The Italian multicenter experience with edaravone in amyotrophic lateral sclerosis
- PDF / 811,877 Bytes
- 10 Pages / 595.276 x 790.866 pts Page_size
- 25 Downloads / 167 Views
ORIGINAL COMMUNICATION
The Italian multicenter experience with edaravone in amyotrophic lateral sclerosis Christian Lunetta1 · Cristina Moglia2,3 · Andrea Lizio1 · Claudia Caponnetto4 · Raffaele Dubbioso5 · Fabio Giannini18 · Sabrina Matà6 · Letizia Mazzini7 · Mario Sabatelli8,9 · Gabriele Siciliano10 · Isabella Laura Simone11 · Gianni Sorarù12 · Antonella Toriello13 · Francesca Trojsi14 · Marcella Vedovello15 · Fabrizio D’Ovidio2 · Massimo Filippi16,17 · Andrea Calvo2,3 · and EDARAVALS Study Group Received: 28 April 2020 / Revised: 8 June 2020 / Accepted: 10 June 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Objectives The aim of the study is to analyze the ALS disease progression and respiratory function of Italian patients treated with edaravone (EVN), as well as the adherence to, and the effects of, the therapy. Methods We performed an observational study of patients treated with EVN from May 2017 to May 2019, in 39 Italian ALS Centers. Taking into account ALS patients with at least 12 months of EVN treatment, we compared the decline of ALSFRS-R and FVC with a group of matched historical controls from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database, using both descriptive and survival analysis approaches. Results A total of 331 ALS Italian patients treated with EVN and 290 matched historical controls were recruited in this study. No significant differences on disease progression or respiratory function were found comparing the two cohorts in both descriptive and survival analyses. The EVN treatment was overall well tolerated. Conclusions The study showed that EVN treatment was well tolerated. No significant differences were reported in ALS patients treated and not treated with EVN, in terms of both disease progression and respiratory function. These findings prove that further studies are required to better clarify whether EVN could be considered an effective treatment for ALS disease. Keywords Amyotrophic lateral sclerosis · Edaravone · Multicenter study · Observational study
Introduction An urgent unmet need persists for effective therapies significantly improving disease progression, survival, and/or quality of life in amyotrophic lateral sclerosis (ALS). Edaravone (EVN) phase II study showed that in the group treated with 60 mg/day, there was a significant lower decline
Christian Lunetta, Cristina Moglia, and Andrea Lizio have contributed equally to the manuscript. Fabrizio D’Ovidio, Massimo Filippi, and Andrea Calvo have contributed equally to the manuscript. The members of the EDARAV-ALS Study Group are listed in acknowledgements. * Andrea Calvo [email protected]
of ALSFRS score in the 6 months of treatment. A phase III clinical trial suggested no significant effects in ALS, although there was a trend towards slower disease progression in patients taking the drug [1]. A post hoc analysis was performed in a subgroup of patients with the following findings: % forced vital capacity (FVC) of ≥ 80%, ≥ 2 points for all item scores in the ALS Fu
Data Loading...
