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Does Functional Outcome in Acute Ischaemic Stroke Patients Correlate with the Amount of Free-Radical Scavenger Treatment?

A Retrospective Study of Edaravone Therapy

Clinical Drug Investigation Aims and scope Submit manuscript

Abstract

Background: Edaravone is a free-radical scavenger that has been widely used for acute ischaemic stroke in Japan. However, the optimal total dosage of edaravone has not been established.

Objective: To clarify the relationship between the gain in functional recovery (rehabilitation gain) and the total amount of edaravone used for acute-phase therapy for cerebral infarction at a convalescent rehabilitation hospital. We also sought to determine if there were differences in outcome between stroke subtypes.

Methods: Medical records were retrospectively surveyed to identify patients who had received edaravone treatment for acute-phase cerebral infarction at Kawakita General Hospital, Tokyo, Japan, followed by recovery rehabilitation at Kawakita Rehabilitation Hospital, Tokyo, Japan, for ≥30 days. Edaravone was initiated within 24 hours of stroke onset, and was administered as a 30 mg (1 ampoule) continuous intravenous infusion twice daily for up to 14 days. Patients were stratified into tertiles based on the total amount of edaravone used (measured in ampoules) during the acute phase (i.e. administration duration). Rehabilitation gain was defined as the change (increase) from convalescent rehabilitation hospital admission to discharge in the Functional Independence Measure-Motor (ΔFIM-M) or Barthel Index (ΔBI) score.

Results: Of the 72 enrolled patients, 21 belonged to the lower (short-term) tertile (0–14 ampoules), 27 to the middle (medium-term) tertile (15–23 ampoules) and 24 to the upper (long-term) tertile (24–33 ampoules) groups. There was no correlation between the total amount of edaravone used and the length of stay at an acute-phase hospital. However, a significant correlation was seen between the total amount of edaravone used and ΔFIM-M (adjusted regression coefficient 0.81; p = 0.003) and ΔBI (0.88; p = 0.005) score in patients with cardioembolic stroke; no significant correlation was seen in other stroke subtypes. Cardioembolic stroke patients also showed improvements in both FIM-M and BI score as the total amount of edaravone used increased. The difference between the short- and long-term group was 10.1 (95% CI 2.3, 17.8) for ΔFIM-M score, and 12.0 (95% CI 2.8, 21.2) for ΔBI score. Patients with atherothrombotic stroke showed a similar tendency with respect to ΔBI score.

Conclusion: Edaravone dose-dependently increases rehabilitation gain according to ΔFIM-M and ΔBI scores in patients with cardioembolic stroke, and a similar trend was also observed with respect to ΔBI score in patients with atherothrombotic stroke. This suggests that the total amount of edaravone used is associated with its efficacy for rehabilitation gain.

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Acknowledgements

No sources of funding were used to assist in the conduct of this study. The authors have no conflicts of interest that are directly relevant to the content of this study. Medical writing assistance was provided by Maxwell Chang of inScience Communications. This assistance was funded by Mitsubishi Tanabe Pharma Corporation.

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Correspondence to Yoshiko Unno.

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Unno, Y., Katayama, M. & Shimizu, H. Does Functional Outcome in Acute Ischaemic Stroke Patients Correlate with the Amount of Free-Radical Scavenger Treatment?. Clin. Drug Investig. 30, 143–155 (2010). https://doi.org/10.2165/11535500-000000000-00000

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