German open label trial of riluzole 50 mg b.i.d. in treatment of amyotrophic lateral sclerosis (ALS)

Riluzole is currently the only drug that holds any hope of prolonging life in amyotrophic lateral sclerosis (ALS) by slowing the rate of disease progr ession. Methods and results: Between 1995 and 1997 a total of 7916 ALS pati ents in 39 countries, were given 100 mg riluzole per day for a mean of 7.2 months. The present report focuses on the German results in comparison to t he total population. Nine hundred and nineteen patients were treated in 25 German centres: 162 (17.6%) died from the disease during the course of the study. Serious adverse events attributed to the study medication occurred i n 16 patients (1.7%). Most frequently these were reversible changes in live r enzymes (0.9%) occurring during the first 3 months, none resulted in deat h. In all, 413 patients (44.9%) reported an adverse event. The most frequen t were reduced lung function (7.3%), nausea (7.1%), asthenia (5.8%), pneumo nia (2.5%) and abdominal pain (2.5%). Conclusion: The results of the study allow the conclusion that riluzole is well tolerated. The majority of adver se events were symptoms of the underlying disease and were not attributed t o riluzole. Overall the safety profile found in the German centres was very similar to the profile seen in the total patient population and was more f avourable than in the two published double-blind studies [New Engl J Med 33 0 (1994) 585. Lancet 347 (1996) 1425]. (C) 2000 Elsevier Science B.V. All r ights reserved.