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At the end of the study after median followup of 18 months,122(50.4%) placebo-treated patients and 134(56.8%)of those who received 100 mg/day riluzole were alive without tracheostomy(unadjusted risk 0.79,p=0.076; adjusted risk 0.65,p-0.002).In the groups receiving 50 mg and 200 mg riluzone daily,131(55.3%)and 141(57.8%)patients were alive without tracheostomy(relative to placebo 50 mg adjusted risk 0.76,p=0,94l 299 ng 9,52m p=0,0004).There was a significant inverse dose response in risk of death.No functional scale discriminated between the treatment groups.The most common adverse reactions were asthenia,dizziness,gastrointestinal disorders,and rises in liver enzyme activities;they were commonest with the 200 mg dose.Overall,efficacy and safety results suggest that the 100 mg dose of riluzole has the best benefit-to-risk ratio.This study confirms that riluzole is well tolerated and lengthens survival of patients with ALS. |
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