| 1. |
- Vogt, Viola Lara, et al.
(författare)
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Current standards of neuropsychological assessment in epilepsy surgery centers across Europe.
- 2017
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Ingår i: Epilepsia. - : Wiley. - 1528-1167 .- 0013-9580. ; 58:3, s. 343-355
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Tidskriftsartikel (refereegranskat)abstract
- We explored the current practice with respect to the neuropsychological assessment of surgical epilepsy patients in European epilepsy centers, with the aim of harmonizing and establishing common standards. Twenty-six epilepsy centers and members of "E-PILEPSY" (a European pilot network of reference centers in refractory epilepsy and epilepsy surgery), were asked to report the status of neuropsychological assessment in adults and children via two different surveys. There was a consensus among these centers regarding the role of neuropsychology in the presurgical workup. Strong agreement was found on indications (localization, epileptic dysfunctions, adverse drugs effects, and postoperative monitoring) and the domains to be evaluated (memory, attention, executive functions, language, visuospatial skills, intelligence, depression, anxiety, and quality of life). Although 186 different tests are in use throughout these European centers, a core group of tests reflecting a moderate level of agreement could be discerned. Variability exists with regard to indications, protocols, and paradigms for the assessment of hemispheric language dominance. For the tests in use, little published evidence of clinical validity in epilepsy was provided. Participants in the survey reported a need for improvement concerning the validity of the tests, tools for the assessment of everyday functioning and accelerated forgetting, national norms, and test co-normalization. Based on the present survey, we documented a consensus regarding the indications and principles of neuropsychological testing. Despite the variety of tests in use, the survey indicated that there may be a core set of tests chosen based on experience, as well as on published evidence. By combining these findings with the results of an ongoing systematic literature review, we aim for a battery that can be recommended for the use across epilepsy surgical centers in Europe.
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| 2. |
- Elger, Christian, et al.
(författare)
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Pooled efficacy and safety of eslicarbazepine acetate as add-on treatment in patients with focal-onset seizures: Data from four double-blind placebo-controlled pivotal phase III clinical studies
- 2017
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Ingår i: CNS Neuroscience and Therapeutics. - : Wiley. - 1755-5930 .- 1755-5949. ; 23, s. 961-972
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Tidskriftsartikel (refereegranskat)abstract
- © 2017 The Authors. CNS Neuroscience & Therapeutics Published by John Wiley & Sons Ltd. Purpose: Pooled evaluation of the key efficacy and safety profile of eslicarbazepine acetate (ESL) added-on to stable antiepileptic therapy in adults with focal-onset seizures. Methods: Data from 1703 patients enrolled in four phase III double-blind, randomized, placebo-controlled studies were pooled and analyzed. Following a 2week titration period, ESL was administered at 400mg, 800mg, and 1200mg once-daily doses for 12weeks (maintenance period). Pooled efficacy variable was standardized (/4weeks) seizure frequency (SSF) analyzed over the maintenance period as reduction in absolute and relative SSF and proportion of responders (≥50% reduction in SSF). Pooled safety was analyzed by means of adverse events and clinical laboratory assessments. Results: SSF was significantly reduced with ESL 800mg (P<0.0001) and 1200mg (P<0.0001) compared to placebo. Median relative reduction in SSF was 33.4% for ESL 800mg and 37.8% for 1200mg (placebo: 17.6%), and responder rate was 33.8% and 43.1% (placebo: 22.2%). ESL was more efficacious than placebo regardless of gender, geographical region, epilepsy duration, age at time of diagnosis, seizure type, and type of concomitant antiepileptic drugs (AED). Incidence of adverse events (AEs) and AEs leading to discontinuation was dose dependent. Most common AEs (>10% patients) were dizziness, somnolence, and nausea. The incidence of treatment-emergent AEs (dizziness, somnolence, ataxia, vomiting, and nausea) was lower in patients who began taking ESL 400mg (followed by 400mg increments to 800 or 1200mg) than in those who began taking ESL 600mg or 800mg. Conclusions: Once-daily ESL 800mg and 1200mg showed consistent results across all efficacy and safety endpoints, independent of study population characteristics and type of concomitant AEDs. Treatment initiated with ESL 400mg followed by 400mg increments to 800 or 1200mg provides optimal balance of efficacy and tolerability.
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