BACKGROUND AND PURPOSE: In Japan, alteplase at 0.6 mg/kg was approved in October 2005 for use within 3 hours of stroke onset by the Ministry of Health, Labor and Welfare (MHLW). The aim of the Japan post-Marketing Alteplase Registration Study (J-MARS), which was requested by MHLW at the time of approval, was to assess the safety and efficacy of 0.6 mg/kg alteplase in routine clinical practice for the Japanese. METHODS: A total of 7492 patients from 942 centers were enrolled in the J-MARS, an open-label, nonrandomized, observational study, from October 2005 to October 2007. Primary outcome measures were symptomatic intracranial hemorrhage (a deterioration in NIHSS score >or=4 from baseline) and favorable outcome (modified Rankin Scale score, 0-1) at 3 months after stroke onset. RESULTS: The proportion of patients with symptomatic intracranial hemorrhage in 7492 patients (safety analysis) was 3.5% (95% confidence interval [CI], 3.1%-3.9%) within 36 hours and 4.4% (95% CI, 3.9%-4.9%) at 3 months. The overall mortality rate was 13.1% (95% CI, 12.4%-13.9%) and the proportion of patients with fatal symptomatic intracranial hemorrhage was 0.9% (95% CI, 0.7%-1.2%). The outcomes at 3 months were available for 4944 patients and the proportion of favorable outcome (efficacy analysis) was 33.1% (95% CI, 31.8%-34.4%). The subgroup analysis in patients between 18 and 80 years with a baseline NIHSS score <25 demonstrated that favorable outcome at 3 months was 39.0% (95% CI, 37.4%-40.6%). CONCLUSIONS: These data suggest that 0.6 mg/kg intravenous alteplase within 3 hours of stroke onset could be safe and effective in routine clinical practice for the Japanese.
BACKGROUND AND PURPOSE: In Japan, alteplase at 0.6 mg/kg was approved in October 2005 for use within 3 hours of stroke onset by the Ministry of Health, Labor and Welfare (MHLW). The aim of the Japan post-Marketing Alteplase Registration Study (J-MARS), which was requested by MHLW at the time of approval, was to assess the safety and efficacy of 0.6 mg/kg alteplase in routine clinical practice for the Japanese. METHODS: A total of 7492 patients from 942 centers were enrolled in the J-MARS, an open-label, nonrandomized, observational study, from October 2005 to October 2007. Primary outcome measures were symptomatic intracranial hemorrhage (a deterioration in NIHSS score >or=4 from baseline) and favorable outcome (modified Rankin Scale score, 0-1) at 3 months after stroke onset. RESULTS: The proportion of patients with symptomatic intracranial hemorrhage in 7492 patients (safety analysis) was 3.5% (95% confidence interval [CI], 3.1%-3.9%) within 36 hours and 4.4% (95% CI, 3.9%-4.9%) at 3 months. The overall mortality rate was 13.1% (95% CI, 12.4%-13.9%) and the proportion of patients with fatal symptomatic intracranial hemorrhage was 0.9% (95% CI, 0.7%-1.2%). The outcomes at 3 months were available for 4944 patients and the proportion of favorable outcome (efficacy analysis) was 33.1% (95% CI, 31.8%-34.4%). The subgroup analysis in patients between 18 and 80 years with a baseline NIHSS score <25 demonstrated that favorable outcome at 3 months was 39.0% (95% CI, 37.4%-40.6%). CONCLUSIONS: These data suggest that 0.6 mg/kg intravenous alteplase within 3 hours of stroke onset could be safe and effective in routine clinical practice for the Japanese.
Authors: Geoffrey A Donnan; Stephen M Davis; Mark W Parsons; Henry Ma; Helen M Dewey; David W Howells Journal: Nat Rev Neurol Date: 2011-06-14 Impact factor: 42.937
Authors: N Dequatre-Ponchelle; H Touzani; A Banh; I Girard-Buttaz; R Coche; P Dobbelaere; C Cordonnier; M Girot; P Aguettaz; F Mounier-Vehier; E Wiel; N Bronet; E Josien; P Duhamel; M Mihout; A Maisonneuve; A Mackowiak; M Bodenant; P Williatte; X Leclerc; C Lefebvre; O Nigeon; P Devos; G Duncan; G Malanda; B Majed; O Dereeper; V Pégoraro; T Rosolacci; P Alarcon; E Koral; M Pasquini; S Verclytte; J B N'Kuendjo; J B Campagne; P Le Coz; J Devienne; Z Seth; R Tholliez; H Hénon; G Smith; F Dumont; F Agbemebia; J M Behra; D Pollet; P Coffin; P Lavau; A Vérier; C Lucas; N Smaiti; P Dalinval; J Dallongeville; P Valette; J P Pruvo; P Goldstein; D Leys Journal: J Neurol Date: 2014-04-22 Impact factor: 4.849
Authors: Mei-Ling Sharon Tai; Khean Jin Goh; Khairul Azmi Abdul Kadir; Mohd Idzwan Zakaria; Jun Fai Yap; Kay Sin Tan Journal: Singapore Med J Date: 2018-11-29 Impact factor: 1.858