Effect of High‐Caloric Nutrition on Survival in Amyotrophic Lateral Sclerosis
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- Albert C. Ludolph
- Department of Neurology University of Ulm Ulm Germany
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- Johannes Dorst
- Department of Neurology University of Ulm Ulm Germany
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- Jens Dreyhaupt
- Institute of Epidemiology and Medical Biometry University of Ulm Ulm Germany
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- Jochen H. Weishaupt
- Department of Neurology University of Ulm Ulm Germany
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- Jan Kassubek
- Department of Neurology University of Ulm Ulm Germany
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- Ulrike Weiland
- Department of Neurology University of Ulm Ulm Germany
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- Thomas Meyer
- Charité–Universitätsmedizin Berlin Humboldt University of Berlin Berlin Germany
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- Susanne Petri
- Department of Neurology Hannover Medical School Hannover Germany
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- Andreas Hermann
- Department of Neurology Dresden University of Technology and German Center for Neurodegenerative Diseases Dresden Germany
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- Alexander Emmer
- Department of Neurology Halle University Hospital Halle/Saale Germany
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- Julian Grosskreutz
- Department of Neurology Jena University Hospital Jena Germany
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- Torsten Grehl
- Department of Neurology Bergmannsheil University Hospital Bochum Germany
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- Daniel Zeller
- Department of Neurology University of Würzburg Würzburg Germany
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- Matthias Boentert
- Department of Neurology Institute of Translational Neurology, Münster University Hospital Münster Germany
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- Bertold Schrank
- Department of Neurology Deutsche Klinik für Diagnostik HELIOS Clinic of Wiesbaden Wiesbaden Germany
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- Johannes Prudlo
- Department of Neurology University of Rostock Rostock Germany
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- Andrea S. Winkler
- Department of Neurology Technical University of Munich Munich Germany
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- Stanislav Gorbulev
- Interdisciplinary Center for Clinical Trials Mainz University Medical Center Mainz Germany
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- Francesco Roselli
- Department of Neurology University of Ulm Ulm Germany
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- Joachim Schuster
- Department of Neurology University of Ulm Ulm Germany
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- Luc Dupuis
- National Institute of Health and Medical Research University of Strasbourg Strasbourg France
説明
<jats:sec><jats:title>Objective</jats:title><jats:p>Weight loss has been identified as a negative prognostic factor in amyotrophic lateral sclerosis, but there is no evidence regarding whether a high‐caloric diet increases survival. Therefore, we sought to evaluate the efficacy of a high‐caloric fatty diet (HCFD) for increasing survival.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>A 1:1 randomized, placebo‐controlled, parallel‐group, double‐blinded trial (LIPCAL‐ALS study) was conducted between February 2015 and September 2018. Patients were followed up at 3, 6, 9, 12, 15, and 18 months after randomization. The study was performed at 12 sites of the clinical and scientific network of German motor neuron disease centers (ALS/MND‐NET). Eligible patients were randomly assigned (1:1) to receive either HCFD (405kcal/day, 100% fat) or placebo in addition to riluzole (100mg/day). The primary endpoint was survival time, defined as time to death or time to study cutoff date.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Two hundred one patients (80 female, 121 male, age = 62.4 ± 10.8 years) were included. The confirmatory analysis of the primary outcome survival showed a survival probability of 0.39 (95% confidence interval [CI] = 0.27–0.51) in the placebo group and 0.37 (95% CI = 0.25–0.49) in the HCFD group, both after 28 months (point in time of the last event). The hazard ratio was 0.97, 1‐sided 97.5% CI = −∞ to 1.44, <jats:italic>p</jats:italic> = 0.44.</jats:p></jats:sec><jats:sec><jats:title>Interpretation</jats:title><jats:p>The results provide no evidence for a life‐prolonging effect of HCFD for the whole amyotrophic lateral sclerosis population. However, post hoc analysis revealed a significant survival benefit for the subgroup of fast‐progressing patients. ANN NEUROL 2020;87:206–216</jats:p></jats:sec>
収録刊行物
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- Annals of Neurology
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Annals of Neurology 87 (2), 206-216, 2020-01-06
Wiley