including 2724 patients) reported no effect of rHuEPO therapy on measures of tissue protection. Five trials including 1025 patients reported safety concerns in the form of increased mortality or adverse event rates. No studies reported reduced mortality.CONCLUSIONS: Evidence is sparse to support a tissue-protective benefit of rHuEPO in humans. Moreover, a number of studies indicate that short-term administration of high-dose rHuEPO is associated with an increased risk of mortality and serious adverse events. Further work is needed to elucidate the mechanisms of toxicity of rHuEPO in humans.

U2 - 10.1111/eci.12357

DO - 10.1111/eci.12357

M3 - Journal article

VL - 44

SP - 1230

EP - 1238

JO - European Journal of Clinical Investigation

JF - European Journal of Clinical Investigation

SN - 0014-2972

IS - 12

ER -