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Lithium lacks effect on survival in amyotrophic lateral sclerosis: a phase IIb randomised sequential trial.

AbstractOBJECTIVES:
To determine the safety and efficacy of lithium for the treatment of amyotrophic lateral sclerosis (ALS) in a randomised, placebo controlled, double blind, sequential trial.
METHODS:
Between November 2008 and June 2011, 133 patients were randomised to receive lithium carbonate (target blood level 0.4-0.8 mEq/l) or placebo as add-on treatment with riluzole. The primary endpoint was survival, defined as death, tracheostomal ventilation or non-invasive ventilation for more than 16 h/day. Secondary outcome measures consisted of the revised ALS Functional Rating Scale and forced vital capacity. Analysis was by intention to treat and according to a sequential trial design.
RESULTS:
61 patients reached a primary endpoint, 33 of 66 in the lithium group and 28 of 67 patients in the placebo group. Lithium did not significantly affect survival (cumulative survival probability of 0.73 in the lithium group (95% CI 0.63 to 0.86) vs 0.75 in the placebo group (95% CI 0.65 to 0.87) at 12 months and 0.62 in the lithium group (95% CI 0.50 to 0.76) vs 0.67 in the placebo group (95% CI 0.56 to 0.81) at 16 months). Secondary outcome measures did not differ between treatment groups. No major safety concerns were encountered.
CONCLUSIONS:
This trial, designed to detect a modest effect of lithium, did not demonstrate any beneficial effect on either survival or functional decline in patients with ALS.
TRIAL REGISTRATION NUMBER:
NTR1448. Name of trial registry: Lithium trial in ALS.
AuthorsEsther Verstraete, Jan H Veldink, Mark H B Huisman, Tim Draak, Esther V Uijtendaal, Anneke J van der Kooi, H Jurgen Schelhaas, Marianne de Visser, Ingeborg van der Tweel, Leonard H van den Berg
JournalJournal of neurology, neurosurgery, and psychiatry (J Neurol Neurosurg Psychiatry) Vol. 83 Issue 5 Pg. 557-64 (May 2012) ISSN: 1468-330X [Electronic] England
PMID22378918 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Lithium Carbonate
  • Riluzole
Topics
  • Activities of Daily Living
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amyotrophic Lateral Sclerosis (blood, drug therapy, mortality)
  • Double-Blind Method
  • Drug Therapy, Combination (adverse effects)
  • Female
  • Humans
  • Lithium Carbonate (adverse effects, blood, therapeutic use)
  • Male
  • Middle Aged
  • Pulmonary Ventilation (drug effects)
  • Riluzole (therapeutic use)
  • Survival Rate
  • Vital Capacity (drug effects)

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