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Mirian Conceicao Moura*, Luiz Augusto Casulari, Maria Rita Carvalho Garbi Novaes


Objective: to describe the adverse events and tolerability of lithium carbonate plus riluzole used in a trial to reduce the progression of amyotrophic lateral sclerosis. Methods: An 18-month, randomized controlled clinical trial, phase 2 open parallel, with two arms was used. The experimental group (n=30) received riluzole 100 mg/day plus lithium carbonate (blood level: 0.4 to 0.8 mEq/l), and the control group (n=30) received riluzole 100 mg/day. The participants were evaluated each 3-4 months. The primary outcome was time of tracheostomy or death. The secondary outcomes were ALSFRS scale, muscle strength, forced vital capacity, hemoglobin saturation and neurophysiological biomarkers. Results: Twenty-two patients who used lithium carbonate and riluzole discontinued the medication. Of these, eight (26.7%) considered the drug ineffective and 14 (46.7%) experienced adverse events. The trial was halted prematurely for adverse events. One patient had respiratory distress with full recovery with withdrawal. In an intention to treat analysis, the survival functions did not differ significantly between groups (Kaplan-Meier, log-rank 0.38). In a per protocol analysis,the survival function was better in comparison to the control group, with a mean survival of 14.72 months [95% CI 13.19- 16.25]), whereas, in the experimental group, the mean survival was 10.59 months [95% CI 7.12-14.07] (log-rank 0.04). For the secondary outcomes, there were no differences between the groups. Conclusions: There was low compliance, lack of effectiveness, a high incidence of adverse events and occurrence of respiratory distress with lithium carbonate in amyotrophic lateral sclerosis. Trial registration number: RBR-2n5mtq; date of trial registration: 2015-07-28.

Keywords: amyotrophic lateral sclerosis, motor neuron disease, lithium, survival, CMAP, motor unit, treatment, drug.

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