Prevention of epilepsy in infants with Tuberous Sclerosis Complex in the EPISTOP trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064203%3A_____%2F21%3A10417598" target="_blank" >RIV/00064203:_____/21:10417598 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11130/21:10417598

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=7pZMYhydEw" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=7pZMYhydEw</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1002/ana.25956" target="_blank" >10.1002/ana.25956</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Prevention of epilepsy in infants with Tuberous Sclerosis Complex in the EPISTOP trial

Popis výsledku v původním jazyce

OBJECTIVE: Epilepsy develops in 70-90% of children with Tuberous Sclerosis Complex (TSC) and is often resistant to medication. Recently, the concept of preventive antiepileptic treatment to modify the natural history of epilepsy has been proposed. EPISTOP was a clinical trial designed to compare preventive versus conventional antiepileptic treatment in TSC infants. METHODS: In this multi-center study, 94 infants with TSC without seizure history were followed with monthly video electroencephalography (EEG), and received vigabatrin either as conventional antiepileptic treatment, started after the first electrographic or clinical seizure, or preventively when epileptiform EEG activity before seizures was detected. At six sites, subjects were randomly allocated to treatment in a 1:1 ratio in a randomized controlled trial (RCT). At four sites, treatment allocation was fixed, denoted an open-label trial (OLT). Subjects were followed until 2 years of age. The primary endpoint was the time to first clinical seizure. RESULTS: In 54 subjects epileptiform EEG abnormalities were identified before seizures. Twenty-seven were included in the RCT and 27 in the OLT. The time to the first clinical seizure was significantly longer with preventive than conventional treatment (RCT: 364 95% CI: 223, 535) vs. 124 days (95% CI: 33, 149); OLT: 426 (95% CI: 258, 628) vs. 106 days (95% CI: 11, 149). At 24 months, our pooled analysis showed preventive treatment reduced the risk of clinical seizures (odds ratio [OR] = 0.21, p = 0.032), drug-resistant epilepsy (OR = 0.23, p = 0.022), and infantile spasms (OR = 0, p &lt; 0.001). No adverse events related to preventive treatment were noted. INTERPRETATION: Preventive treatment with vigabatrin was safe and modified the natural history of seizures in TSC, reducing the risk and severity of epilepsy. This article is protected by copyright. All rights reserved.

Název v anglickém jazyce

Prevention of epilepsy in infants with Tuberous Sclerosis Complex in the EPISTOP trial

Popis výsledku anglicky

OBJECTIVE: Epilepsy develops in 70-90% of children with Tuberous Sclerosis Complex (TSC) and is often resistant to medication. Recently, the concept of preventive antiepileptic treatment to modify the natural history of epilepsy has been proposed. EPISTOP was a clinical trial designed to compare preventive versus conventional antiepileptic treatment in TSC infants. METHODS: In this multi-center study, 94 infants with TSC without seizure history were followed with monthly video electroencephalography (EEG), and received vigabatrin either as conventional antiepileptic treatment, started after the first electrographic or clinical seizure, or preventively when epileptiform EEG activity before seizures was detected. At six sites, subjects were randomly allocated to treatment in a 1:1 ratio in a randomized controlled trial (RCT). At four sites, treatment allocation was fixed, denoted an open-label trial (OLT). Subjects were followed until 2 years of age. The primary endpoint was the time to first clinical seizure. RESULTS: In 54 subjects epileptiform EEG abnormalities were identified before seizures. Twenty-seven were included in the RCT and 27 in the OLT. The time to the first clinical seizure was significantly longer with preventive than conventional treatment (RCT: 364 95% CI: 223, 535) vs. 124 days (95% CI: 33, 149); OLT: 426 (95% CI: 258, 628) vs. 106 days (95% CI: 11, 149). At 24 months, our pooled analysis showed preventive treatment reduced the risk of clinical seizures (odds ratio [OR] = 0.21, p = 0.032), drug-resistant epilepsy (OR = 0.23, p = 0.022), and infantile spasms (OR = 0, p &lt; 0.001). No adverse events related to preventive treatment were noted. INTERPRETATION: Preventive treatment with vigabatrin was safe and modified the natural history of seizures in TSC, reducing the risk and severity of epilepsy. This article is protected by copyright. All rights reserved.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30103 - Neurosciences (including psychophysiology)

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2021

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Annals of Neurology

ISSN

0364-5134

e-ISSN

—

Svazek periodika

89

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

11

Strana od-do

304-314

Kód UT WoS článku

000592500500001

EID výsledku v databázi Scopus

2-s2.0-85096638206