Preliminary data show improved reperfusion, significant clinical improvements in select patients
WEDNESDAY, March 21 (HealthDay News) -- Tenecteplase is superior to alteplase for the treatment of acute ischemic stroke for select patients, according to a study published in the March 22 issue of the New England Journal of Medicine.
Mark Parsons, M.D., of the University of Newcastle in Australia, and colleagues conducted a phase 2B trial in which patients were randomized to receive alteplase (0.9 mg/kg) or tenecteplase (0.1 or 0.25 mg/kg) less than six hours after the onset of ischemic stroke. The eligibility criteria of a perfusion lesion at least 20 percent greater than the infarct core on baseline computed tomography (CT) perfusion imaging, and an associated vessel occlusion on CT angiography, favored selection of patients most likely to benefit from thrombolytic therapy.
The researchers found that, at baseline, the mean National Institutes of Health Stroke Scale score for all patients was 14.4 ± 2.6, and the time to treatment was 2.9 ± 0.8 hours. At 24 hours, significantly greater reperfusion and clinical improvement were seen in the two tenecteplase groups compared with the alteplase group. There were no significant differences in intracranial bleeding or other serious adverse events between the groups. For all efficacy outcomes, including absence of serious disability at 90 days, the higher dose of tenecteplase was significantly superior to the lower dose and to alteplase (72 percent of patients in the higher-dose group versus 40 percent in the alteplase group; P = 0.02).
"Tenecteplase was associated with significantly better reperfusion and clinical outcomes than alteplase in patients with stroke," the authors write.
Several authors disclosed financial ties to the pharmaceutical industry.
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