TASTE-SL
Trial question
What is the role of sublingual edaravone dexborneol in patients with AIS?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 914
914 patients (306 female, 608 male).
Inclusion criteria: adult patients with AIS within 48 hours.
Key exclusion criteria: ICH; severe disturbance of consciousness; TIA; severe mental disorders and dementia; severe active liver diseases.
Interventions
N=450 edaravone dexborneol (sublingual edaravone 30 mg and dexborneol 6 mg BID for 14 days).
N=464 placebo (sublingual matching placebo BID for 14 days).
Primary outcome
Rate of modified Rankin Scale score ≤ 1 on day 90
64.4%
54.7%
64.4 %
48.3 %
32.2 %
16.1 %
0.0 %
Edaravone
dexborneol
Placebo
Significant
increase ▲
NNT = 10
Significant increase in the rate of mRS score ≤ 1 on day 90 (64.4% vs. 54.7%; OR 1.5, 95% CI 1.15 to 1.95).
Secondary outcomes
Significant increase in median mRS score on day 90 (1 point vs. 1 point; OR 1.33, 95% CI 1.05 to 1.68).
No significant difference in the rate of mRS score ≤ 2 on day 90 (76% vs. 72.6%; OR 1.19, 95% CI 0.89 to 1.61).
No significant difference in the rate of NIHSS score < = 1 on day 90 (57.2% vs. 51.6%; OR 1.26, 95% CI 0.95 to 1.65).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In adult patients with AIS within 48 hours, edaravone dexborneol was superior to placebo with respect to the rate of mRS score ≤ 1 on day 90.
Reference
Yu Fu, Anxin Wang, Renhong Tang et al. Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke: The TASTE-SL Randomized Clinical Trial. JAMA Neurol. 2024 Feb 19;81(4):319-326. Online ahead of print.
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