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

Autor: Sang Kun Lee, Sang Ahm Lee, Seung Bong Hong, Yong Won Cho, Guillermo Castilla‐Fernández, Miguel M. Fonseca, Joana Moreira, Helena Gama, Joerg Holenz
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Clinical and Translational Science, Vol 17, Iss 5, Pp n/a-n/a (2024)
Druh dokumentu: article
ISSN: 1752-8062
1752-8054
DOI: 10.1111/cts.13802
Popis: 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
Databáze: Directory of Open Access Journals
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje