Edaravone's Safety Profile in Acute Ischemic Stroke

Area of Science:

• Neurology
• Pharmacology
• Clinical Trials

Background:

• Evaluating the safety of intravenous edaravone for acute ischemic stroke treatment in a Filipino population.
• Phase IV clinical trial conducted from December 2022 to November 2023.
• Primary objective: document side effects and serious adverse events during a 14-day edaravone infusion period.

Purpose of the Study:

• Assess the safety and tolerability of intravenous edaravone in Filipino patients diagnosed with acute ischemic stroke.
• Identify and document any adverse events, including serious adverse events, associated with edaravone treatment over 14 days.

Main Methods:

• Institutional Review Board approval and informed consent obtained.
• Inclusion criteria: patients aged 18-70 with acute ischemic stroke within 24 hours.
• Exclusion criteria: extremes of age, pregnancy, severe hepatic impairment, other clinical trial participation.
• Edaravone administered for 14 days with continuous monitoring and active adverse event recording.

Main Results:

• 64 patients enrolled; 58 completed treatment. Majority male (n=35), median age 53.5 years, 81.03% moderate stroke severity.
• Two patients reported headaches, one reported dizziness; no serious adverse events documented.
• Dropouts (n=2) due to low ejection fraction showed normal labs and no side effects; 37.93% received thrombolytic therapy.

Conclusions:

• Intravenous edaravone demonstrated a favorable safety profile in Filipino patients with acute ischemic stroke.
• Mild side effects (headache, dizziness) were observed but did not necessitate treatment discontinuation.
• Findings align with existing literature, supporting edaravone's tolerability and potential in stroke management with vigilant monitoring.