The Pharmaceutical Journal
Vol 276 No 7388 p197
18 February 2006

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New drug could reduce disability following stroke, researchers say

Free-radical-trapping agent NXY-059 has shown benefits in reducing disability in stroke patients (New England Journal of Medicine 2006;354:588).

Kennedy Lees, of the acute stroke unit and cerebrovascular clinic, Western Infirmary, Glasgow, and colleagues conducted a randomised, double blind, placebo-controlled trial involving 1,722 patients with acute ischaemic stroke. Patients received a 72-hour intravenous infusion of NXY-059 or placebo within six hours of the onset of stroke. Alteplase treatment was given to 28.7 per cent of patients. The primary outcome measure was level of disability at 90 days as measured by the modified Rankin scale (0 = no residual symptoms; 5 = bedbound).

NXY-059 (Cerovive), under development by AstraZeneca, reduces the size of the infarct and preserves brain functioning in animal models of acute ischaemic stroke.

Patients in the NXY-059 group showed a reduction in disability at 90 days compared with those in the placebo group (P=0.038). Researchers calculated that the odds for avoiding disability were about 20 per cent better in the NXY-059 group than in the placebo group. “This benefit was seen at both ends of the scale: 4.4 per cent more patients who received the study drug became asymptomatic and 3.7 per cent more were able to walk without help, as compared with those in the placebo group,” say the researchers.

Survival and the incidence of adverse events were similar in the two groups. The researchers found no significant interaction between NXY-059 and stroke severity, treatment with alteplase, or time from onset of stroke to treatment “indicating that the treatment benefit is present irrespective of these factors”. A post-hoc analysis revealed that in those who also received alteplase, NXY-059 was associated with a lower incidence of haemorrhagic transformation and symptomatic intracranial haemorrhage.

Secondary outcomes of neurological functioning were not significantly improved with NXY-059 and the researchers say that a considerably larger, confirmatory study is required to determine whether it has a benefit in stroke.