Research Reports - Study evaluating the effects of Cerebrolysin treatment on clinical outcomes in traumatic brain injury

CNS Neurol Disord Drug Targets. 2015 Apr 30

Muresanu DF(1), Ciurea AV, Gorgan RM, Gheorghita E, Florian S, Stan H, Blaga A,
Ianovici N, Iencean SM, Turliuc D, Davidescu HB, Mihalache C, Brehar FM, Mihăescu
AS, Mardare DC, Anghelescu A, Chiparus C, Lapadat M, Pruna V, Mohan D, Costea C,
Costea D, Palade C, Bucur N, Figueroa J, Alvarez A.

Traumatic brain injury (TBI) is a leading cause of death and disability for which
there is currently no effective drug therapy available. Because drugs targeting a
single TBI pathological pathway have failed to show clinical efficacy to date,
pleiotropic agents with effects on multiple mechanisms of secondary brain damage
could represent an effective option to improve brain recovery and clinical
outcome in TBI patients. In this multicenter retrospective study, we investigated
severity-related efficacy and safety of the add-on therapy with two
concentrations (20 ml/day or 30 ml/day) of Cerebrolysin (EVER Neuro Pharma,
Austria) in TBI patients. Adjunctive treatment with Cerrebrolysin started within
48 hours after TBI and clinical outcomes were ranked according to the Glasgow
Outcome Scale and the Modified Rankin Disability Score at 10 and 30 days
post-TBI. Analyses of efficacy were performed separately for subgroups of
patients with mild, moderate or severe TBI according to Glasgow Coma Scale scores
at admission. Compared to standard medical care alone (control group), both doses
of Cerebrolysin were associated with improved clinical outcome scores at 10 days
post-TBI in mild patients and at 10 and 30 days in moderate and severe cases. A
dose-dependent effect of Cerebrolysin on TBI recovery was supported by the
dose-related differences and the significant correlations with treatment duration
observed for outcome measures. The safety and tolerability of Cerebrolysin in TBI
patients was very good. In conclusion, the results of this large retrospective
study revealed that early Cerebrolysin treatment is safe and is associated to
improved TBI outcome.

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