2008
DOI: 10.1161/strokeaha.107.503334
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NXY-059 for the Treatment of Acute Stroke

Abstract: Background and Purpose-In animal models of acute ischemic stroke (AIS), the free radical-trapping agent showed promise as a neuroprotectant. SAINT I and II were randomized, placebo-controlled, double-blind trials to investigate the efficacy of NXY-059 in patients with AIS. Methods-Patients with AIS received an infusion of intravenous NXY-059 or placebo within 6 hours from the onset of stroke symptoms. A pooled individual patient analysis was prespecified to assess the overall efficacy and to examine subgroups… Show more

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Cited by 224 publications
(86 citation statements)
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“…In the only other IAD meta-analysis performed to date, NXY-059 was found to reduce stroke lesion volume but it failed to be effective in clinical trial. 23,39,40 Our results, and previous experience in experimental stroke and clinical trials, suggest that it may be beneficial for preclinical studies to be analyzed rigorously, including performing IAD meta-analysis, before clinical trials are initiated.…”
Section: Discussionmentioning
confidence: 79%
“…In the only other IAD meta-analysis performed to date, NXY-059 was found to reduce stroke lesion volume but it failed to be effective in clinical trial. 23,39,40 Our results, and previous experience in experimental stroke and clinical trials, suggest that it may be beneficial for preclinical studies to be analyzed rigorously, including performing IAD meta-analysis, before clinical trials are initiated.…”
Section: Discussionmentioning
confidence: 79%
“…Infarct size has traditionally been measured with 2,3,5-triphenyltetra-zolium chloride, hematoxylin-eosin, or nissl-stained brain sections, though the increasing availability of MRI in the experimental research environment has started to produce studies in which T 2 -weighted imaging has been used to estimate final infarct size (Ashioti et al, 2007;Farr et al, 2007;Palmer et al, 2001). Infarct sizes assessed by T 2 -weighted imaging have been shown to correlate well by some (Palmer et al, 2001) (Davis et al, 2000), sodium or calcium channel blockers (for example, Lubeluzole: Lubeluzole in Ischemic Stroke) , or the recently highly publicized free radical scavenger Cerovive: Stroke Acute Ischemic NXY-059 Treatment (SAINT I and II) (Diener et al, 2008). It is therefore likely that the criterion of infarct size alone is insufficient to be used as a sole outcome surrogate.…”
Section: Infarct Sizementioning
confidence: 99%
“…Similar shortcomings apply to cell culture systems in which O 2 -, along with other reactive oxygen species (ROS), are generated by the addition of chemical agents (84,101), enzymatically (xanthine plus xanthine oxidase) (84), by radiation exposure (110); by activation of macrophages (33), and so on. The lack of a clear understanding of both the nature of the ROS responsible for damage and the mechanisms of action of the tested compounds can be listed among the reasons for failures in clinical trials (8,23,38,44,52,76,109). The use of so-called ''SOD mimics'' with low superoxide-scavenging activity casts doubt on mechanistic studies in which such compounds are applied ''to prove'' O 2 -involvement.…”
mentioning
confidence: 99%