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
Brott T. Thrombolysis for Stroke. Arch Neurol. 1996;53(12):1305–1306. doi:10.1001/archneur.1996.00550120117025