6533b85efe1ef96bd12c06c3
RESEARCH PRODUCT
Effect of High‐Caloric Nutrition on Survival in Amyotrophic Lateral Sclerosis
Johannes PrudloUlrike WeilandSusanne PetriJens DreyhauptThomas F. MeyerBertold SchrankAlbert C. LudolphAlbert C. LudolphDaniel ZellerJulian GrosskreutzLuc DupuisAndrea Sylvia WinklerFranceso RoselliAndreas HermannAndreas HermannJochen H. WeishauptJan KassubekJohannes DorstAlexander EmmerMatthias BoentertTorsten GrehlJoachim SchusterStanislav Gorbulevsubject
Male0301 basic medicinemortality [Amyotrophic Lateral Sclerosis]MESH: Combined Modality Therapy[SDV]Life Sciences [q-bio]law.invention0302 clinical medicineMESH: RiluzoleRandomized controlled triallawdiet therapy [Amyotrophic Lateral Sclerosis]Clinical endpointMedicineMESH: Double-Blind Methodtherapeutic use [Riluzole]MESH: Amyotrophic Lateral Sclerosismethods [Combined Modality Therapy]education.field_of_studyRiluzoleMESH: Middle AgedHazard ratioMESH: Neuroprotective AgentsMiddle Agedtherapeutic use [Neuroprotective Agents]Combined Modality Therapy3. Good healthRiluzole[SDV] Life Sciences [q-bio]Neuroprotective AgentsNeurologyMESH: Survival AnalysisFemalemedicine.drugmortality [Diet High-Fat]medicine.medical_specialtyPopulationDiet High-FatPlacebo03 medical and health sciencesDouble-Blind MethodInternal medicineHumansddc:610educationSurvival analysisMESH: Humansdrug therapy [Amyotrophic Lateral Sclerosis]business.industryAmyotrophic Lateral SclerosisSurvival AnalysisConfidence intervalMESH: MaleMESH: Diet High-Fat030104 developmental biologyNeurology (clinical)businessMESH: Female030217 neurology & neurosurgerydescription
International audience; Objective: 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.Methods: 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.Results: 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, p = 0.44.Interpretation: 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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2019-12-10 |