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Research Article| Volume 404, P47-51, September 15, 2019

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Safety and efficacy of edaravone compared to historical controls in patients with amyotrophic lateral sclerosis from North-Eastern Italy

  • Author Footnotes
    1 These authors contributed equally to the work.
    Andrea Fortuna
    Footnotes
    1 These authors contributed equally to the work.
    Affiliations
    Neuromuscular Center, Department of Neurosciences, University of Padova, Italy
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  • Author Footnotes
    1 These authors contributed equally to the work.
    Matteo Gizzi
    Footnotes
    1 These authors contributed equally to the work.
    Affiliations
    Neuromuscular Center, Department of Neurosciences, University of Padova, Italy
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  • Luca Bello
    Affiliations
    Neuromuscular Center, Department of Neurosciences, University of Padova, Italy
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  • Ilaria Martinelli
    Affiliations
    Neuromuscular Center, Department of Neurosciences, University of Padova, Italy
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  • Cinzia Bertolin
    Affiliations
    Neuromuscular Center, Department of Neurosciences, University of Padova, Italy
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  • Elena Pegoraro
    Affiliations
    Neuromuscular Center, Department of Neurosciences, University of Padova, Italy
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  • Maurizio Corbetta
    Affiliations
    Neuromuscular Center, Department of Neurosciences, University of Padova, Italy

    Department of Neurosciences, University of Padova, Italy
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  • Gianni Sorarù
    Correspondence
    Corresponding author at: Neuromuscular Center, Department of Neurosciences, University of Padova, 35128 Padova, Italy.
    Affiliations
    Neuromuscular Center, Department of Neurosciences, University of Padova, Italy
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  • Edaravone Study Group
    Author Footnotes
    2 G.S., E.P., and A.M. designed the research; A.F., M.G. and I.M. performed evaluations; L.B. conducted statistical analysis; G.S., C.B. and L.B. performed data analysis.; Medical Doctors belonging to EDARAVONE STUDY GROUP performed pre-starting evaluations and strict patients' follow up. All authors wrote and reviewed the article.
  • Author Footnotes
    1 These authors contributed equally to the work.
    2 G.S., E.P., and A.M. designed the research; A.F., M.G. and I.M. performed evaluations; L.B. conducted statistical analysis; G.S., C.B. and L.B. performed data analysis.; Medical Doctors belonging to EDARAVONE STUDY GROUP performed pre-starting evaluations and strict patients' follow up. All authors wrote and reviewed the article.
Published:June 05, 2019DOI:https://doi.org/10.1016/j.jns.2019.06.006
Safety and efficacy of edaravone compared to historical controls in patients with amyotrophic lateral sclerosis from North-Eastern Italy
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      Highlights

      • •
        We conducted a retrospective study on edaravone in a Caucasian ALS population.
      • •
        No benefit on ALS progression was observed at 3 and 6 months.
      • •
        Creatinine values significantly decreased in treated patients at 3 and 6 months.
      • •
        Quality of life significantly worsened in treated patients at 3 and 6 months.
      • •
        Edaravone was overall well tolerated.

      Abstract

      Objective

      To test efficacy and tolerability of edaravone in patients with amyotrophic lateral sclerosis (ALS) originating from North-Eastern Italy.

      Methods

      We compared 3-month and 6-month changes of ALSFRS-R score, FVC value, and MRC score of 31 consecutive patients with ALS who were treated with edaravone to those of 50 historical ALS patients who were not treated with edaravone.

      Results

      No significant difference for any functional measures was found between the two groups at each time point as compared to baseline. In treated patients, we also observed creatinine values to significantly decrease at 3 and 6 months (p = 0.0078 and 0.030, respectively) and ALSAQ5 score to significantly increase (i.e. worse quality of life) at 3 and 6 months (p = 0.0005 and 0.0078, respectively). Yet, we observed an overall safety of the medication over the 6-month period of observation.

      Conclusions

      Our retrospective study suggests no benefit of edaravone on ALS in populations of Caucasian ancestry.

      Keywords

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      Article info

      Publication history

      Published online: June 05, 2019
      Accepted: June 4, 2019
      Received in revised form: May 14, 2019
      Received: March 20, 2019

      Identification

      DOI: https://doi.org/10.1016/j.jns.2019.06.006

      Copyright

      © 2019 Elsevier B.V. All rights reserved.

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