Clinical Efficacy of Cerebrolysin and Cerebrolysin plus Nootropics in the Treatment of Patients with Acute Ischemic Stroke in Vietnam
Overview
Abstract:
Aims: To
investigate the efficacy and safety of Cerebrolysin and Cerebrolysin plus
nootropics in the routine treatment of patients with acute ischemic stroke
(AIS).
Background: Acute ischemic stroke (AIS) is a leading cause of disability with
unmet treatment needs lacking effective drug therapy. Multimodal drugs
modulating stroke pathophysiology as Cerebrolysin constitute a good therapeutic
option.
Objective: In this study, we assessed the effects of Cerebrolysin and
Cerebrolysin plus nootropics, in comparison with other nootropic drugs alone,
on functional, neurological and cognitive recovery of patients with AIS in
Vietnam.
Methods: This
non-interventional, controlled, open-label, prospective and multicenter study
included 398 AIS patients (234 males) treated with Cerebrolysin (n=190; 20 i.v.
infusions of 10 ml), other nootropics (comparator group; n=86), or a
combination of both (n=122). The study primary endpoint was a modified Ranking
Scale (mRS) score on day 90. Secondary endpoints included study-period change
in NIHSS score; percentage of well-recovered (mRS 0-2) patients, the proportion
of good NIHSS response (≥6 points) cases, and MoCA scores at day 90; and safety
indicators.
Results: Compared
with other nootropics, both Cerebrolysin and combined therapy induced
significant improvements (p<0.001) in: Functional recovery (mRS scores);
percentage of well-recovered patients (Cerebrolysin: 81.6%; combination: 93.4%;
comparator: 43.0%); neurological recovery (study-period NIHSS change);
proportion of good NIHSS responders (Cerebrolysin: 77.5%; combination: 92.5%;
comparator: 47.6%); and MoCA scores (Cerebrolysin: 23.3±4.8; combination:
23.7±4.1; comparator: 15.9±7.7). Compared to Cerebrolysin, combined therapy
improved (p<0.01) mRS outcomes and NIHSS change, but not MoCA scores, in
moderate-severe stroke (NIHSS>11) cases only. No drug-related adverse events
were reported.
Conclusion: Cerebrolysin alone or combined with other nootropics was effective
and safe in routine AIS treatment, during both acute and recovery phases, which
supports its use in daily clinical practice. Other. According to the results of
this multicenter study, the importance of reducing differences in the treatment
regimens of AIS in Vietnam should be further emphasized.
Keyword(s): Keywords: Acute ischemic stroke; Cerebrolysin; combined therapy; multicenter; non-interventional; nootropics.
Journal | CNS & Neurological Disorders - Drug Targets |
Publication status | Published - Aug-2021 |
ISBN | 1871-5273 |