LACONORTE study: Efficacy and security of lacosamide as first add-on therapy for focal-onset epilepsy in real-life setting.

RATIONALE: Many patients with epilepsy need a second antiepileptic drug (AED), due either to inefficacy or side effects of the first tried one. We evaluated the efficacy and safety of lacosamide (LCM) as first add-on therapy in the real-life setting. METHODS: LACONORTE is a multicenter, retrospective, one-year study. Patients with focal epilepsy on monotherapy with another AED who were started on lacosamide as first add-on therapy were included. Clinical data was obtained at 3, 6 and 12 months and then analyzed. RESULTS: Seventy-three patients (48.6% men) with a mean age of 50.3 and a median duration of the epilepsy of 3.0 years (range 0-65) were included. At 1 year, 91.8% were responders (with at least 50% reduction in the number of seizures) and 64.4% of all patients and 75.8% of those with secondary generalization were seizure-free. Fifteen patients (20.5%) had adverse events (AE), most of them were transient and no severe AEs were reported. LCM was withdrawn in 2 patients due to intolerance and in 1 patient because of inefficacy. Neither side effects nor withdrawal seemed to be related to total dose or to escalating regimes. Seventy patients (95.9%) continued on LCM after the last visit (median dose 200 mg/day, ranging 100-400). Eighteen (24.7%) converted to monotherapy during the 12-month period, 83.3% of them remaining seizure-free. CONCLUSIONS: These results of real-life setting show LCM to be efficacious and safe when used as first add-on therapy for focal-onset epilepsy. Most adverse events were mild and/or transient.

[Clinical experience with lacosamide in Galicia: the GALACO study]. / Experiencia clinica con lacosamida en Galicia: estudio GALACO.

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.

[Pain in Parkinson's disease: prevalence, characteristics, associated factors, and relation with other non motor symptoms, quality of life, autonomy, and caregiver burden]. / Dolor en la enfermedad de Parkinson: prevalencia, características, factores asociados y relación con otros síntomas no motores, calidad de vida, autonomía y sobrecarga del cuidador.

INTRODUCTION: Pain is one of the most common non motor symptoms in patients with Parkinson's disease (PD). However, it is underrecognized. We examine the prevalence of pain, characteristics, associated factors, and relation with quality of life and autonomy in a consecutive series of PD patients. PATIENTS AND METHODS: Pain was identified according to International Association for the Study of Pain. Brief Pain Inventory and Medical Outcomes Study 36-Item Short Form were used. RESULTS: Of the 159 patients (72.31 ± 8.83 years; 51.3% female), 115 (72.3%) presented pain. Of these, 51.3% reported pain onset before PD-diagnosis, 27.8% two or more pain types, and 53% PD-related pain. Musculoskeletal (74.8%) and radicular-neuropathic (24.3%) were the types of pain most frequent. The 37.4% of the patients with pain did not received analgesic treatment. Depression was an independent predictor of pain (OR = 7.82; 95% CI = 1.151-53.183; p = 0.035). Pain was an independent predictor of worst quality of life (PDQ-39; regression coefficient: 25.53; standard error: 11.852; 95% CI = 1.48-49.57; p = 0.03) and lower autonomy (Schwab and England; regression coefficient: -13.85; standard error: 6.327; 95% CI = -26.58 to -1.2; p = 0.034). CONCLUSIONS: Pain is very frequent in PD patients. It is associated with depression, and predicts a worst quality of life and lower autonomy for the patient.

Management of Patients With Unclassified Epileptic Seizures in Outpatient Clinics in Spain. Results of the RETO Study.

PURPOSE: The objective of this study was to determine the approach and management of specialists in patients with unclassified epileptic seizures in outpatient clinics in Spain. METHODS: Observational, multicenter, and cross-sectional study. Ninety-three neurologists or neuropediatricians documented consecutive patients with a history of at least two difficult to classify or unclassified epileptic seizures. Patient demographics, quality of life (QOLIE-10-P), disease characteristics, and anticonvulsant treatment were captured. Physicians were asked about their therapeutic approach for the selection of an antiepileptic drug and underlying reasons. RESULTS: A total of 725 patients were included. At the time of the survey, 81% were treated (69% with monotherapy). Most frequently given reasons for starting antiepileptic therapy were ([mean] on a scale of 1­5) efficacy, (3.9), safety (3.61), and broad-spectrum effectiveness (3.5). Reasons given for switching therapy (226/725) included need for broader spectrum of action: 70 (31.0%); simpler dosing regimen: 25 (11.1%); quality of life considerations: 24 (10.6%); lack of adherence to therapy: 24 (10.6%); comorbidities: 13 (5.8%); drug interactions: 12 (5.3%); and possibility of pregnancy 6 (2.7%). CONCLUSIONS: When deciding on starting or switching therapy for patients with difficult to classify or unclassified epilepsy, the most important consideration for the specialists included efficacy, safety, and broad-spectrum efficacy.