TY - JOUR
T1 - Thrombolysis with 0.6 mg/kg intravenous alteplase for acute ischemic stroke in routine clinical practice
T2 - The Japan post-Marketing Alteplase Registration Study (J-MARS)
AU - Nakagawara, Jyoji
AU - Minematsu, Kazuo
AU - Okada, Yasushi
AU - Tanahashi, Norio
AU - Nagahiro, Shinji
AU - Mori, Etsuro
AU - Shinohara, Yukito
AU - Yamaguchi, Takenori
PY - 2010/9
Y1 - 2010/9
N2 - 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 ≥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.
AB - 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 ≥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.
KW - acute ischemic stroke
KW - alteplase
KW - postmarketing registration
KW - thrombolysis
KW - tissue plasminogen activator
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U2 - 10.1161/STROKEAHA.110.589606
DO - 10.1161/STROKEAHA.110.589606
M3 - Article
C2 - 20651262
AN - SCOPUS:77956410175
VL - 41
SP - 1984
EP - 1989
JO - Stroke
JF - Stroke
SN - 0039-2499
IS - 9
ER -