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| Neuroprotective agent improves outcome after ischaemic stroke |
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09 February 2006
The first neuroprotective agent to show positive results in a phase 3 trial significantly reduces disability after ischaemic stroke, according to results of the Stroke-Acute Ischemic NXY Treatment (SAINT I) trial published in the February 9, 2006 issue of The New England Journal of Medicine.
The administration of NXY-059 within six hours after the onset of acute ischaemic stroke significantly improved the primary outcome (reduced disability at 90 days), but it did not significantly improve other outcome measures, including neurologic functioning as measured by the NIHSS score. Additional research is needed to confirm whether NXY-059 is beneficial in ischaemic stroke. Dr Grotta said that SAINT II, involving 3,200 patients, is ongoing to confirm the SAINT I results. Results of SAINT II are expected in 2007. "If the results are positive, then we can expect FDA approval," Dr Grotta remarked.
Editorialist Dr Gregory del Zoppo cautions that while promising, the results with NXY-059 might not yield a significant benefit in the bigger picture of ischaemic stroke. He writes "effective strategies for ischaemic stroke may need to provide protection to the entire neurovascular unit," rather than reducing neuronal cell damage alone.
Reference:
N Engl J Med 2006; 354 (6): 588-600.
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