The Rilutek ® (riluzole) Global Early Access Programme: An open-label safety evaluation in the treatment of amyotrophic lateral sclerosis

Abstract

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.

Adherence to riluzole in patients with amyotrophic lateral sclerosis: An observational study

“…7 Our findings disagree with the technical data sheet of riluzole 28 that reports oral paresthesia generally in a low percentage of patients (1.6%), reflecting the frequency of SE obtained in clinical trials and observational studies. 2,3,[8][9][10] Furthermore, in our study, the frequencies of liver function abnormalities, asthenia and nausea were relatively low, with respect to other reports. 2,3,8 In 4 out of 45 patients (8.9%), the SEs were responsible for a permanent riluzole interruption.…”

“…This percentage was lower than the discontinuation rates reported in randomized studies 2,3 and quite similar to that in observational studies. [8][9][10] Although low, this percentage may be remarkable considering that riluzole is one of the few therapies approved for this disease, unlike other diseases as multiple sclerosis in which several drugs of almost equal efficacy are available. 29 Another finding of our study is that the polypharmacy did not influence the adherence to riluzole.…”

“…7 Previous studies explored the safety and tolerability of riluzole therapy in patients who have been included in one of the two international, multicenter, randomized, double-blind, placebo-controlled trials 8 or who have not been eligible for clinical trials but had access to drug, while it was under the review of regulatory agencies. 9 The overall tolerability of riluzole was good, and the treatment was indicated for all patients with ALS, except for those with hepatic disease and/or who had an increase in transaminase (.3, the upper limit). 10 An important worldwide public health problem in the management of chronic diseases is the medication adherence and persistence.…”

Disease‐modifying drug therapies

“…[10][11][12][13] However, after the clinical trials and the open label studies, clinic and population-based databases led to questions concerning the use of riluzole in the community. These were examined by the King's College Motor Neuron Disease Clinic and the Ireland population-based Motor Neuron Disease Registry.…”

Recent advances in amyotrophic lateral sclerosis research

“…The long-term safety of riluzole therapy has been established [19,20], including use by elderly patients and those in advanced stages of the disease [21]. According to the Cochrane database, meta-analysis of three controlled, randomized trials with riluzole showed that the mean prolongation of survival in ALS is 2 months [22].…”