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 LCM was withdrawn in 2 patients due to intolerance and in 1 patient because of inefficacy.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.

[Assessment of the effectiveness and safety of Sativex® in compassionate use]. / Evaluación de eficacia y tolerabilidad de Sativex® en uso compasivo.

INTRODUCTION: Sativex® is a drug approved for use in the treatment of spasticity in multiple sclerosis. We sought to study the tolerability and effectiveness of this drug product in pathologies beyond the scope of the indications of the product data sheet, by means of its compassionate use. AIM: To evaluate the effectiveness and safety of Sativex in pathologies that are not included on the product data sheet, using a compassionate use protocol. PATIENTS AND METHODS: A six-month observational study was conducted to evaluate the effectiveness and safety of Sativex in neuropathic pain and in spasticity from causes other than multiple sclerosis. RESULTS: A total of 10 patients were included: six females and four males. Side effects appeared in only two of them and the drug product was withdrawn in one case. After starting treatment with Sativex by means of a compassionate use protocol, the consumption of concomitant drugs was reduced by 34.2% (p=0.004), and administration of botulinum toxin was suspended in seven patients (70%). The improvement on the Ashworth spasticity scale was 65.6% (p=0.004) and the score on the analogical visual scale dropped by 49.2% (p=0.026). CONCLUSIONS: Sativex may be an interesting therapeutic alternative in patients with spasticity and pain when the treatments that are usually available have been employed but patients' quality of life continues to be significantly compromised.

TITLE: Evaluacion de eficacia y tolerabilidad de Sativex ® en uso compasivo.Introduccion. Sativex ® es un farmaco aprobado para el tratamiento de la espasticidad en la esclerosis multiple. Hemos querido estudiar la tolerabilidad y eficacia de este farmaco en patologias fuera de indicacion de ficha tecnica, mediante su uso compasivo. Objetivo. Valorar la eficacia y tolerabilidad de Sativex en patologias no incluidas en la ficha tecnica, mediante un protocolo de uso compasivo. Pacientes y metodos. Se realizo un estudio observacional, de seis meses de duracion, para evaluar la eficacia y tolerabilidad de Sativex en el dolor neuropatico y en la espasticidad de causa diferente a la esclerosis multiple. Resultados. Se incluyo un total de 10 pacientes, seis mujeres y cuatro hombres. Solo hubo efectos adversos en dos de ellos, y el farmaco se suspendio en un caso. Tras el inicio del tratamiento con Sativex mediante protocolo de uso compasivo, el consumo de farmacos concomitantes se redujo un 34,2% (p = 0,004), y se suspendio la administracion de toxina botulinica en siete pacientes (70%). La mejoria de la escala de espasticidad de Ashworth fue del 65,6% (p = 0,004) y la escala visual analogica disminuyo su puntuacion un 49,2% (p = 0,026). Conclusion. Sativex puede ser una alternativa terapeutica interesante en pacientes con espasticidad y dolor cuando se han utilizado los tratamientos habituales disponibles, pero los pacientes continuan con afectacion significativa de su calidad de vida.

[Tropical spastic paraparesis: a report of a new case in Spain]. / Paraparesia espastica tropical: presentacion de un nuevo caso en España.

TITLE: Paraparesia espastica tropical: presentacion de un nuevo caso en España.

[Leber's optic neuropathy, ten years on: Harding's syndrome]. / Neuropatía óptica de Leber, diez años después: síndrome de Harding.

TITLE: Neuropatia optica de Leber, diez años despues: sindrome de Harding.

[Zonisamide in the preventive treatment of refractory migraine]. / Zonisamida en el tratamiento preventivo de la migraña refractaria.

INTRODUCTION: Chronic migraine refractory to preventive treatment is a common clinical situation in general neurology clinics. The aim is to analyse our experience with zonisamide in the preventive treatment of patients with frequent refractory migraine. PATIENTS AND METHODS: Those patients with no response or intolerance to topiramate and at least one more preventative received zonisamide. This drug was increased 25 mg per week up to 200 mg/day. The efficacy of zonisamide was evaluated in terms of 'response' (reduction in attack frequency below 50%) at the third month of treatment. RESULTS: Our series comprises a total of 172 patients, with ages ranging from 22 to 69 years. 85% were women. The final dosage of zonisamide was 50-200 mg/day, with the 100 mg/day being the most frequently administered dose. Zonisamide was efficacious (response) in 76 (44%) patients; response being excellent in 22 (13%). MIDAS score was reduced by 43.2%. Zonisamide was not tolerated by 27% of the patients, mainly due to subjective mental slowness or digestive symptoms. CONCLUSIONS: These results, obtained in a big sample of patients refractory or intolerant to topiramate and other preventatives, indicate that, at least in conditions of daily clinical practice, zonisamide, at relatively low dosages, is an option to be considered for the preventive treatment of patients with frequent migraine.