Abstract
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.
Keywords: Cerebrolysin, disability, functional recovery, neuroprotection, clinical outcome, traumatic brain injury.
CNS & Neurological Disorders - Drug Targets
Title:A Retrospective, Multi-Center Cohort Study Evaluating the Severity- Related Effects of Cerebrolysin Treatment on Clinical Outcomes in Traumatic Brain Injury
Volume: 14 Issue: 5
Author(s): Anca . S. Mihăescu, Anton Alvarez, Jesus Figueroa, Narcisa Bucur, Claudiu Palade, Daniel Costea, Constantin Costea, Dumitru Mohan, Viorel Pruna, Magdalena Lapadat, Carmen Chiparus, Aurelian Anghelescu, Dinu C. Mardare, Dafin F. Muresanu, Felix M. Brehar, Cornel Mihalache, Horia B. Davidescu, Dana Turliuc, Stefan M. Iencean, Nicolai Ianovici, Alin Blaga, Horatiu Stan, Stefan I. Florian, Eva Gheorghita, Radu M. Gorgan and Alexandru V. Ciurea
Affiliation:
Keywords: Cerebrolysin, disability, functional recovery, neuroprotection, clinical outcome, traumatic brain injury.
Abstract: 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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Cite this article as:
S. Mihăescu Anca ., Alvarez Anton, Figueroa Jesus, Bucur Narcisa, Palade Claudiu, Costea Daniel, Costea Constantin, Mohan Dumitru, Pruna Viorel, Lapadat Magdalena, Chiparus Carmen, Anghelescu Aurelian, C. Mardare Dinu, Muresanu Dafin F., M. Brehar Felix, Mihalache Cornel, Davidescu Horia B., Turliuc Dana, M. Iencean Stefan, Ianovici Nicolai, Blaga Alin, Stan Horatiu, I. Florian Stefan, Gheorghita Eva, M. Gorgan Radu and V. Ciurea Alexandru, A Retrospective, Multi-Center Cohort Study Evaluating the Severity- Related Effects of Cerebrolysin Treatment on Clinical Outcomes in Traumatic Brain Injury, CNS & Neurological Disorders - Drug Targets 2015; 14 (5) . https://dx.doi.org/10.2174/1871527314666150430162531
DOI https://dx.doi.org/10.2174/1871527314666150430162531 |
Print ISSN 1871-5273 |
Publisher Name Bentham Science Publisher |
Online ISSN 1996-3181 |
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