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Safety and efficacy of 0.6 mg/kg rt‐PA: optimum rt‐PA dose revisited
Author(s) -
Mori Etsuro
Publication year - 2012
Publication title -
annals of the new york academy of sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.712
H-Index - 248
eISSN - 1749-6632
pISSN - 0077-8923
DOI - 10.1111/j.1749-6632.2012.06689.x
Subject(s) - medicine , clinical trial , thrombolysis , clinical efficacy , myocardial infarction
Although the internationally recommended dosage of alteplase, a single‐chain rt‐PA, is 0.9 mg/kg, 0.6 mg/kg is the only approved dosage in Japan, and it is widely used there. Duteplase is a two‐chain rt‐PA, and based on findings of the duteplase trials in the early 1990s, the smaller dosage of 0.6 mg/kg of alteplase was tested in the Japan Alteplase Clinical Trial (J‐ACT), which indicated that the efficacy/safety profile of this dose was comparable to the 0.9 mg/kg dosage used in other countries. The Japan Alteplase Clinical Trial II (J‐ACT II) further demonstrated efficacy of 0.6 mg/kg alteplase with regard to vascular outcomes in patients with middle cerebral artery (MCA) occlusion. Finally, the Japan post‐Marketing Alteplase Registration Study (J‐MARS) confirmed the efficacy/safety profile of 0.6 mg/kg alteplase in a clinical setting that was comparable to the dose of 0.9 mg/kg in the European counterpart, the Safe Implementation of Thrombolysis in Stroke‐Monitoring Study (SITS‐MOST). The dose of 0.6 mg/kg seems to be optimal, at least in far‐east Asians, and might be extrapolated to other ethnic groups as well.