Riluzole pharmacokinetics in young patients with spinal muscular atrophy.
Br J Clin Pharmacol
; 71(3): 403-10, 2011 Mar.
Article
em En
| MEDLINE
| ID: mdl-21284699
ABSTRACT
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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Atrofia Muscular Espinal
/
Fármacos Neuroprotetores
/
Riluzol
Idioma:
En
Ano de publicação:
2011
Tipo de documento:
Article