Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke,JAMA Neurology

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Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke
JAMA Neurology ( IF 29.0 ) Pub Date : 2024-02-19 , DOI: 10.1001/jamaneurol.2023.5716
Yu Fu ₁ , Anxin Wang ₂ , Renhong Tang ₃ , Shuya Li _{4,

5} , Xue Tian _{6,

7} , Xue Xia _{4,

5} , Jinsheng Ren _{3,

8} , Shibao Yang ₉ , Rong Chen ₉ , Shunwei Zhu _{3,

8} , Xiaofei Feng _{3,

8} , Jinliang Yao ₉ , Yan Wei ₁₀ , Xueshuang Dong ₁₁ , Yun Ling ₁₂ , Fei Yi ₁₃ , Qian Deng ₁₄ , Cunju Guo ₁₅ , Yi Sui ₁₆ , Shugen Han ₁₇ , Guoqiang Wen ₁₈ , Chuanling Li ₁₉ , Aiqin Dong ₂₀ , Xin Sun ₂₁ , Zhimin Wang ₂₂ , Xueying Shi ₂₃ , Bo Liu ₂₄ , Dongsheng Fan ₁

Affiliation

Department of Neurology, Peking University Third Hospital, Beijing, China
Beijing Neurosurgical Institute, Capital Medical University, Beijing, China
State Key Laboratory of Neurology and Oncology Drug Development, Nanjing, China
Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
Department of Clinical Epidemiology and Clinical Trial, Capital Medical University, Beijing, China
Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, China
Simcere Pharmaceutical Group Limited, Nanjing, China
Neurodawn Pharmaceutical Co Ltd, Nanjing, China
Harrision International Peace Hospital, Hengshui, China
Daqing Oilfied General Hospital, Daqing, China
Nanshi Hospital of Nanyang, Nanyang, China
Pingxiang People’s Hospital, Pingxiang, China
The First Affiliated Hospital of Nanyang Medical College, Nanyang, China
Liaocheng People’s Hospital, Liaocheng, China
The First People’s Hospital of Shenyang, Shenyang, China
Mei He Kou Central Hospital, Jilin, China
Hainan General Hospital, Hainan, China
Xuzhou Central Hospital, Jiangsu, China
Cangzhou Central Hospital, Hebei, China
The First Hospital of Jilin University, Jilin, China
Taizhou First People’s Hospital, Zhejiang, China
Anqing Municipal Hospital, Anhui, China
The First Affiliated Hospital Baotou Medical College, Baotou, China

ImportanceSublingual edaravone dexborneol, which can rapidly diffuse and be absorbed through the oral mucosa after sublingual exposure, is a multitarget brain cytoprotection composed of antioxidant and anti-inflammatory ingredients edaravone and dexborneol.ObjectiveTo investigate the efficacy and safety of sublingual edaravone dexborneol on 90-day functional outcome in patients with acute ischemic stroke (AIS).Design, Setting, and ParticipantsThis was a double-blind, placebo-controlled, multicenter, parallel-group, phase 3 randomized clinical trial conducted from June 28, 2021, to August 10, 2022, with 90-day follow-up. Participants were recruited from 33 centers in China. Patients randomly assigned to treatment groups were aged 18 to 80 years and had a National Institutes of Health Stroke Scale score between 6 and 20, a total motor deficit score of the upper and lower limbs of 2 or greater, a clinically diagnosed AIS symptom within 48 hours, and a modified Rankin Scale (mRS) score of 1 or less before stroke. Patients who did not meet the eligibility criteria or declined to participate were excluded.InterventionPatients were assigned, in a 1:1 ratio, to receive sublingual edaravone dexborneol (edaravone, 30 mg; dexborneol, 6 mg) or placebo (edaravone, 0 mg; dexborneol, 60 μg) twice daily for 14 days and were followed up until 90 days.Main Outcomes and MeasuresThe primary efficacy outcome was the proportion of patients with mRS score of 1 or less on day 90 after randomization.ResultsOf 956 patients, 42 were excluded. A total of 914 patients (median [IQR] age, 64.0 [56.0-70.0] years; 608 male [66.5%]) were randomly allocated to the edaravone dexborneol group (450 [49.2%]) or placebo group (464 [50.8%]). The edaravone dexborneol group showed a significantly higher proportion of patients experiencing good functional outcomes on day 90 after randomization compared with the placebo group (290 [64.4%] vs 254 [54.7%]; risk difference, 9.70%; 95% CI, 3.37%-16.03%; odds ratio, 1.50; 95% CI, 1.15-1.95, P = .003). The rate of adverse events was similar between the 2 groups (89.8% [405 of 450] vs 90.1% [418 of 464]).Conclusion and RelevanceAmong patients with AIS within 48 hours, sublingual edaravone dexborneol could improve the proportion of those achieving a favorable functional outcome at 90 days compared with placebo.Trial RegistrationClinicalTrials.gov Identifier: NCT04950920

更新日期：2024-02-19

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