Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke
Authors: Zhang Qian , Wang Anxin , Xu Qin , Xia Xue , Tian Xue , Zhang Yijun , Li Xiaolong , Yang Xiusheng , Wang Xingchen , Peng Jinghua , Li Yanchun , Liu Luran , Jin Shunshan , Meng Xia , Zhao Xingquan ,   GDLM group, Wang Yongjun , He Maolin , Dong Qiang , Zhao Gang , Chen Kangning , Xie Peng , Xu Yun , Yang Yi , Guo Li , Li Yansheng , Wang Yilong , Zhang Xiaoli , Xu Anding , Pan Xudong , Xiao Cuilan , Wang David , Li Hao , Gao Ying , Xia Jielai , Zhao Hongjian , Wang Huijuan , He Yue , Li Weili , Wei Xiangyang , Bai Junqing , Cao Shiwei , Song Ying , Ma Zhanhu , Zhang Na , Yin Nianzhen , Zeng Long , Zhang Likun , Yang Fang , Zhang Jing , Wang Jian , Tang Huili , Li Yinghua , Zhou Hourong , Feng Haisong , Song Dongjing , Wang Jianyu , Ma Yongcui , Chen Lihui , Xiao Kaiwen , Zhai Qijin , Li Jing , Li Xiaojie , Yang Yinqiao , Mei Xue , Zhu Ziyun , Zhang Yan , Liu Yuhu , Nie Hongxia , Fu Bing , Huang Gang , Zeng Guoli , Liu Bingrong , Xiaomin Wang , Xu Lianying , Zhang Fan , Wang Lan , Han Wei , Meng Shanshan , Xiao Chang'e , Yang Zhijie , Deng Yanqing , Ying Hu , Tang Li , Jia Chunli , Li Chunpeng , Liu Shihua , Han Min , Zhang Yanhua , Peng Feifei , Zhao Jing , Qiao Donghai , Li Wenjing , Cai Shengnan , Song Qiuying , Xiao Chenghua , Chen Ming , Lei Junjie , Cai Aimin , Xu Wenfang , Cao Jie , Liu Xinxin , Tan Dong , Feng Tao , Lina Feng , Yan Hongjing , Liu Changxia , Wang Yao , Yang Qinghua , Ji Lin , Xu Jing , Chen Liping , Chen Shuai , Song Yanfeng , Mei Li , Ouyang Sheng , Li Jie , Zhao Defu , Dong Zhaozuo , Jin Wei , Tang Guoxiang , Geng Na , Cai Hongxing , Li Zaewang , Chen Yu , Huang Li , Zhang Yuzhang , Lei Peng , Yan Mingmin , Zhang Xiaojing , Wang Yiqi , Dou Hailing , Wang Kun , Nie Guangjun 
Published: August 2023

Importance

Ginkgo diterpene lactone meglumine (GDLM) has attracted much attention because of its potential neuroprotective properties in ischemic stroke. The efficacy of GDLM in patients with acute ischemic stroke (AIS) needs to be verified by well-designed randomized clinical trials.

Objective

To assess the efficacy and safety of GDLM in patients with AIS.

Design, Setting, and Participants

This multicenter, randomized, double-blind, placebo-controlled, parallel-group trial involved 3448 patients who had AIS, were aged 18 to 80 years, had a clinically diagnosed AIS symptom within 48 hours of onset, had a modified Rankin Scale (mRS) score of 0 or 1 prior to onset, and had a National Institutes of Health Stroke Scale score ranging from 4 to 24. The trial took place at 100 centers in China from February 1, 2016, to May 1, 2018. The mRS is a global stroke disability scale with scores ranging from 0 (no symptoms or completely recovered) to 6 (death). The National Institutes of Health Stroke Scale is a tool used by clinicians to quantify impairment caused by stroke (range, 0-42, with higher scores indicating greater severity). Data were analyzed from January 2019 to December 2022.

Interventions

Patients were randomized to receive GDLM or placebo once daily via intravenous infusion in a 1:1 ratio. The treatment was dispensed within 48 hours after symptoms and continued for 14 days. Interventions of thrombolysis and thrombectomy were not permitted during the treatment.

Main Outcomes and Measures

The primary outcome was the proportion of patients with an mRS of 0 or 1 on day 90 after randomization. Safety outcomes included adverse events and serious adverse events.

Results

A total of 3448 patients were randomized, with 1725 patients assigned to the GDLM group and 1723 patients assigned to the placebo group. The median (IQR) age of the patients was 63 (55-71) years, and 1232 (35.7%) were women. The primary outcome on day 90 occurred in 877 patients (50.8%) in the GDLM group, and 759 patients (44.1%) in the placebo group (risk difference, 6.79%; 95% CI, 3.46%-10.10%; odds ratio, 1.31; 95% CI, 1.15-1.50; relative risk, 1.15; 95% CI, 1.08-1.24; P &amp;lt; .001). Adverse events occurred relatively equally between the 2 groups (303 [17.6%] vs 298 [17.3%]; risk difference, 0.27%; 95% CI, −2.26% to 2.80%; odds ratio, 1.02; 95% CI, 0.85-1.21; relative risk, 1.02; 95% CI, 0.88-1.17; P = .83).

Conclusions and Relevance

Among patients with AIS in this randomized clinical trial, GDLM improved the proportion of patients achieving favorable clinical outcomes at 90 days compared with placebo.

Trial Registration

ClinicalTrials.gov Identifier: NCT02526225