Edaravone dexborneol bests edaravone alone in acute stroke

Administering edaravone dexborneol 48 hours following acute ischaemic stroke (AIS) leads to a more favourable 90-day functional outcome, especially in female patients, as compared with edaravone, according to the results of a phase III study.

The multicentre study enrolled AIS patients aged 35–80 years from 48 hospitals in China. All of them had National Institutes of Health Stroke Scale (NIHSS) Score of 4–24 and were treated within 48 hours of AIS onset.

A total of 1,165 patients were randomized in 1:1 ratio to receive either 14-day infusion of edaravone dexborneol (n=585) or edaravone injection (n=580).

Significantly more patients who received the infusion achieved the primary endpoint of good functional outcome at day 90 after randomization compared to those given the injection (modified Rankin Scale score ≤1, 67.18 percent vs 58.97 percent; odds ratio [OR], 1.42, 95 percent confidence interval [CI], 1.12–1.81; p=0.004).

In the prespecified subgroup analyses, edaravone dexborneol conferred a greater benefit on female patients (OR, 2.26, 95 percent CI, 1.49–3.43) than on their male counterparts (OR, 1.14, 95 percent CI, 0.85–1.52).

Edaravone dexborneol consists of two active ingredients, edaravone and (+)-borneol. The drug has been developed as a novel neuroprotective agent. Animal studies provided evidence of a synergistic effects of antioxidant and anti-inflammatory.