Sublingual Edaravone Dexborneol Effective for Acute Ischemic Stroke

A double-blind, placebo-controlled, multicenter, parallel-group, phase 3 randomized clinical trial in China revealed that sublingual edaravone dexborneol improved functional outcome at 90 days compared to placebo in patients with acute ischemic stroke (AIS). Within 48 hours of diagnosis, 914 AIS patients (median age, 64.0 [56.0-70.0] years; male 66.5%) were randomly allocated to the edaravone dexborneol (49.2%; edaravone 30 mg; dexborneol 6 mg) or placebo (50.8%; dexborneol 60 μg to simulate the cool taste) group twice daily for 14 days from June 28, 2021, to August 10, 2022, with 90-day follow-up. There was a significantly higher proportion of patients with good functional outcomes at day 90 post randomization in the edaravone dexborneol group compared to the placebo group (64.4% vs 54.7%; net difference, 9.7%; odds ratio, 1.50; P = .003). Adverse events were similar between the 2 groups (89.8% vs 90.1%). The findings have major potential practice implications consider its fast-acting, low cost and convenience, even in unconscious, disabled, or dysphagic patients. Both active ingredients are neuroprotectants with synergistic antioxidant and anti-inflammatory effects. Maximizing access to reperfusion treatment is at the forefront of modern AIS services (time is brain). Source: https://jamanetwork.com