Safety and efficacy of 0.6 mg/kg rt-PA: optimum rt-PA dose revisited.
Author(s): Mori E.
Affiliation(s): Department of Behavioral Neurology and Cognitive Neuroscience, Tohoku University
Graduate School of Medicine, Sendai, Japan. morie@med.tohoku.ac.jp
Publication date & source: 2012, Ann N Y Acad Sci. , 1268:108-12
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.
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