Effect of Edaravone on Neurological Symptoms in Real-World Patients With Acute Ischemic Stroke

Abstract

Background and Purpose— In Japan, nearly half of ischemic stroke patients receive edaravone for acute treatment. The purpose of this study was to assess the effect of edaravone on neurological symptoms in patients with ischemic stroke stratified by stroke subtype. Methods— Study subjects were 61 048 patients aged 18 years or older who were hospitalized ≤14 days after onset of an acute ischemic stroke and were registered in the Japan Stroke Data Bank, a hospital-based multicenter stroke registration database, between June 2001 and July 2013. Patients were stratified according to ischemic stroke subtype (large-artery atherosclerosis, cardioembolism, small-vessel occlusion, and cryptogenic/undetermined) and then divided into 2 groups (edaravone-treated and no edaravone). Neurological symptoms were evaluated using the National Institutes of Health Stroke Scale (NIHSS). The primary outcome was changed in neurological symptoms during the hospital stay (ΔNIHSS=NIHSS score at discharge−NIHSS score at admission). Data were analyzed using multivariate linear regression with inverse probability of treatment weighting after adjusting for the following confounding factors: age, gender, and systolic and diastolic blood pressure at the start of treatment, NIHSS score at admission, time from stroke onset to hospital admission, infarct size, comorbidities, concomitant medication, clinical department, history of smoking, alcohol consumption, and history of stroke. Results— After adjusting for potential confounders, the improvement in NIHSS score from admission to discharge was greater in the edaravone-treated group than in the no edaravone group for all ischemic stroke subtypes (mean [95% CI] difference in ΔNIHSS: −0.46 [−0.75 to −0.16] for large-artery atherosclerosis, −0.64 [−1.09 to −0.2] for cardioembolism, and −0.25 [−0.4 to −0.09] for small-vessel occlusion). Conclusions— For any ischemic stroke subtype, edaravone use (compared with no use) was associated with a greater improvement in neurological symptoms, although the difference was small (<1 point NIHSS) and of limited clinical significance.

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“…For cerebral ischemia, edaravone, which has limited clinical significance for acute ischemic stroke [36], was associated with a trend toward reduced poor outcomes caused by cerebral vasospasm after aSAH [14]. Notably, the mean ages of participants in these previous studies ranged from 53-62 years [14,34,[8][9][10][11][12][13], which is similar to the mean age of the non-elderly group in the present study (57 years).…”

Edaravone Therapy Could be a Substitute for Decompressive Craniotomy/Craniectomy for Large Ischemic Stroke in Remote Areas with no Neurosurgeons

“…Similarly, on discharge, they observed that, the NIHSS scores were lower in the edaravone-treated group than in the no edaravone group. They concluded that edaravone use correlated well with improvement of neurological deficits using the NIHSS [6] .…”

“…Kobayashi et al using the Japan Stroke Data Bank, conducted a study on the impact of edaravone on neurological deficits in acute ischemic stroke patients [6] . The patients were stratified into ischemic stroke subtype such as large-artery atherosclerosis, cardioembolism, and small-vessel occlusion.…”

“…In their study, they observed that an NIHSS score of ≥ 4 was cogitated as clinically significant improvement in neu-2 ABCMED 9(1):1-3 rological deficits [4,6] . They detected that, the impact of edaravone was utmost in stroke victims with severe disability.…”

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“…Furthermore, rt-PA appears to be associated with relative increases of intracranial hemorrhagic complications [7,8]. Edaravone, a potent free radical scavenger, approved in Japan in 2001 for the treatment of acute ischemic stroke, has also been used in China and other Asian countries, and it has been shown to improve neurological deficits, but it has not been widely used worldwide [9]. Other than pharmacological therapy, in-hospital stroke unit care with multidisciplinary teams has been shown to reduce mortality, dependency, and poor functional outcomes [10].…”