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)

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

Article/chapterEnglish2013

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Elsevier BV,2013

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LIBRIS-ID:oai:gup.ub.gu.se/273288
https://gup.ub.gu.se/publication/273288URI
https://doi.org/10.1016/j.eplepsyres.2012.07.014DOI

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Language:English

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Subject category:art swepub-publicationtype

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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 and genre

MEDICIN OCH HÄLSOVETENSKAP Medicinska och farmaceutiska grundvetenskaper Neurovetenskaper hsv//swe
MEDICAL AND HEALTH SCIENCES Basic Medicine Neurosciences hsv//eng
Antiepileptics
Depressive symptoms
Eslicarbazepine acetate
Long-term treatment
Quality of life

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Ben-Menachem, Elinor,1945Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi,Institute of Neuroscience and Physiology(Swepub:gu)xbenel (author)
Gabbai, Alberto A. (author)
Falcão, Amílcar (author)
Almeida, Luis (author)
Soares-da-Silva, Patricio (author)
Göteborgs universitetInstitutionen för neurovetenskap och fysiologi (creator_code:org_t)

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In:Epilepsy Research: Elsevier BV103, s. 262-2690920-12111872-6844

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