No abstract

Recent controlled trials in outpatients with amyotrophic lateral sclerosis (ALS) indicate that riluzole prolongs tracheostomy-free survival. After 12 months' treatment, riluzole 50 mg, 100 mg and 200 mg daily reduced the risk of death or tracheostomy (relative to placebo) by 24%, 34% and 31%, respectively (by 28%, 43% and 43%, respectively, after adjustment for known prognostic factors). This survival advantage (6-9 patients require treatment with riluzole to avoid 1 death/tracheostomy annually) compares favourably with that achieved therapeutically in breast cancer and coronary artery disease. Some 6000 ALS patients are currently receiving riluzole 50 mg twice daily within the Riluzole Early Access Program. In France, this programme is being implemented as an open-label multicentre trial to assess patients' functional status and quality of life. To date, 844 patients have been enrolled, and they will be followed up for 12 months on riluzole. Baseline demographic and clinical characteristics of this study population are presented here.

The safety results with this broad population (over 10% of the estimated ALS population worldwide) were consistent with those previously reported from placebo-controlled trials. No increase in adverse events and no unexpected adverse events were observed.