Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke
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Published:2023-08-14
Issue:8
Volume:6
Page:e2328828
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ISSN:2574-3805
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Container-title:JAMA Network Open
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language:en
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Short-container-title:JAMA Netw Open
Author:
Zhang Qian12, Wang Anxin12, Xu Qin12, Xia Xue12, Tian Xue1234, Zhang Yijun1234, Li Xiaolong5, Yang Xiusheng6, Wang Xingchen7, Peng Jinghua8, Li Yanchun9, Liu Luran10, Jin Shunshan11, Meng Xia12, Zhao Xingquan121213, Wang Yongjun14, He Maolin14, Dong Qiang14, Zhao Gang14, Chen Kangning14, Xie Peng14, Xu Yun14, Yang Yi14, Guo Li14, Li Yansheng14, Wang Yilong14, Zhang Xiaoli14, Xu Anding14, Pan Xudong14, Xiao Cuilan14, Wang David14, Li Hao14, Gao Ying14, Xia Jielai14, Zhao Hongjian14, Wang Huijuan14, He Yue14, Li Weili14, Wei Xiangyang14, Bai Junqing14, Cao Shiwei14, Song Ying14, Ma Zhanhu14, Zhang Na14, Yin Nianzhen14, Zeng Long14, Zhang Likun14, Yang Fang14, Zhang Jing14, Wang Jian14, Tang Huili14, Li Yinghua14, Zhou Hourong14, Feng Haisong14, Song Dongjing14, Wang Jianyu14, Ma Yongcui14, Chen Lihui14, Xiao Kaiwen14, Zhai Qijin14, Li Jing14, Li Xiaojie14, Yang Yinqiao14, Mei Xue14, Zhu Ziyun14, Zhang Yan14, Liu Yuhu14, Nie Hongxia14, Fu Bing14, Huang Gang14, Zeng Guoli14, Liu Bingrong14, Xiaomin Wang14, Xu Lianying14, Zhang Fan14, Wang Lan14, Han Wei14, Meng Shanshan14, Xiao Chang'e14, Yang Zhijie14, Deng Yanqing14, Ying Hu14, Tang Li14, Jia Chunli14, Li Chunpeng14, Liu Shihua14, Han Min14, Zhang Yanhua14, Peng Feifei14, Zhao Jing14, Qiao Donghai14, Li Wenjing14, Cai Shengnan14, Song Qiuying14, Xiao Chenghua14, Chen Ming14, Lei Junjie14, Cai Aimin14, Xu Wenfang14, Cao Jie14, Liu Xinxin14, Tan Dong14, Feng Tao14, Lina Feng14, Yan Hongjing14, Liu Changxia14, Wang Yao14, Yang Qinghua14, Ji Lin14, Xu Jing14, Chen Liping14, Chen Shuai14, Song Yanfeng14, Mei Li14, Ouyang Sheng14, Li Jie14, Zhao Defu14, Dong Zhaozuo14, Jin Wei14, Tang Guoxiang14, Geng Na14, Cai Hongxing14, Li Zaewang14, Chen Yu14, Huang Li14, Zhang Yuzhang14, Lei Peng14, Yan Mingmin14, Zhang Xiaojing14, Wang Yiqi14, Dou Hailing14, Wang Kun14, Nie Guangjun14,
Affiliation:
1. Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China 2. China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China 3. Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, Beijing, China 4. Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, China 5. Department of Neurology, Xiangyang No. 1 People’s Hospital, Hubei, China 6. Department of Neurology, The First People’s Hospital of Yuanping City, Shanxi, China 7. Department of Neurology, The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shandong, China 8. Department of Neurology, Jiujiang No. 1 People’s Hospital, Jiangxi, China 9. Department of Neurology, The First Affiliated Hospital Of Hunan University of Medicine, Hunan, China 10. Department of Neurology, The Fourth Hospital of Harbin Medical University, Heilongjiang, China 11. Department of Neurology, Beidahuang Group General Hospital, Heilongjiang, China 12. Research Unit of Artificial Intelligence in Cerebrovascular Disease, Chinese Academy of Medical Sciences, Beijing, China 13. Beijing Institute of Brain Disorders, Collaborative Innovation Center for Brain Disorders, Capital Medical University, Beijing, China 14. for the GDLM group
Abstract
ImportanceGinkgo 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.ObjectiveTo assess the efficacy and safety of GDLM in patients with AIS.Design, Setting, and ParticipantsThis 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.InterventionsPatients 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 MeasuresThe 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.ResultsA 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 < .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 RelevanceAmong 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 RegistrationClinicalTrials.gov Identifier: NCT02526225
Publisher
American Medical Association (AMA)
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