Prospective Open‐Label Safety Study of Edaravone Dexborneol in Filipino Patients With Acute Ischemic Stroke

TL;DR

This study shows that edaravone dexborneol is safe and well-tolerated in Filipino patients with acute ischemic stroke, with mostly mild and temporary side effects.

Contribution

The study provides the first real-world safety data of edaravone dexborneol in Filipino acute ischemic stroke patients.

Findings

Most adverse events were mild, with headache and elevated liver enzymes being the most common.

No life-threatening reactions, deaths, or treatment discontinuations occurred during the study.

Safety findings align with international data, supporting its potential use in the Philippines.

Abstract

Edaravone dexborneol is a neuroprotective agent combining the free‐radical scavenging properties of edaravone and the anti‐inflammatory, blood–brain barrier–modulating effects of dexborneol. While international trials have demonstrated favorable safety and potential clinical benefit, data in Filipino patients remain lacking. This study evaluated the real‐world safety and tolerability of edaravone dexborneol among Filipino patients with acute ischemic stroke.

This was a single‐center, open‐label, single‐arm, prospective study conducted under a compassionate‐use program. Patients aged 18–80 years with clinically confirmed acute ischemic stroke within 48 h of onset received edaravone dexborneol (30 mg edaravone + 7.5 mg dexborneol) twice daily for 14 days. Safety monitoring continued until Day 20. Treatment‐emergent adverse events (TEAEs) and serious adverse events (SAEs) were classified using the International Council for Harmonisation (ICH E2A) criteria, and causality was assessed using the World Health Organization–Uppsala Monitoring Centre (WHO–UMC) categories.

Twenty‐seven of 29 enrolled patients completed the 14‐day regimen. Mean age was 55.7 ± 12.8 years; 66.7% were male. Overall, 15 patients (55.6%) experienced at least one TEAE, most commonly headache (29.6%), which occurred on Day 0 and resolved within 0.7 ± 1.2 days. Elevated liver enzymes were observed in 25.9% for aspartate transaminase (AST) as well as for alanine aminotransferase (ALT), generally mild and self‐limited. One patient developed both moderate transaminitis and acute kidney injury, attributed to concurrent antituberculosis therapy rather than the study drug. No treatment discontinuations, life‐threatening reactions, or deaths occurred.

Edaravone dexborneol demonstrated a favorable safety profile in Filipino patients with acute ischemic stroke, with adverse events (AE) predominantly mild, transient, and reversible. These real‐world findings align with international data and support their potential incorporation into acute stroke management pathways in the Philippines.

This prospective, single‐arm study evaluated the real‐world safety of edaravone dexborneol in Filipino patients with acute ischemic stroke treated within 48 h of symptom onset. Adverse events were predominantly mild and transient, with headache and reversible liver enzyme elevations being the most common. No treatment discontinuations, life‐threatening reactions, or deaths occurred, supporting a favorable safety and tolerability profile in this population.

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