Efficacy and safety of eslicarbazepine acetate monotherapy for partial-onset seizures: Experience from a multicenter, observational study
Por:
Toledano R, Jovel CE, Jiménez-Huete A, Bayarri PG, Campos D, Gomariz EL, Giráldez BG, García-Morales I, Falip M, Agredano PM, Palao S, Prior MJAA, Pascual MRQ, Navacerrada FJ, González FJL, Ojeda J, Sáez AA, Bermejo PE and Gil-Nagel A
Publicada:
1 ago 2017
Ahead of Print:
19 jun 2017
Resumen:
Eslicarbazepine acetate (ESL, Aptiom (TM)) is a once-daily anticonvulsant, approved as adjunctive treatment of partial-onset seizures (POS). Historical-controlled trials investigating the use of ESL as monotherapy have demonstrated a favorable efficacy and tolerability profile in patients with POS. This prospective, non-interventional study recruited POS patients in 17 hospitals in Spain. After a 3-month baseline period, ESL therapy was initiated as 400 mg QD and up-titrated to an optimal maintenance dose based on clinical response and tolerance. The incidence of seizures was assessed via seizure calendars and the nature and severity of adverse events (AEs) were also recorded. A total of 117 patients (aged 9-87 years) enrolled in the study and were treated with ESL at either 400 mg/day (3.4% patients), 800 mg/day (61% patients), 1200 mg/day (27.1% patients) or 1600 mg/day (8.5% patients). At 3 months, 82.0% (n = 72) of patients achieved a >= 50% reduction in seizure frequency, compared to 79.7% (n = 67) of patients at 6 months and 83.0% (n = 49) at 12 months. Patients who suffered secondary generalized tonic-clonic (SGTC) seizures had seizure-free rates of 71% (n = 27), 69.6% (n = 29), and 72.7% (n = 16) at 3, 6, and 12 months, respectively. Overall, 18 patients (153%) reported AEs of instability and dizziness (n = 9), somnolence (n = 3), mild hyponatremia (n = 3), headache (n = 1), hypertri-glyceridemia (n = 1), and allergic reaction (n = 1), which caused ESL discontinuation of ESL treatment. ESL is effective and well tolerated as monotherapy for patients with POS, which supports previous findings. Early use is supported by its frequent use as monotherapy in this study and lack of severe side effects. (C) 2017 Elsevier Inc. All rights reserved.
Filiaciones:
Toledano R:
Hospital Universitario Ramón y Cajal, Servicio de Neurología, Madrid, Spain
Hospital Ruber Internacional, Servicio de Neurología, Madrid, Spain
Jovel CE:
Hospital Occidente de Kennedy, Servicio de Neurología, Bogotá, Colombia
Jiménez-Huete A:
Hospital Ruber Internacional, Servicio de Neurología, Madrid, Spain
:
Hospital Universitario Doctor Peset, Servicio de Neurología, Valencia, Spain
Campos D:
Hospital Clínico Universitario de Valladolid, Servicio de Neurología, Valladolid, Spain
:
Hospital Público Lluis Alcanyís De Xátiva, Servicio de Neurología, Valencia, Spain
Giráldez BG:
Hospital Universitario Fundación Jiménez Díaz, Servicio de Neurología, Madrid, Spain
García-Morales I:
Hospital Universitario Clínico San Carlos, Servicio de Neurología, Madrid, Spain
Falip M:
Hospital Universitario de Bellvitge, Servicio de Neurología, Barcelona, Spain
Agredano PM:
Hospital Universitario Virgen del Rocío, Servicio de Neurología, Sevilla, Spain
Palao S:
Hospital General Universitario de Alicante, Servicio de Neurología, Alicante, Spain
Prior MJAA:
Hospital Universitario La Paz, Servicio de Neurología, Madrid, Spain
Pascual MRQ:
Complejo Universitario Hospital Infanta Cristina, Servicio de Neurología, Badajoz, Spain
Navacerrada FJ:
Hospital Universitario del Sureste, Servicio de Neurología, Madrid, Spain
González FJL:
Hospital Universitario de Santiago de Compostela, Servicio de Neurología, Santiago de Compostela, Spain
Ojeda J:
Hospital Universitario Infanta Sofía, Servicio de Neurología, Madrid, Spain
:
CIBER-BBN, Madrid, Spain
Hospital Vega Baja de Orihuela, Sección de Neurología, Alicante, Spain
Bermejo PE:
Hospital Universitario Puerta de Hierro, Servicio de Neurología, Madrid, Spain
Gil-Nagel A:
Hospital Universitario Ramón y Cajal, Servicio de Neurología, Madrid, Spain.
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