title: Tolerability and efficacy of erythropoietin (EPO) treatment in traumatic spinal cord injury: a preliminary randomized comparative trial vs. methylprednisolone (MP).
abstract: The only available treatment of traumatic spinal cord injury (TSCI) is high-dose methylprednisolone (MP) administered acutely after injury. However, as the efficacy of MP is controversial, we assessed the superiority of erythropoietin (EPO) versus MP in improving clinical outcome of acute TSCI. Patients aged 18 to 65 years after C5-T12 injury, and grade A or B of the ASIA Impairment Scale (AIS), admitted within 8 h, hemodynamically stable, were randomized to MP according to the NASCIS III protocol or EPO iv (500 UI/kg, repeated at 24 and 48 h). Patients were assessed by an investigator blind to treatment assignment at baseline and at day 3, 7, 14, 30, 60 and 90. Primary end point: number of responders (reduction of at least one AIS grade). Secondary end points: treatment safety and the effects of drugs on a number of disability measures. Frequentistic and post hoc Bayesian analyses were performed. Eight patients were randomized to MP and 11 to EPO. Three patients (27.3 %) on EPO and no patients on MP reached the primary end point (p = 0.17). No significant differences were found for the other disability measures. No adverse events or serious adverse events were reported in both groups. The Bayesian analysis detected a 91.8 % chance of achieving higher success rates on the primary end point with EPO in the intention-to-treat population with a 95 % chance the difference between EPO and MP falling in the range (-0.10, 0.51) and a median value of 0.2. The results of Bayesian analysis favored the experimental treatment.
authors.affiliation: Spinal Unit, Niguarda Ca' Granda Hospital, Milan, Italy.
authors.forename: Davide Dalla
authors.initials: DD
authors.lastname: Costa
authors.forename: Ettore
authors.initials: E
authors.lastname: Beghi
authors.forename: Paola
authors.initials: P
authors.lastname: Carignano
authors.forename: Cristina
authors.initials: C
authors.lastname: Pagliacci
authors.forename: Franco
authors.initials: F
authors.lastname: Faccioli
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Pupillo
authors.forename: Paolo
authors.initials: P
authors.lastname: Messina
authors.forename: Alfredo
authors.initials: A
authors.lastname: Gorio
authors.forename: Tiziana
authors.initials: T
authors.lastname: Redaelli
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001499:Bayes Theorem; D002574:Cervical Vertebrae; D003198:Computer Simulation; D004921:Erythropoietin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008775:Methylprednisolone / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016037:Single-Blind Method; D013119:Spinal Cord Injuries / Q000188:drug therapy*; D013904:Thoracic Vertebrae; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018696:Neuroprotective Agents; D004921:Erythropoietin; D008775:Methylprednisolone
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