Adjunctive lamotrigine XR for primary generalized tonic–clonic seizures in a randomized, placebo-controlled study
2010; Elsevier BV; Volume: 19; Issue: 3 Linguagem: Inglês
10.1016/j.yebeh.2010.07.022
ISSN1525-5069
AutoresVictor Biton, Juan Di Memmo, Rakesh Shukla, Yeong Yeh Lee, И. Е. Повереннова, Vladislav Demchenko, Jane Saiers, Bryan Adams, Anne E. Hammer, Alain Vuong, John A. Messenheimer,
Tópico(s)Hemoglobinopathies and Related Disorders
ResumoAbstract Efficacy and tolerability of once-daily adjunctive lamotrigine extended-release (XR) for primary generalized tonic–clonic (PGTC) seizures in epilepsy were evaluated. Patients ( n =153)≥13years old diagnosed with epilepsy with PGTC seizures were randomized to once-daily adjunctive lamotrigine XR or placebo in a double-blind, parallel-group trial comprising a baseline phase, a 7-week double-blind escalation phase, and a 12-week double-blind maintenance phase. Lamotrigine XR was more effective than placebo with respect to median percentage reduction from baseline in weekly PGTC seizure frequency (primary endpoint—19-week treatment phase: 75.4% vs 32.1%, P <0.0001; escalation phase: 61.9% vs 30.6%, P =0.0016; maintenance phase: 89.7% vs 33.3%, P 0.0001). Lamotrigine XR was more effective than placebo with respect to the percentage of patients with ≥50% reduction in PGTC seizure frequency. Significant separation from placebo for ≥50% reduction in PGTC seizures was observed beginning on treatment day 8. The most common adverse event was headache (lamotrigine XR 14%, placebo 16%).
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