Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke, The TASTE-SL Randomized Clinical Trial
RCT (n=914) found among patients with acute ischaemic stroke within 48 hours, edaravone dexborneol produced a significant improvement in good functional outcomes on day 90 versus placebo (risk difference 9.70%; 95%CI 3.37%-16.03%; P=0.003). Adverse events similar between groups.
Source:
JAMA Neurology
SPS commentary:
Edaravone is a low-molecular-weight drug with free radical scavenging and antioxidant activities based on studies that have shown it protects neurons, glia (microglia, astrocytes, and oligodendrocytes), and vascular endothelial cells against oxidative stress and attenuates the inflammatory response of activated microglial cells. Sublingual edaravone dexborneol, which can rapidly diffuse and be absorbed through the oral mucosa after sublingual exposure, is a multitarget brain cytoprotectant composed of antioxidant and anti-inflammatory ingredients edaravone and dexborneol.
A related editorial highlights the litany of failed neuroprotection trials in acute ischaemic stroke, with recent trials challenging how viable versus dead tissue is defined on brain imaging. It praises the authors for choosing a high-quality study design with broad inclusion criteria and randomisation. However, it highlights the inconsistencies in the study outcomes, particularly higher than expected treatment effect. It notes the study was powered at 80% rather than a more conventional 90% for a phase 3 trial.