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Randomized trial of Cervene, a kappa receptor-selective opioid antagonist, in acute ischemic stroke.
MedLine Citation:
PMID:  17894963     Owner:  NLM     Status:  PubMed-not-MEDLINE    
Abstract/OtherAbstract:
The purpose of this randomized trial was to confirm drug safety and to obtain preliminary efficacy data on Cervene (nalmefene), an opioid antagonist with relative kappa receptor selectivity, for the treatment of acute ischemic stroke. Patients were treated for 24 hours with either intravenous Cervene (0.05 mg/kg as an initial infusion over 15 minutes and 0.01 mg/kg/h maintenance) or placebo within 6 hours of an ischemic stroke. Efficacy was assessed by comparing the change from baseline to day 7 in the National Institutes of Health stroke scale score (NIHSSS) and the Glasgow Outcome Scale and Barthel Index at 3 months. Forty-four evaluable patients were randomized (3:1) to Cervene (n = 34; treated at 5.0 +/- 0.9 hours after onset) and placebo (n = 10; treated at 4.6 +/- 1.5 hours). No deaths or serious adverse events reasonably attributable to Cervene have been reported. A "major improvement" (NHSSS > 4) was seen at day 7: placebo, 33% (three of nine patients) and Cervene, 66% (19 of 29 patients). Only patients with initial NIHSSS >/= 4 were considered evaluable for this primary endpoint. "Good recovery" at 3 months (Glasgow = 5) was as follows: placebo, 50% (5 of 10 patients) and Cervene, 73% (24 of 33 patients). The death rate at 3 months was placebo, 20% (2 of 10 patients) and Cervene, 9.1% (3 of 33 patients). One patient was lost to follow-up. In conclusion, results from this randomized trial suggest that Cervene is safe, tolerable, and may be beneficial in the treatment of acute stroke patients.
Authors:
W M Clark; B M Coull; M Karukin; B Hendin; R Kelley; H Rosing; S Zachariah; M Winograd; E Raps; T Walshe; S Singer; K L Mettinger
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association     Volume:  6     ISSN:  1052-3057     ISO Abbreviation:  J Stroke Cerebrovasc Dis     Publication Date:    1996 Sep-Oct
Date Detail:
Created Date:  2007-09-26     Completed Date:  2009-12-11     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9111633     Medline TA:  J Stroke Cerebrovasc Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  35-40     Citation Subset:  -    
Affiliation:
Oregon Stroke Center, Oregon Health Sciences University, Portland, OR, USA.
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Comment In:
J Stroke Cerebrovasc Dis. 1996 Sep-Oct;6(1):3-4   [PMID:  17894957 ]

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