TY - JOUR
T1 - Safety and efficacy of edaravone compared to historical controls in patients with amyotrophic lateral sclerosis from North-Eastern Italy
AU - Edaravone Study Group
AU - Fortuna, Andrea
AU - Gizzi, Matteo
AU - Bello, Luca
AU - Martinelli, Ilaria
AU - Bertolin, Cinzia
AU - Pegoraro, Elena
AU - Corbetta, Maurizio
AU - Sorarù, Gianni
N1 - Funding Information:
Supported by Association Française contre les Myopathies ( 18,722 to G.S.), Telethon-Italy ( GTB12001D to A.C.), and EuroBiobank .
Publisher Copyright:
© 2019 Elsevier B.V.
PY - 2019/9/15
Y1 - 2019/9/15
N2 - 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.
AB - 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.
KW - ALS
KW - Edaravone
KW - Therapy
UR - https://www.scopus.com/pages/publications/85068956260
U2 - 10.1016/j.jns.2019.06.006
DO - 10.1016/j.jns.2019.06.006
M3 - Article
C2 - 31325668
AN - SCOPUS:85068956260
SN - 0022-510X
VL - 404
SP - 47
EP - 51
JO - Journal of the Neurological Sciences
JF - Journal of the Neurological Sciences
ER -