Efficacy and Safety of Edaravone Dexborneol for Treating Acute Ischemic Stroke: A Systematic Review & Meta-analysis

Khaled Moghib¹Mahmoud Tarek Hefnawy²Shehab M. Moawad¹IZERE Salomon^3*Ahmed Hamdi¹Olivier UWISHEMA⁴Mostafa Meshref⁵

• ¹Faculty of Medicine, Kasralainy, Cairo University, Cairo, Egypt
• ²Faculty of Medicine, Zagazig University, Zagazig, Egypt
• ³College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda
• ⁴Oli Health Magazine Organization Kigali, Kigali, Rwanda
• ⁵Department of Neurology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt

Background: Edaravone dexborneol (ED), a novel agent utilized in the treatment of AIS. Studies indicate that this combination exhibits enhanced therapeutic effects when compared to edaravone alone. This assess the efficacy and safety of edaravone dexborneol in the management of AIS. Method: The Study was conducted following the PRISMA guidelines. Literature search was performed, using different databases. We screened articles for eligibility, relevant data were extracted, and the risk of bias was assessed. The primary outcome was efficacy of ED in AIS management. Secondary outcomes encompassed improvements in ADL, reductions in post-stroke depression, etc. Extracted data were analyzed using R. All procedures were pre-specified, and the protocol has been registered with PROSPERO (CRD42024626320). Results: 6 RCTs and 1 cohort study involving 2,942 patients with ischemic stroke (65.6% male), were included. Treatment regimens consisted of intravenous or sublingual ED administered for 10–14 days. Analysis of functional outcomes at 90 days, based on five studies, demonstrated a significant benefit, with a 39.5% higher likelihood of achieving favorable mRS scores (OR = 1.40, 95% CI: 1.18–1.65, p = 0.0001), I² = 0%. Pooled analysis of NIHSS outcomes across seven studies was not significant (SMD = –0.113, 95% CI: –0.333 to 0.107, p = 0.314), with substantial heterogeneity (I² = 72.7%). Under the common-effect model, a small but statistically significant benefit was observed (SMD = –0.083, 95% CI: –0.159 to – 0.008, p = 0.030). Sensitivity analyses indicated that Fu 2024, Hu 2023, Xu 2019, Xu 2024 attenuated the pooled effect, while exclusion of Li 2024 and Hu 2023 reduced heterogeneity to 40.7% but resulted in borderline significance. Secondary endpoints consistently demonstrated favorable effects, including improved ADL, enhanced cognitive function. Safety analyses revealed that adverse events were generally mild and comparable to controls, with some evidence suggesting a reduction in serious complication. Conclusion: Edaravone Dexborneol exhibits considerable potential as a neuroprotective agent in the context of AIS, providing both functional and cognitive advantages, alongside a favorable safety profile. The promising efficacy of this compound underscores the necessity for further comprehensive global studies aimed at optimizing its application and enhancing its relevance across diverse populations.