THE RILUZOLE EARLY ACCESS PROGRAM - DESCRIPTIVE ANALYSIS OF 844 PATIENTS IN FRANCE

Recent controlled trials in outpatients with amyotrophic lateral scler osis (ALS) indicate that riluzole prolongs tracheostomy-free survival. After 12 months' treatment, riluzole 50 mg, 100 mg and 200 mg daily r educed the risk of death or tracheostomy (relative to placebo) by 24%, 34% and 31%, respectively (by 28%, 43% and 43%, respectively, after a djustment 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 b reast cancer and coronary artery disease. Some 6000 ALS patients are c urrently receiving riluzole 50 mg twice daily within the Riluzole Earl y Access Program. In France, this programme is being implemented as an open-label multicentre trial to assess patients' functional status an d quality of life. To date, 844 patients have been enrolled, and they will be followed up for 12 months on riluzole. Baseline demographic an d clinical characteristics of this study population are presented here .