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Thomas Brott, MD

Arch Neurol. 1996;53(12):1305-1306.

	Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings.

ON JUNE 6,1996, the Peripheral and Central Nervous System Drug Advisory Committee to the US Food and Drug Administration (FDA) voted 10 to 0 that tissue-type plasminogen activator (t-PA [lateplase]) is safe and effective therapy for acute ischemic stroke.¹ The focus of the committee was on part 2 of the National Institute of Neurological Disorders and Stroke (NINDS) t-PA Stroke Study² as the pivotal efficacy study and on part 1 as the supportive study.

Why was the panel unanimous in judging t-PA as effective? In part 2 of the NINDS t-PA Stroke Study,² patients treated with 0.9-mg/kg t-PA intravenously within 3 hours of symptom onset were more likely to have minimal or no disability at 3 months compared with patients treated with placebo. Efficacy was consistent over 4 assessment scales. The relative advantage of t-PA ranged from 32% to 55%. A global statistic, combining results from the . . . [Full Text PDF of this Article]

Author Affiliations
From the Department of Neurology, University of Cincinnati, Cincinnati, Ohio.

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