Outcome of Acute Ischemic Stroke after the Treatment with Edaravone and 0.6 Mg/Kg Alteplase in Japanese Patients with Diabetes

Background We investigated how diabetes mellitus (DM) affects the outcome of acute ischemic stroke (AIS), comparing with the outcomes in those who had hypertension (HT) and atrial fibrillation (AF). Methods This study was a sub-analysis of PROTECT4.5, which was previously performed as a large-scale, prospective observational study of edaravone with approximately 10,000 patients with AIS in Japan. The study patients treated with edaravone alone or edaravone + alteplase (recombinant tissue plasminogen activator [tPA]) were analyzed for their outcomes and explored for the risk factors of poor outcome, after being divided into 8 groups according to their affected complications of DM, HT, or AF in the groups treated with edaravone alone or edaravone + tPA. Results Among patients treated with edaravone alone and edaravone + tPA, the mean reduction in the National Institutes of Health Stroke Scale from baseline to 3 months after the onset was 2.0 and 4.4 in DM groups, respectively. The reduction was smaller in these groups compared with other groups (3.3-4.3 and 6.0-7.7, respectively). The logistic regression model revealed that DM was an independent risk factor for highly unfavorable outcome of modified Rankin Scale score 3-6 at 3 months after the onset, among both patients treated with edaravone alone and those treated with edaravone + tPA (odds ratio [OR]: 2.23, 95% confidential interval [CI]: 1.42-3.50 and OR: 2.05, 95% CI: 1.33-3.14, respectively). Conclusions DM is suggested to adversely affect the outcome of AIS in Japanese patients.