{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T03:26:52Z","timestamp":1788319612699,"version":"build-2803163510"},"reference-count":36,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2016,6,6]],"date-time":"2016-06-06T00:00:00Z","timestamp":1465171200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100005032","name":"Funda\u00e7\u00e3o Bial","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005032","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003769","name":"Eisai","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003769","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004336","name":"Novartis","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004336","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2016,7]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To report pooled safety\/tolerability and seizure outcome data from adults with uncontrolled partial\u2010onset (focal) seizures (POS) receiving adjunctive brivaracetam (BRV) during phase IIb\/III and long\u2010term follow\u2010up (LTFU) studies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Seizure outcome data were pooled from phase IIb (NCT00175929 and NCT00175825), III\/IIIb (NCT00490035, NCT00464269, NCT00504881, and NCT01261325) and associated LTFU studies (NCT00175916, NCT00150800, and NCT01339559). Safety\/tolerability data were pooled from these studies plus NCT01405508, NCT01653262, and NCT01728077 (LTFU). Patients received placebo (during core studies) or BRV 5\u2013200 mg\/day. Safety\/tolerability and seizure outcomes (BRV modal doses 50\u2013200 mg\/day) were assessed until January 17, 2014.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 2,186 patients (97.3% with POS and 2.7% with other seizure types) who received BRV 50\u2013200 mg\/day, 2,051 (93.8%) completed core studies and continued in LTFU studies. Total BRV exposure: 5,339.4 patient\u2010years (\u22658.0 years in 41 patients); 6\u2010, 12\u2010, 24\u2010, and 60\u2010month retention: 91.0%, 79.8%, 68.1%, and 54.4%, respectively. Safety\/tolerability data pooled from 2,186 patients: \u22651 treatment\u2010emergent adverse event (TEAE) reported by 1,848 (84.5%) patients; 1,184 (54.2%) reported \u22651 TEAE considered treatment\u2010related. Most frequent TEAEs (\u226510%): headache (20.9%), dizziness (17.5%), somnolence (15.2%), nasopharyngitis (13.2%), fatigue (11.3%), and convulsion (10.6%). Serious TEAEs (SAEs) and treatment\u2010related SAEs: 401 (18.3%) and 95 (4.3%) patients, respectively. Of 28 (1.3%) deaths, four (14.3%) were considered possibly treatment related by the investigator. Pooled seizure outcome data (1,836 patients): median POS frequency\/28 days at baseline was 8.9; on treatment, median percentage reduction from baseline in POS\/28 days was 48.8%, and \u226550% responder rate was 48.7%. Complete seizure freedom: 4.9%, 4.2%, 3.0%, and 3.3% for \u22656, 12, 24, and 60 months, respectively. Improvements were seen in health\u2010related quality of life (HRQoL) from baseline, assessed by Quality of Life in Epilepsy Inventory\u201031.<\/jats:p><\/jats:sec><jats:sec><jats:title>Significance<\/jats:title><jats:p>Adjunctive BRV treatment in adults with POS was effective and generally well tolerated when administered long\u2010term (\u22658.0 years). Retention was high and HRQoL improvements were observed.<\/jats:p><\/jats:sec>","DOI":"10.1111\/epi.13416","type":"journal-article","created":{"date-parts":[[2016,6,6]],"date-time":"2016-06-06T05:56:48Z","timestamp":1465192608000},"page":"1139-1151","source":"Crossref","is-referenced-by-count":70,"title":["Safety, tolerability, and seizure control during long\u2010term treatment with adjunctive brivaracetam for partial\u2010onset seizures"],"prefix":"10.1111","volume":"57","author":[{"given":"Manuel","family":"Toledo","sequence":"first","affiliation":[{"name":"Vall d'Hebron University Hospital Independent University of Barcelona Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Whitesides","sequence":"additional","affiliation":[{"name":"UCB Pharma Raleigh North Carolina U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jimmy","family":"Schiemann","sequence":"additional","affiliation":[{"name":"UCB Pharma Raleigh North 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