{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T10:26:37Z","timestamp":1788517597052,"version":"build-2803163510"},"reference-count":36,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2018,1,25]],"date-time":"2018-01-25T00:00:00Z","timestamp":1516838400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"BIAL-Portela & Ca"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2018,2]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>We assessed the efficacy and safety of once\u2010daily eslicarbazepine acetate in comparison with twice\u2010daily (<jats:styled-content style=\"fixed-case\">BID<\/jats:styled-content>) controlled\u2010release carbamazepine (carbamazepine\u2010<jats:styled-content style=\"fixed-case\">CR<\/jats:styled-content>) monotherapy in newly diagnosed focal epilepsy patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This randomized, double\u2010blind, noninferiority trial (<jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>01162460) utilized a stepwise design with 3 dose levels. Patients who remained seizure\u2010free for the 26\u2010week evaluation period (level A: eslicarbazepine acetate 800\u00a0mg\/carbamazepine\u2010<jats:styled-content style=\"fixed-case\">CR<\/jats:styled-content> 200\u00a0mg <jats:styled-content style=\"fixed-case\">BID<\/jats:styled-content>) entered a 6\u2010month maintenance period. If a seizure occurred during the evaluation period, patients were titrated to the next target level (level B: eslicarbazepine acetate 1200\u00a0mg\/carbamazepine\u2010<jats:styled-content style=\"fixed-case\">CR<\/jats:styled-content> 400\u00a0mg <jats:styled-content style=\"fixed-case\">BID<\/jats:styled-content>, level C: eslicarbazepine acetate 1600\u00a0mg\/carbamazepine\u2010<jats:styled-content style=\"fixed-case\">CR<\/jats:styled-content> 600\u00a0mg <jats:styled-content style=\"fixed-case\">BID<\/jats:styled-content>) and the evaluation period began again. The primary endpoint was the proportion of seizure\u2010free patients for 6\u00a0months after stabilization in the per protocol set. The predefined noninferiority criteria were \u221212% absolute and \u221220% relative difference between treatment groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Eight hundred fifteen patients were randomly assigned; 785 (388 in the eslicarbazepine acetate group and 397 in the carbamazepine\u2010<jats:styled-content style=\"fixed-case\">CR<\/jats:styled-content> group) were included in the per protocol set, and 813 (401 in the eslicarbazepine acetate group and 412 in the carbamazepine\u2010<jats:styled-content style=\"fixed-case\">CR<\/jats:styled-content> group) were included in the full analysis set for the primary analysis. Overall, 71.1% of eslicarbazepine acetate\u2013treated patients and 75.6% of carbamazepine\u2010CR\u2013treated patients were seizure\u2010free for \u22656\u00a0months at the last evaluated dose (average risk difference = \u22124.28%, 95% confidence interval [<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>] = \u221210.30 to 1.74; relative risk difference = \u22125.87%, 95%<jats:styled-content style=\"fixed-case\"> CI<\/jats:styled-content> = \u221213.50 to 2.44) in the per protocol set. Rates of treatment\u2010emergent adverse events were similar between groups for patients in the safety set. Noninferiority was also demonstrated in the full analysis set, as 70.8% of patients with eslicarbazepine acetate and 74.0% with carbamazepine\u2010<jats:styled-content style=\"fixed-case\">CR<\/jats:styled-content> were seizure\u2010free at the last evaluated dose (<jats:styled-content style=\"fixed-case\">average risk difference<\/jats:styled-content> = \u22123.07, 95% <jats:styled-content style=\"fixed-case\">CI =<\/jats:styled-content> \u22129.04 to 2.89).<\/jats:p><\/jats:sec><jats:sec><jats:title>Significance<\/jats:title><jats:p>Treatment with eslicarbazepine acetate was noninferior to BID carbamazepine\u2010<jats:styled-content style=\"fixed-case\">CR<\/jats:styled-content>. With its once\u2010daily formulation, eslicarbazepine acetate provides a useful option for first\u2010line monotherapy for adults with newly diagnosed epilepsy and focal onset seizures.<\/jats:p><\/jats:sec>","DOI":"10.1111\/epi.13993","type":"journal-article","created":{"date-parts":[[2018,1,25]],"date-time":"2018-01-25T15:08:48Z","timestamp":1516892928000},"page":"479-491","source":"Crossref","is-referenced-by-count":84,"title":["Efficacy and safety of eslicarbazepine acetate versus controlled\u2010release carbamazepine monotherapy in newly diagnosed epilepsy: A phase <scp>III<\/scp> double\u2010blind, randomized, parallel\u2010group, multicenter study"],"prefix":"10.1111","volume":"59","author":[{"given":"Eugen","family":"Trinka","sequence":"first","affiliation":[{"name":"Department of Neurology Christian Doppler Medical Center Paracelsus Medical University Salzburg Salzburg Austria"},{"name":"Center for Cognitive Neuroscience Salzburg Austria"},{"name":"Department of Public Health and Health Technology Assessment University for Health Sciences, Medical Informatics, and Technology Hall in Tirol Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elinor","family":"Ben\u2010Menachem","sequence":"additional","affiliation":[{"name":"Institute for Clinical Neuroscience and Physiology Sahlgrenska Academy University of Gothenburg Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro A.","family":"Kowacs","sequence":"additional","affiliation":[{"name":"Neurological Institute of Curitiba Curitiba Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Elger","sequence":"additional","affiliation":[{"name":"Department of Epileptology University of Bonn Bonn Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Birgit","family":"Keller","sequence":"additional","affiliation":[{"name":"Accovion\/Clinipace Worldwide Eschborn Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kurt","family":"L\u00f6ffler","sequence":"additional","affiliation":[{"name":"Accovion\/Clinipace Worldwide Eschborn Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 Francisco","family":"Rocha","sequence":"additional","affiliation":[{"name":"Department of Research and Development BIAL\u2010Portela &amp; C<sup>a<\/sup> S.A. 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