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2018 ; 39
(4
): 629-640
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Safety and efficacy of Cerebrolysin in early post-stroke recovery: a
meta-analysis of nine randomized clinical trials
#MMPMID29248999
Bornstein NM
; Guekht A
; Vester J
; Heiss WD
; Gusev E
; Hömberg V
; Rahlfs VW
; Bajenaru O
; Popescu BO
; Muresanu D
Neurol Sci
2018[Apr]; 39
(4
): 629-640
PMID29248999
show ga
This meta-analysis combines the results of nine ischemic stroke trials, assessing
efficacy of Cerebrolysin on global neurological improvement during early
post-stroke period. Cerebrolysin is a parenterally administered neuropeptide
preparation approved for treatment of stroke. All included studies had a
prospective, randomized, double-blind, placebo-controlled design. The patients
were treated with 30-50 ml Cerebrolysin once daily for 10-21 days, with treatment
initiation within 72 h after onset of ischemic stroke. For five studies, original
analysis data were available for meta-analysis (individual patient data
analysis); for four studies, aggregate data were used. The combination by
meta-analytic procedures was pre-planned and the methods of synthesis were
pre-defined under blinded conditions. Search deadline for the present
meta-analysis was December 31, 2016. The nonparametric Mann-Whitney (MW) effect
size for National Institutes of Health Stroke Scale (NIHSS) on day 30 (or 21),
combining the results of nine randomized, controlled trials by means of the
robust Wei-Lachin pooling procedure (maximin-efficient robust test), indicated
superiority of Cerebrolysin as compared with placebo (MW 0.60, P?0.0001,
N?=?1879). The combined number needed to treat for clinically relevant changes in
early NIHSS was 7.7 (95% CI 5.2 to 15.0). The additional full-scale ordinal
analysis of modified Rankin Scale at day 90 in moderate to severe patients
resulted in MW 0.61 with statistical significance in favor of Cerebrolysin (95%
CI 0.52 to 0.69, P?=?0.0118, N?=?314). Safety aspects were comparable to placebo.
Our meta-analysis confirms previous evidence that Cerebrolysin has a beneficial
effect on early global neurological deficits in patients with acute ischemic
stroke.