ABSTRACT
AIM: The aim of the study was to evaluate the effectiveness and tolerability of eslicarbazepine acetate (ESL) when used as monotherapy for 1â¯year or more in routine clinical use in patients with focal seizures in epilepsy clinics in Spain. METHODS: This is a retrospective, observational, noninterventional study. Eligible patients were aged ≥18â¯years, had focal seizures, and started on ESL ≥1â¯year before database closure. Primary endpoint was the following: proportion seizure-free for ≥6â¯months at 1 and 2â¯years. Secondary endpoints included retention on ESL monotherapy at 1 and 2â¯years, seizure frequency change, seizure worsening, and side effects. Other analyses included seizure freedom from baseline to 1 and 2â¯years and outcomes in special populations. RESULTS: Four hundred thirty-five patients were included (127 on first-line monotherapy and 308 converting to ESL monotherapy): median daily dose was 800â¯mg at all time points; 63.2% were seizure-free at 1â¯year, 65.1% at 2â¯years, and 50.3% for the entire follow-up. Mean duration of ESL monotherapy was 66.7â¯months; retention was 88.0% at 1â¯year and 81.9% at 2â¯years. Mean reduction in seizure frequency was 75.5% at last visit. Over the entire follow-up, seizure worsening was seen in 22 patients (5.1%), side effects in 28.0%, considered severe in 1.8%, and leading to discontinuation in 5.7%. Dizziness, hyponatremia (sodium <135â¯mEq/l), and somnolence were the most frequent side effects. Outcomes in special populations (patients aged ≥65â¯years and those with psychiatric history or learning difficulty) were consistent with the overall population. CONCLUSIONS: Patients with focal seizures taking ESL monotherapy had excellent retention, high seizure-free rates, and good tolerability up to 2â¯years.
Subject(s)
Anticonvulsants/therapeutic use , Dibenzazepines/therapeutic use , Epilepsy/drug therapy , Seizures/drug therapy , Adolescent , Adult , Aged , Aged, 80 and over , Anticonvulsants/adverse effects , Dibenzazepines/adverse effects , Dizziness/chemically induced , Female , Humans , Hyponatremia/chemically induced , Longitudinal Studies , Male , Middle Aged , Retrospective Studies , Sleepiness , Young AdultABSTRACT
INTRODUCTION: Lacosamide is a sodium channel blocker antiepileptic drug authorized as an adjunctive therapy for focal seizures in adolescents and adults. AIM: To analyze the efficacy and safety of lacosamide in Galicia according to its use in daily clinical practice. PATIENTS AND METHODS: Retrospective observational study in patients who started treatment with lacosamide between January 2014 and June 2013 in 10 hospitals in Galicia, Spain. Its efficacy and safety at 3, 6 and 12 months after starting lacosamide was assessed. RESULTS: We included 184 patients with a mean age of 44.2 ± 17.4 years old; 56.5% (n = 104) were male; 173 patients constituted the efficacy population. Mean duration of epilepsy was 18.8 ± 15.5 years. Seizure frequency was 2.5 ± 1.6 episodes/month. After 12 months, 68.2% of patients (n = 118) had >= 50% improvement (responders) and among them, 54 (45.8% of responder patients) were seizure free. Twenty-three percent (n = 43) suffered from adverse events after 12 months, being dizziness (10.3%) and instability (3.3%) the most frequently reported. After the 12 month visit, 87.5% of patients (n = 161) continued treatment with lacosamide. CONCLUSIONS: Lacosamide provides a very good efficacy and safety profile for patients with focal refractory epilepsy. High percentage of responders may be related to a less refractory population compared to other daily clinical practice studies. It constitutes an attractive therapeutic option for the treatment of focal epilepsies.
