2012/09/01 by Etsuro Mori · 1 citation
paper · doi:10.1111/j.1749-6632.2012.06689.x
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.