Background/Aims: The emergence of pharmacological neuroprotection in acute stroke management aims to mitigate ischemic cascade effects, improving clinical outcomes. While Edaravone shows promise, its utilization in the Philippines is uncharted. Ensuring patient safety necessitates rigorous surveillance. We aimed to evaluate the safety of intravenous Edaravone for the treatment of Acute Ischemic Stroke among Filipino patients.
Methods: This is a prospective study, categorized as Phase IV, spans from December 2022 to November 2023. The primary objective is to document side effects and serious adverse events during the 14-day Edaravone infusion period. Descriptive statistics were employed for the analysis of the adverse events.
Results: Total of 64 patients were enrolled and 58 completed the treatment, while 4 did not finish, and 2 dropped out. The majority were male (n=35), median age 53.5 years, and 81.03% exhibited moderate stroke severity. Two patients reported headaches (3.5%), and one reported dizziness (1.8%). No serious adverse events or other untoward effects were documented. Dropouts, attributed to a low ejection fraction, showed normal laboratory results and no side effects during Edaravone infusion. Thrombolytic therapy, along with Edaravone, was administered to 37.93% of the patients.
Conclusion: Our study contributes insights into Edaravone's safety, revealing a favorable profile with mild side effects, aligning with existing literature. Notably, no serious adverse events occurred, emphasizing Edaravone's tolerability. Reported side effects did not lead to treatment discontinuation. Overall, the findings support the growing evidence of Edaravone's safety in acute ischemic stroke treatment.