계명대학교 의학도서관 Repository

Long-term effects of adjunctive eslicarbazepine acetate in adult Asian patients with refractory focal seizures: Post hoc analysis of a phase III trial

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Author(s)
Sang Kun LeeSang Ahm LeeSeung Bong HongYong Won ChoGuillermo Castilla-FernándezMiguel M FonsecaJoana MoreiraHelena GamaJoerg Holenz
Keimyung Author(s)
Cho, Yong Won
Department
Dept. of Neurology (신경과학)
Journal Title
Clin Transl Sci
Issued Date
2024
Volume
17
Abstract
A post hoc analysis of data from Asian patients included in the study BIA-2093-304 was conducted to evaluate the long-term safety/tolerability and efficacy of adjunctive eslicarbazepine acetate (ESL) in adult Asian patients with refractory focal seizures. Part I was a randomized controlled trial, in which patients received ESL (800 or 1200 mg once daily [QD]) or placebo, assessed over a 12-week maintenance period. Patients completing Part I could enter two open-label extension periods (Part II, 1 year; Part III, ≥2 years), during which all received ESL (400–1600 mg QD). Safety/tolerability was assessed by evaluating treatment-emergent adverse events (TEAEs). Efficacy assessments included responder and seizure freedom rates. The safety population included 125, 92, and 23 Asian patients in Parts I, II, and III, respectively. Incidence of ESL-related TEAEs was 61.3%, 45.7%, and 17.4% during Parts I, II, and III, respectively. ESL-related TEAEs (most commonly, dizziness, somnolence, and headache) were consistent with ESL's known safety profile. During Part I, responder rates were higher with ESL 800 (41.7%) and 1200 mg QD (44.4%) versus placebo (32.6%), although not statistically significant. Seizure freedom rates with ESL 800 (5.5%) and 1200 mg QD (11.1%) were also higher versus placebo (0%) (p < 0.05 for ESL 1200 mg QD versus placebo). At the end of Part II, responder and seizure freedom rates were 60.3% and 14.7%, respectively. In summary, adult Asian patients with refractory focal seizures were responsive to treatment with ESL as adjunctive therapy and generally showed treatment tolerance well for up to 3 years. No new/unexpected safety findings were observed.
Keimyung Author(s)(Kor)
조용원
Publisher
School of Medicine (의과대학)
Type
Article
ISSN
1752-8054
Source
https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.13802
DOI
10.1111/cts.13802
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/45782
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Neurology (신경과학)
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