At the time of approval of alteplase for treatment of acute ischemic stroke by MHLW, they required the companies 1) to present results of post-marketing efficacy and safety survey on 3,000 cases or more within 2 years, and 2) to confirm if i.v. dose of 0.6 mg/kg alteplase can recanalize or reopen the occluded artery.
During the period of October, 2005 and September, 2006, the number of patients treated with alteplase was estimated to be 3,200.
Among 2,867 patients registered to the post-marketing survey, data sheets were obtained from 2,069. These data were used for analysis of patients' characteristics and adverse effects.
Symptomatic intracranial hemorrhage (sICH) within 36 hours was seen in 4.7%, slightly less than those of J-ACT, 5.8%. Death due to sICH was the same as those in J-ACT (1.0% each).
Total efficacy rate of the post-marketing survey, mRS 0 & 1 at 3 months, was 32.7%, slightly worse than those of J-ACT, 36.9%. But, it was apparently better than historical observational data from JSSRS and J-MUSIC.
These results may be explained by the fact that 121 patients (10%) with age ≥75 years and NIHSS score ≥23/JCS ≥100 were included. Proportion of favorable outcome in those 121 patients was only 6.0%, while those in 1,266 patients without such conditions were 37.0%. Mortality in each group was 42% and 16%, respectively. The above results suggest that we have to ask physicians/surgeons to keep the treatment guidelines more strictly (to avoid those patients with older age and high NIHSS score).