| Autor: |
Guekht A; Moscow Research and Clinical Center for Neuropsychiatry and Russian National Research Medical University, Moscow, Russia., Vester J; Department of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Krailling, Germany., Heiss WD; Max Planck Institute for Metabolism Research, Cologne, Germany., Gusev E; Department of Neurology, Neurosurgery and Medical Genetics, Pirogov Russian National Research Medical University, Moscow, Russia., Hoemberg V; Department of Neurology, SHR Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany., Rahlfs VW; Department of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Krailling, Germany., Bajenaru O; Department of Neurology, 'Carol Davila' University of Medicine and Pharmacy, Bucharest, Romania., Popescu BO; Department of Neurology, 'Carol Davila' University of Medicine and Pharmacy, Bucharest, Romania.; Laboratory of Molecular Biology, 'Victor Babes' National Institute of Pathology, Bucharest, Romania., Doppler E; Department of Clinical Research, EVER Neuro Pharma GmbH, Unterach, Austria., Winter S; Department of Clinical Research, EVER Neuro Pharma GmbH, Unterach, Austria., Moessler H; COMAMO LifeSciences GmbH, Mondsee, Austria., Muresanu D; Department of Clinical Neurosciences, 'Iuliu Hatieganu' University of Medicine and Pharmacy, Victor Babes Street No. 8, 400012, Cluj-Napoca, Romania. dafinm@ssnn.ro.; 'RoNeuro' Institute for Neurological Research and Diagnostic, Strada Mircea Eliade 37, 400000, Cluj-Napoca, Romania. dafinm@ssnn.ro. |
| Abstrakt: |
This meta-analysis combines the results of two identical stroke studies (CARS-1 and CARS-2) assessing efficacy of Cerebrolysin on motor recovery during early rehabilitation. Cerebrolysin is a parenterally administered neuropeptide preparation approved for the treatment of stroke. Both studies had a prospective, randomized, double-blind, placebo-controlled design. Treatment with 30 ml Cerebrolysin once daily for 3 weeks was started 24-72 h after stroke onset. In addition, patients participated in a standardized rehabilitation program for 21 days that was initiated within 72 h after stroke onset. For both studies, the original analysis data were used for meta-analysis (individual patient data analysis). The combination of these two studies by meta-analytic procedures was pre-planned, and the methods were pre-defined under blinded conditions. The nonparametric Mann-Whitney (MW) effect size of the two studies on the ARAT score on day 90 indicated superiority of Cerebrolysin compared with placebo (MW 0.62, P < 0.0001, Wei-Lachin pooling procedure, day 90, last observation carried forward; N = 442). Also, analysis of early benefit at day 14 and day 21 by means of the National Institutes of Health Stroke Scale, which is regarded as most sensitive to early improvements, showed statistical significance (MW 0.59, P < 0.002). The corresponding number-needed-to-treat (NNT) for clinically relevant changes in early NIHSS was 7.1 (95% CI: 4 to 22). Cerebrolysin had a beneficial effect on motor function and neurological status in early rehabilitation patients after acute ischemic stroke. Safety aspects were comparable to placebo, showing a favourable benefit/risk ratio. |
