Lithium Carbonate Not Found to Be Beneficial for ALS
Drug poorly tolerated in patients with both therapeutic and subtherapeutic blood levels
WEDNESDAY, Aug. 11 (HealthDay News) -- Lithium carbonate is ineffective as a treatment for amyotrophic lateral sclerosis (ALS) and has a high frequency of adverse effects, according to research published online Aug. 11 in Neurology.
Adriano Chiò, M.D., of AOU San Giovanni Battista & Università degli Studi di Torino in Italy, and colleagues conducted a multicenter, single-blind, randomized, dose-finding trial of lithium for the treatment of ALS. The trial was undertaken after recent research reported a neuroprotective effect of lithium in ALS. Enrolled patients were randomized to receive either a therapeutic dose or a subtherapeutic dose of lithium carbonate, as guided by blood levels.
Of the 171 patients enrolled, the researchers note that 117 dropped out of the study because of death, tracheotomy, severe disability, adverse events, or lack of efficacy. Patients in the therapeutic and subtherapeutic groups had similar results in survival, function, and disability. The trial was stopped early at the recommendation of the Data Monitoring Committee because of the high frequency of adverse effects, many of them severe.
"The study was stopped for futility. Patients with ALS in both groups died or lost their autonomy at the same rate (Class II evidence)," writes the author of an accompanying editorial. "In hindsight, an interim analysis rule based on a prespecified number of events, rather than on time, might have brought the study to an earlier close. Absence of a true placebo arm left open the possibility that therapeutic and subtherapeutic levels of lithium were equally ineffective, or made patients equally better or worse."
Several study authors disclosed financial or advisory relationships with the pharmaceutical industry.