Navegando por Palavras-chave "Eslicarbazepine acetate"

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    Efficacy 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 Aveiro
    Purpose: 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.
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    Eslicarbazepine 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 Porto
    Objective: 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.
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    Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: Results of a 1-year open-label extension study
    (Elsevier B.V., 2013-02-01) Hufnagel, Andreas; Ben-Menachem, Elinor; Gabbai, Alberto Alain [UNIFESP]; Falcao, Amilcar; Almeida, Luis; Soares-da-Silva, Patricio; BIA-2093-302 Investigators Study; Univ Essen Gesamthsch; Sahlgrens Univ Hosp; Universidade Federal de São Paulo (UNIFESP); Univ Coimbra; 4Hlth Consulting; Univ Aveiro; BIAL Portela & Ca SA; Univ Porto
    Objective: To evaluate the long-term safety, tolerability and efficacy of once-daily eslicarbazepine acetate (ESL) as adjunctive therapy in adults with partial-onset seizures.Methods: One-year open-label extension (OLE) study with ESL in patients who completed a randomised, double-blind placebo-controlled trial (study BIA-2093-302; Epilepsy Res. 89 (2010) 278-285). Starting dose was 800 mg once-daily, for 4 weeks; thereafter, dose could be individualised within the 400-1200 mg range. Doses of concomitant antiepileptic drugs were to be kept stable.Results: Overall, 325 patients were enrolled (intent-to-treat population); 223 (68.6%) patients completed 1-year of treatment. ESL median dose was 800 mg once-daily. Compared to the baseline period of the double-blind study completed prior to this OLE study, median seizure frequency decreased by 32% in weeks 1-4, and between 37% and 39% thereafter. the responder rate (seizure reduction >= 50%) was 37% during weeks 1-4 and thereafter ranged between 38% and 42% per 12-week interval. Proportion of seizure-free patients per 12-week interval ranged between 5% and 11%. Improvements from baseline in several Quality of Life in Epilepsy Inventory-31 (QOLIE-31) and Montgomery Asberg Depression Rating Scale (MADRS) scores were observed. Adverse events (AEs) were reported by 83% of patients. AEs occurring in >= 10% of patients were dizziness, headache and somnolence. AEs were usually of mild to moderate intensity.Conclusion: in this study, ESL demonstrated a sustained therapeutic effect and was well tolerated during 1-year add-on treatment of adults with partial-onset seizures. Additionally, significant improvements in quality of life domains and depressive symptoms were observed under long-term treatment with once-daily ESL. (c) 2012 Elsevier B.V. All rights reserved.