British journal of clinical pharmacology · 2011
Riluzole pharmacokinetics in young patients with spinal muscular atrophy.
Клиническое исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Abbara Chadi, Estournet Brigitte, Lacomblez Lucette, Lelièvre Benedicte, Ouslimani Amal, Lehmann Blandine, Viollet Louis, Barois Annie, Diquet Bertrand
Аннотация
AIMS: The objective of the present study was to assess the pharmacokinetics of riluzole in patients with spinal muscular atrophy (SMA).
METHODS: Fourteen patients were enrolled in an open-label, nonrandomized and repeat-dose pharmacokinetic study. All participants were assigned to receive 50mg riluzole orally for 5 days. Riluzole plasma concentrations were determined from samples obtained at day 5.
RESULTS: The pharmacokinetic analysis demonstrated that a dose of 50mg once a day was sufficient to obtain a daily total exposure [AUC(0,24h)=2257ng ml(-1) h] which was comparable with results obtained in adult healthy volunteers or ALS patients in whom a dose of 50mg twice a day is recommended. The pharmacokinetic simulation demonstrated that the administration of 50mg twice a day could result in higher concentrations, hence reduced safety margin.
CONCLUSION: The dose of 50mg once a day was chosen for the clinical trial evaluating the efficacy of riluzole in SMA patients.
METHODS: Fourteen patients were enrolled in an open-label, nonrandomized and repeat-dose pharmacokinetic study. All participants were assigned to receive 50mg riluzole orally for 5 days. Riluzole plasma concentrations were determined from samples obtained at day 5.
RESULTS: The pharmacokinetic analysis demonstrated that a dose of 50mg once a day was sufficient to obtain a daily total exposure [AUC(0,24h)=2257ng ml(-1) h] which was comparable with results obtained in adult healthy volunteers or ALS patients in whom a dose of 50mg twice a day is recommended. The pharmacokinetic simulation demonstrated that the administration of 50mg twice a day could result in higher concentrations, hence reduced safety margin.
CONCLUSION: The dose of 50mg once a day was chosen for the clinical trial evaluating the efficacy of riluzole in SMA patients.