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Long-term safety an...
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
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Hufnagel, Andreas (author)
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- Ben-Menachem, Elinor, 1945 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi,Institute of Neuroscience and Physiology
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Gabbai, Alberto A. (author)
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Falcão, Amílcar (author)
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Almeida, Luis (author)
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Soares-da-Silva, Patricio (author)
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(creator_code:org_t)
- Elsevier BV, 2013
- 2013
- English.
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In: Epilepsy Research. - : Elsevier BV. - 0920-1211 .- 1872-6844. ; 103, s. 262-269
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Abstract
Subject headings
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- 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. © 2012 Elsevier B.V.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Neurovetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Neurosciences (hsv//eng)
Keyword
- Antiepileptics
- Depressive symptoms
- Eslicarbazepine acetate
- Long-term treatment
- Quality of life
Publication and Content Type
- ref (subject category)
- art (subject category)
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