Long‐term edaravone efficacy in amyotrophic lateral sclerosis: Post‐hoc analyses of Study 19 (MCI186‐19)
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- Jeremy Shefner
- Barrow Neurological Institute Phoenix Arizona
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- Terry Heiman‐Patterson
- Temple University Philadelphia Pennsylvania
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- Erik P. Pioro
- Cleveland Clinic Cleveland Ohio
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- Martina Wiedau‐Pazos
- David Geffen School of Medicine University of California, Los Angeles Los Angeles California
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- Shawn Liu
- Mitsubishi Tanabe Pharma Development America, Inc. Jersey City New Jersey
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- Jeffrey Zhang
- Princeton Pharmatech Princeton Junction New Jersey
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- Wendy Agnese
- Formerly Mitsubishi Tanabe Pharma America, Inc. Jersey City New Jersey
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- Stephen Apple
- Mitsubishi Tanabe Pharma America, Inc. Jersey City New Jersey
Abstract
<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>In a Phase 3 study, amyotrophic lateral sclerosis (ALS) patients experienced significantly less physical functional decline with 24‐week edaravone vs placebo, followed by open‐label treatment for an additional 24 weeks.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Outcome (the change in ALS Functional Rating Scale–Revised, ALSFRS‐R, from baseline) was projected for placebo patients through 48 weeks and compared with 48‐week edaravone or 24‐week edaravone after switching from placebo.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A total of 123 patients received open‐label treatment (65 edaravone‐edaravone; 58 placebo‐edaravone). The projected ALSFRS‐R decline for placebo from baseline through week 48 was greater than for 48‐week edaravone (<jats:italic>P</jats:italic> < .0001). For patients switching from placebo to edaravone, ALSFRS‐R slope approached that of continued edaravone for 48 weeks. ALSFRS‐R decline did not differ between actual and projected edaravone through week 48.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Compared with placebo, these analyses suggest that edaravone is beneficial in ALS patients even after 6 mo of receiving placebo, and efficacy is maintained for up to 1 year.</jats:p></jats:sec>
Journal
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- Muscle & Nerve
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Muscle & Nerve 61 (2), 218-221, 2019-11-11
Wiley
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Details 詳細情報について
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- CRID
- 1360861710822895616
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- ISSN
- 10974598
- 0148639X
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- Data Source
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- Crossref