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Titolo:
Stiripentol in severe myoclonic epilepsy in infancy: a randomised placebo-controlled syndrome-dedicated trial
Autore:
Chiron, C; Marchand, MC; Tran, A; Rey, E; dAthis, P; Vincent, J; Dulac, O; Pons, G;
Indirizzi:
Hop St Vincent de Paul, Serv Neuropediat, F-75674 Paris 14, France Hop St Vincent de Paul Paris France 14 opediat, F-75674 Paris 14, France Hop St Vincent de Paul, INSERM, U29, F-75674 Paris, France Hop St Vincent de Paul Paris France F-75674 , U29, F-75674 Paris, France Univ Paris 05, Paris, France Univ Paris 05 Paris FranceUniv Paris 05, Paris, France Biocodex, Montrouge, France Biocodex Montrouge FranceBiocodex, Montrouge, France Univ Hosp, Dijon, France Univ Hosp Dijon FranceUniv Hosp, Dijon, France
Titolo Testata:
LANCET
fascicolo: 9242, volume: 356, anno: 2000,
pagine: 1638 - 1642
SICI:
0140-6736(20001111)356:9242<1638:SISMEI>2.0.ZU;2-4
Fonte:
ISI
Lingua:
ENG
Soggetto:
LENNOX-GASTAUT-SYNDROME; NEWLY-DIAGNOSED EPILEPSY; DOUBLE-BLIND; CHILDREN; VIGABATRIN; CARBAMAZEPINE; LAMOTRIGINE; METABOLISM; VALPROATE; CHILDHOOD;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
25
Recensione:
Indirizzi per estratti:
Indirizzo: Chiron, C Hop St Vincent de Paul, Serv Neuropediat, 82 Ave Denfert Rochereau, F-75674 Paris 14, France Hop St Vincent de Paul 82 Ave Denfert Rochereau Paris France 14
Citazione:
C. Chiron et al., "Stiripentol in severe myoclonic epilepsy in infancy: a randomised placebo-controlled syndrome-dedicated trial", LANCET, 356(9242), 2000, pp. 1638-1642

Abstract

Background Stiripentol is an inhibitor of cytochrome P450 that showed antiepileptic efficacy in severe myoclonic epilepsy in infancy (SMEI) in association with clobazam and valproate in an open study. To confirm these results, 41 children with SMEI were included in a randomised, placebo-controlled,add-on trial. Methods After a baseline period of 1 month, placebo (n=20) or stiripentol (n=21) was added to valproate and clobazam during a double-blind period of 2 months. Patients then received stiripentol in an open fashion. Responderswere defined as having more than 50% reduction in the frequency of clonic (or tonic-clonic) seizures during the second month of the double-blind period compared with baseline. Findings 15 (71%) patients were responders on stiripentol (including nine free of clonic or tonic-clonic seizures), whereas there was only one (5%) on placebo (none were seizure free; stiripentol 95% CI 52.1-90.7 vs placebo 0-14.6). The 95% CI of the difference was 42.2-85.7. Percentage of change from baseline was higher on stiripentol (-69%) than on placebo (+7%), p<0.0001. 21 patients on stiripentol had moderate side-effects (drowsiness, loss of appetite) compared with eight on placebo, but side-effects disappeared when the dose of comedication was decreased in 12 of the 21 cases. Interpretation This controlled trial shows the antiepileptic efficacy, of add-on stiripentol in children with SMEI. The results also provide good reason to focus studies on a specific epilepsy syndrome-a small sample of patients is sufficient to show the efficacy that might have been missed in a heterogeneous population.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 30/11/20 alle ore 20:08:59