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Real‐world safety of the novel, free radical scavenger edaravone for amyotrophic lateral sclerosis patients: Data from the post‐marketing surveillance SUNRISE Japan
Author(s) -
Ishizaki Kaoru,
Yoshimura Kenta,
Yoshida Kengo,
Matsuda Masao,
Kawaguchi Yutaka,
Yuki Satoshi,
Sobue Gen
Publication year - 2021
Publication title -
neurology and clinical neuroscience
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.125
0ISSN - 2049-4173
DOI - 10.1111/ncn3.12490
Subject(s) - edaravone , medicine , amyotrophic lateral sclerosis , incidence (geometry) , free radical scavenger , adverse effect , riluzole , concomitant , surgery , disease , physics , oxidative stress , optics
Background Treatment options for amyotrophic lateral sclerosis (ALS) are limited. SUNRISE Japan is an ongoing post‐marketing surveillance evaluating the long‐term efficacy and safety of edaravone, a novel neuroprotectant agent, and free radical scavenger, in patients with ALS. Aim This study aims to describe the real‐word safety results of ALS patients enrolled in SUNRISE Japan. Methods Patients diagnosed with ALS and prescribed edaravone for the first time during the surveillance period were included. Patients were prescribed edaravone according to the prescribing information. The incidence of adverse drug reactions (ADRs) reported up to 1 year of follow‐up was evaluated. Results Of 805 patients enrolled up to April 2020, 800 were included in the safety analysis set. Patients had a mean age of 66.3 years, 55.1% were male, and they had a mean disease duration of 1.8 years. In total, 97 patients (12.1%) reported at least one ADR, with a total of 148 ADR events reported. Thirty patients (3.8%) reported at least one serious ADR with a total of 42 serious ADR events reported. Hepatic function abnormal was the most frequently reported ADR, with an incidence of 4.4% (35/800). A higher incidence of ADRs was observed in patients with percent forced vital capacity ≥80%, and those with previous/concomitant treatment with riluzole. Conclusion In this surveillance study, hepatic ADRs were the most frequently reported events. These ADRs have also been reported previously in patients receiving standard therapy. No new safety concerns were raised with real‐world use of edaravone.