Navegando por Palavras-chave "Partial-onset seizures"
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- ItemSomente MetadadadosEfficacy and safety of eslicarbazepine acetate as add-on treatment in patients with focal-onset seizures: Integrated analysis of pooled data from double-blind phase III clinical studies(Wiley-Blackwell, 2013-01-01) Gil-Nagel, Antonio; Elger, Christian; Ben-Menachem, Elinor; Halasz, Peter; Lopes-Lima, Jose; Gabbai, Alberto Alain [UNIFESP]; Nunes, Teresa; Falcao, Amilcar; Almeida, Luis; Soares-da-Silva, Patricio; Hospital Ruber Internacional; University of Bonn; Sahlgrenska University Hospital; Institute for Experimental Medical Research; Universidade do Porto; Universidade Federal de São Paulo (UNIFESP); BIAL Portela & Ca SA; 4Health; Universidade de Coimbra; Universidade de AveiroPurpose: To evaluate the efficacy and safety profile of eslicarbazepine acetate (ESL) added to stable antiepileptic therapy in adults with partial-onset seizures. Methods: Data from 1,049 patients enrolled from 125 centers, in 23 countries, in three phase III double-blind, randomized, placebo-controlled studies were pooled and analyzed. Following a 2-week titration period, ESL was administered at 400 mg, 800 mg, and 1,200 mg once-daily doses for 12 weeks. Key Findings: Seizure frequency was significantly reduced with ESL 800 mg (p < 0.0001) and 1,200 mg (p < 0.0001) compared to placebo. Median relative reduction in seizure frequency was, respectively, 35% and 39% (placebo 15%) and responder rate was 36% and 44% (placebo 22%). ESL was more efficacious than placebo regardless of gender, geographic region, epilepsy duration, age at time of diagnosis, seizure type, and number and type of concomitant antiepileptic drugs (AEDs). Incidence of adverse events (AEs) and AEs leading to discontinuation were dose dependent. AEs occurred mainly during the first weeks of treatment, with no difference between groups after 6 weeks. Most common AEs (>10% patients) were dizziness, somnolence, and headache. the incidence of AEs in ESL groups compared to placebo was generally consistent among different subpopulations. Significance: Once-daily ESL 800 mg and 1,200 mg showed consistent results across all efficacy and safety end points. Results were independent of study population characteristics and type and number of concomitant AEDs.
- ItemSomente MetadadadosEslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy(Elsevier B.V., 2010-05-01) Ben-Menachem, E.; Gabbai, Alberto Alain [UNIFESP]; Hufnagel, A.; Maia, J.; Almeida, L.; Soares-da-Silva, P.; Sahlgrens Univ Hosp; Universidade Federal de São Paulo (UNIFESP); Univ Essen Gesamthsch; BIAL Portela & Co; Univ Aveiro; Univ PortoObjective: To investigate the efficacy and safety of once-daily eslicarbazepine acetate (ESL) when used as add-on treatment in adults with >= 4 partial-onset seizures per 4-week despite treatment with 1 to 3 antiepileptic drugs (AEDs).Methods: This double-blind, parallel-group, multicenter study consisted of an 8-week observational baseline period, after which patients were randomized to placebo (n=100) or once-daily ESL 400 mg (n = 96), 800 mg (n=101), or 1200 mg (n=98). Patients then entered a 14-week double-blind treatment phase. All patients started on their full maintenance dose except for those in the ESL 1200 mg group who received once-daily ESL 800 mg for 2 weeks before reaching their full maintenance dose.Results: Seizure frequency per 4-week (primary endpoint) over the 14-week double-blind treatment period was significantly lower than placebo in the ESL 800 mg and 1200 mg (p < 0.001) groups. Responder rate (>= 50% reduction in seizure frequency) was 13.0% (placebo), 16.7% (400 mg), 40.0% (800 mg, p < 0.001), and 37.1% (1200 mg, p<0.001). Median relative reduction in seizure frequency was 0.8% (placebo), 18.7% (400 mg), 32.6% (800 mg, p < 0.001), and 32.8% (1200 mg). Discontinuation rates due to adverse events (AEs) were 3.0% (placebo), 12.5% (400 mg), 18.8% (800 mg), and 26.5% (1200 mg). the most common (>5%) AEs in any group were dizziness, somnolence, headache, nausea, diplopia, abnormal coordination, vomiting, blurred vision, and fatigue. the majority of AEs were of mild or moderate severity.Conclusions: Treatment with once-daily eslicarbazepine acetate 800 mg and 1200 mg was more effective than placebo and generally well tolerated in patients with partial-onset seizures refractory to treatment with 1 to 3 concomitant AEDs. (C) 2010 Elsevier B.V. All rights reserved.