KOMET: an unblinded, randomised, two parallel-group, stratified trial comparing the effectiveness of levetiracetam with controlled-release carbamazepine and extended-release sodium valproate as monotherapy in patients with newly diagnosed epilepsy

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00843989%3A_____%2F13%3AE0103556" target="_blank" >RIV/00843989:_____/13:E0103556 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1136/jnnp-2011-300376" target="_blank" >http://dx.doi.org/10.1136/jnnp-2011-300376</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1136/jnnp-2011-300376" target="_blank" >10.1136/jnnp-2011-300376</a>

Jazyk výsledku

angličtina

Název v původním jazyce

KOMET: an unblinded, randomised, two parallel-group, stratified trial comparing the effectiveness of levetiracetam with controlled-release carbamazepine and extended-release sodium valproate as monotherapy in patients with newly diagnosed epilepsy

Popis výsledku v původním jazyce

Objective: To compare the effectiveness of levetiracetam (LEV) with extended-release sodium valproate (VPA-ER) and controlled-release carbamazepine (CBZ-CR) as monotherapy in patients with newly diagnosed epilepsy. Methods: This unblinded, randomised, 52-week superiority trial (NCT00175903) recruited patients (16years of age) with 2 unprovoked seizures in the previous 2years and 1 in the previous 6months. The physician chose VPA or CBZ as preferred standard treatment; each patient was randomised to standard treatment or LEV. The primary outcome was time to treatment withdrawal (LEV vs standard antiepileptic drugs (AEDs)). Analyses also compared LEV with VPA-ER, and LEV with CBZ-CR. Findings: 1688 patients (mean age 41years; 44% female) were randomisedto LEV (n=841) or standard AEDs (n=847). Time to treatment withdrawal was not significantly different between LEV and standard AEDs: HR (95% CI) 0.90 (0.74 to 1.08). Time to treatment withdrawal (HR (95% CI)) was 1.02 (0.74 to 1.41) for L

Název v anglickém jazyce

KOMET: an unblinded, randomised, two parallel-group, stratified trial comparing the effectiveness of levetiracetam with controlled-release carbamazepine and extended-release sodium valproate as monotherapy in patients with newly diagnosed epilepsy

Popis výsledku anglicky

Objective: To compare the effectiveness of levetiracetam (LEV) with extended-release sodium valproate (VPA-ER) and controlled-release carbamazepine (CBZ-CR) as monotherapy in patients with newly diagnosed epilepsy. Methods: This unblinded, randomised, 52-week superiority trial (NCT00175903) recruited patients (16years of age) with 2 unprovoked seizures in the previous 2years and 1 in the previous 6months. The physician chose VPA or CBZ as preferred standard treatment; each patient was randomised to standard treatment or LEV. The primary outcome was time to treatment withdrawal (LEV vs standard antiepileptic drugs (AEDs)). Analyses also compared LEV with VPA-ER, and LEV with CBZ-CR. Findings: 1688 patients (mean age 41years; 44% female) were randomisedto LEV (n=841) or standard AEDs (n=847). Time to treatment withdrawal was not significantly different between LEV and standard AEDs: HR (95% CI) 0.90 (0.74 to 1.08). Time to treatment withdrawal (HR (95% CI)) was 1.02 (0.74 to 1.41) for L

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FH - Neurologie, neurochirurgie, neurovědy

OECD FORD obor

—

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2013

Kód důvěrnosti údajů

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

Název periodika

Journal of Neurology, Neurosurgery and Psychiatry

ISSN

0022-3050

e-ISSN

—

Svazek periodika

84

Číslo periodika v rámci svazku

n. 10

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

10

Strana od-do

"p. 1138-1147"

Kód UT WoS článku

000323779800017

EID výsledku v databázi Scopus

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