Lithium Not Found to Slow ALS Disease Progression
Study stopped when evidence suggested riluzole plus lithium would not be effective
WEDNESDAY, April 7 (HealthDay News) -- Despite the results of a recent pilot study that found lithium might dramatically slow progression of amyotrophic lateral sclerosis (ALS), the addition of lithium to riluzole in ALS patients does not appear to slow disease progression more than riluzole alone, according to a larger study published online April 6 in The Lancet Neurology.
Swati P. Aggarwal, M.D., of the Massachusetts General Hospital in Charlestown, and colleagues analyzed data from 84 patients with ALS who were taking a stable dose of riluzole. Patients were randomly assigned to also receive lithium or placebo. The primary end point was time to an event, defined as death or a decrease of at least six points from baseline on the revised ALS functional rating scale score.
The researchers write that the study was halted at the first interim analysis due to futility, at which point an event had occurred in 22 of 40 patients in the lithium group and 20 of 44 in the placebo group. The difference in mean decline in the ALS score between the groups was 0.15. There were no major safety concerns, but falls and back pain were more common in the lithium group.
"In conclusion, this randomized, double-blind, placebo-controlled trial failed to show a significant slowing of disease progression in patients with ALS treated with lithium. Whether smaller beneficial effects of lithium in ALS are still possible and whether compounds that target induction of autophagy have therapeutic potential in this disease needs to be assessed in future studies. At this time, there remains no convincing evidence for the use of lithium as a treatment for patients with ALS," the authors write.