Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke
Authors: Xu Jie , Wang Anxin , Meng Xia , Yalkun Gulbahram , Xu Anding , Gao Zhiqiang , Chen Huisheng , Ji Yong , Xu Jun , Geng Deqin , Zhu Runxiu , Liu Bo , Dong Aiqin , Mu Hua , Lu Zhihong , Li Shuya , Zheng Huaguang , Chen Xia , Wang Yilong , Zhao Xingquan , Wang Yongjun , Wang Yongjun , Xu Anding , Zhao Xingquan , Chen Xia , Wang Yongjun , Meng Xia , Wang Yilong , Xu Jie , Wang Anxin , Zheng Huaguang , Gao Zhiqiang , Duan Lei , Zhang Jinghua , Li Shuya , Lou Donghua , Gao Zhiqiang , Chen Huisheng , Ji Yong , Xu Jun , Geng Deqin , Zhu Runxiu , Liu Bo , Dong Aiqin , Liang Qingcheng , Yang Hong , Guo Cunju , Li Xin , He Mingli , Tian Xiangyang , Cui Yong , Zhou Junshan , Wang Ning , Wang Lei , Zhang Xinjiang , Gao Xiaoping , Lu Liping , Li Tong , Cheng Yan , Liu Kaixiang , Xi Xiaokun , Wang Baojun , Sun Lin , Zhao Shigang , Chu Xiaofan , Lian Yajun , Yan Fuling , Wang Xiaoshan , Wang Dong , Shao Bei , Jiao Jinsong , Wu Heng , Li Guanglai , Guo Libin , Wang Yongjun , Pan Suyue , Xu Anding , Li Heng , Zhuang Jianhua , Li Xin , Wu Jun , Wang Anxin , Lou Donghua , Zuo Yingting , Zhang Yijun , Zhang Xiaoli , Feng Xiaofei , Meng Xia , Wang David , Dong Kehui , Liu Yanfang , Li Hao , Chen Dawei , Lv Qiushi 
Published: February 2021

Background and Purpose:
Edaravone dexborneol, comprised of 2 active ingredients, edaravone and (+)-borneol, has been developed as a novel neuroprotective agent with synergistic effects of antioxidant and anti-inflammatory in animal models. The present clinical trial aimed at testing the effects of edaravone dexborneol versus edaravone on 90-day functional outcome in patients with acute ischemic stroke (AIS).

Methods:
A multicenter, randomized, double-blind, comparative, phase III clinical trial was conducted at 48 hospitals in China between May 2015 and December 2016. Inclusion criteria included patients diagnosed as AIS, 35 to 80 years of age, National Institutes of Health Stroke Scale Score between 4 and 24, and within 48 hours of AIS onset. AIS patients were randomized in 1:1 ratio into 2 treatment arms: 14-day infusion of edaravone dexborneol or edaravone injection. The primary end point was the proportion of patients with modified Rankin Scale score ≤1 on day 90 after randomization.

Results:

One thousand one hundred sixty-five AIS patients were randomly allocated to the edaravone dexborneol group (n=585) or the edaravone group (n=580). The edaravone dexborneol group showed significantly higher proportion of patients experiencing good functional outcomes on day 90 after randomization, compared with the edaravone group (modified Rankin Scale score ≤1, 67.18% versus 58.97%; odds ratio, 1.42 [95% CI, 1.12–1.81];
P
=0.004). The prespecified subgroup analyses indicated that a greater benefit was observed in female patients than their male counterparts (2.26, 1.49–3.43 versus 1.14, 0.85–1.52).

Conclusions:
When edaravone dexborneol versus edaravone was administered within 48 hours after AIS, 90-day good functional outcomes favored the edaravone dexborneol group, especially in female patients.

Registration:

URL:
https://www.clinicaltrials.gov
. Unique identifier: NCT02430350.