TITLE: Experiencia clinica con lacosamida en Galicia: estudio GALACO.Introducción. La lacosamida es un fármaco antiepiléptico bloqueante de los canales de sodio, autorizado en adolescentes y adultos como tratamiento coadyuvante en crisis de inicio focal. Objetivo. Analizar los resultados de eficacia y seguridad de la lacosamida en Galicia en su uso de acuerdo con la práctica clínica habitual. Pacientes y métodos. Estudio retrospectivo observacional en pacientes que iniciaron tratamiento con lacosamida entre enero de 2013 y junio de 2014 en 10 hospitales de Galicia. Se evaluó su eficacia y seguridad a los 3, 6 y 12 meses del inicio del tratamiento. Resultados. Se incluyeron 184 pacientes con edad media de 44,2 ± 17,4 años; el 56,5% (n = 104) eran varones. Conforman la población de eficacia 173 pacientes. El tiempo medio de evolución de la epilepsia fue de 18,8 ± 15,5 años. La frecuencia de crisis era de 2,5 ± 1,6 episodios/mes. A los 12 meses, el 68,2% de los pacientes (n = 118) presentaba una mejoría igual o superior al 50% (pacientes respondedores) y, de ellos, 54 (el 45,8% de los respondedores) estaban libres de crisis. El 23,4% (n = 43) refirió efectos adversos a los 12 meses, principalmente mareos (10,3%) e inestabilidad (3,3%). Después de la visita de los 12 meses, continuaba con lacosamida el 87,5% de los pacientes (n = 161). Conclusiones. La lacosamida ofrece un perfil de eficacia y seguridad muy favorable para pacientes con epilepsia focal refractaria. El elevado porcentaje de respondedores podría atribuirse a una población de epilépticos menos refractarios que en otros estudios de práctica clínica. Constituye una opción terapéutica atractiva para el tratamiento de epilepsias de inicio focal.
Subject(s)
Acetamides/therapeutic use , Anticonvulsants/therapeutic use , Epilepsy/drug therapy , Acetamides/adverse effects , Adult , Anticonvulsants/adverse effects , Drug Therapy, Combination , Female , Humans , Lacosamide , Male , Middle Aged , Nervous System Diseases/chemically induced , Retrospective Studies , Sodium Channel Blockers/adverse effects , Sodium Channel Blockers/therapeutic use , SpainABSTRACT
Introducción. La lacosamida es un fármaco antiepiléptico bloqueante de los canales de sodio, autorizado en adolescentes y adultos como tratamiento coadyuvante en crisis de inicio focal. Objetivo. Analizar los resultados de eficacia y seguridad de la lacosamida en Galicia en su uso de acuerdo con la práctica clínica habitual. Pacientes y métodos. Estudio retrospectivo observacional en pacientes que iniciaron tratamiento con lacosamida entre enero de 2013 y junio de 2014 en 10 hospitales de Galicia. Se evaluó su eficacia y seguridad a los 3, 6 y 12 meses del inicio del tratamiento. Resultados. Se incluyeron 184 pacientes con edad media de 44,2 ± 17,4 años; el 56,5% (n = 104) eran varones. Conforman la población de eficacia 173 pacientes. El tiempo medio de evolución de la epilepsia fue de 18,8 ± 15,5 años. La frecuencia de crisis era de 2,5 ± 1,6 episodios/mes. A los 12 meses, el 68,2% de los pacientes (n = 118) presentaba una mejoría igual o superior al 50% (pacientes respondedores) y, de ellos, 54 (el 45,8% de los respondedores) estaban libres de crisis. El 23,4% (n = 43) refirió efectos adversos a los 12 meses, principalmente mareos (10,3%) e inestabilidad (3,3%). Después de la visita de los 12 meses, continuaba con lacosamida el 87,5% de los pacientes (n = 161). Conclusiones. La lacosamida ofrece un perfil de eficacia y seguridad muy favorable para pacientes con epilepsia focal refractaria. El elevado porcentaje de respondedores podría atribuirse a una población de epilépticos menos refractarios que en otros estudios de práctica clínica. Constituye una opción terapéutica atractiva para el tratamiento de epilepsias de inicio focal (AU)
Introduction. Lacosamide is a sodium channel blocker antiepileptic drug authorized as an adjunctive therapy for focal seizures in adolescents and adults. Aim. To analyze the efficacy and safety of lacosamide in Galicia according to its use in daily clinical practice. Patients and methods. Retrospective observational study in patients who started treatment with lacosamide between January 2014 and June 2013 in 10 hospitals in Galicia, Spain. Its efficacy and safety at 3, 6 and 12 months after starting lacosamide was assessed. Results. We included 184 patients with a mean age of 44.2 ± 17.4 years old; 56.5% (n = 104) were male; 173 patients constituted the efficacy population. Mean duration of epilepsy was 18.8 ± 15.5 years. Seizure frequency was 2.5 ± 1.6 episodes/month. After 12 months, 68.2% of patients (n = 118) had ≥ 50% improvement (responders) and among them, 54 (45.8% of responder patients) were seizure free. Twenty-three percent (n = 43) suffered from adverse events after 12 months, being dizziness (10.3%) and instability (3.3%) the most frequently reported. After the 12 month visit, 87.5% of patients (n = 161) continued treatment with lacosamide. Conclusions. Lacosamide provides a very good efficacy and safety profile for patients with focal refractory epilepsy. High percentage of responders may be related to a less refractory population compared to other daily clinical practice studies. It constitutes an attractive therapeutic option for the treatment of focal epilepsies (AU)
