http://stroke.ahajournals.org/content/early/2017/04/21/STROKEAHA.116.014321?
(A Randomized Trial of Efficacy, 12 Months International Double-Blind Actovegin)
Abstract
Background and Purpose—Poststroke
cognitive impairment is a debilitating consequence of stroke. The aim
of this study was to assess whether Actovegin confers cognitive benefit
in patients who have had an ischemic stroke.
Methods—This
was a 12-month, parallel-group, randomized, multicenter, double-blind,
placebo-controlled study. Eligible patients were ≥60 years of age with a
Montreal Cognitive Assessment test score of ≤25 points. Patients were
randomized into 2 groups within 1 week of acute supratentorial ischemic
stroke in a 1:1 ratio: Actovegin (a deproteinized hemoderivative of calf
blood, 2000 mg/d for ≤20 intravenous infusions followed by 1200 mg/d
orally) or placebo for 6 months. Patients were treated in accordance
with standard clinical practice for a further 6 months. The primary end
point was the change from baseline in Alzheimer’s Disease Assessment
Scale, cognitive subscale, extended version at 6 months.
Results—Two-hundred
forty-eight patients were randomized to Actovegin and 255 patients to
placebo. At month 6, the least squares mean change from baseline in
Alzheimer’s Disease Assessment Scale, cognitive subscale, extended
version was −6.8 for Actovegin and −4.6 for placebo; the estimated
treatment difference was −2.3 (95% confidence interval, −3.9, −0.7; P=0.005).
Recurrent ischemic stroke was the most frequently reported serious
adverse event, with a nonsignificantly higher number for Actovegin
versus placebo.
Conclusions—Actovegin
had a beneficial effect on cognitive outcomes in patients with
poststroke cognitive impairment. The safety experience was consistent
with the known safety and tolerability profile of the drug. These
results warrant confirmation in additional robustly designed studies.
Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01582854.
No comments:
Post a Comment