Long-term use of oxcarbazepine oral suspension in childhood epilepsy: open-label study.

Studies designed specifically for the pediatric population are needed to assess the tolerability and safety of the new antiepileptic drugs. The purpose of this study was to document the safety, ease of dosing, and acceptance of oxcarbazepine oral suspension in pediatric patients in monotherapy and polytherapy. A prospective, multicenter, open-label study was conducted at the neurology services of three pediatric university hospitals over 12 months. After obtaining signed informed consent, we enrolled a series of 62 patients with epilepsy aged between 2 months and 14 years who began oxcarbazepine treatment in monotherapy or in combination with other antiepileptic drugs to assess the seizure frequency, safety (adverse events), and acceptance of the pharmaceutical form by the patient's family. Fifty patients (80.6%) reduced seizures by at least 50%, 44 (71%) saw a reduction in seizure frequency of over 75%, and 29 (46.8%) were seizure free at the end of the study. The difference in the number of seizures before and after the study was statistically significant, both overall and by type of pathology. Adverse events occurred in four patients (6.4%) and required withdrawal of the drug in two cases (skin rash); three patients (4.8%) withdrew for inefficacy. Five patients (8.1%) withdrew from the treatment. We concluded that, in this series of patients, oxcarbazepine in oral suspension form was seen to help reduce seizure frequency, to have few side effects, and to be accepted by parents and patients.

[A critical analysis of the new classification of epilepsies and epileptic seizures of the International League Against Epilepsy (ILAE)]. / Analisis critico de la nueva clasificacion de las epilepsias y crisis epilepticas de la Liga Internacional contra la Epilepsia.

The classification of epilepsies and epileptic syndromes currently in use dates back to the eighties. Around thirty years later, it is now time to look for new approaches that are better adapted to the numerous advances that have taken place over the years in the different areas of research on epilepsy (genetics, neuroimaging, neurophysiology, etc.). In response to repeated calls by different authors to modify the classical approaches to epilepsy, in the year 2010 the Commission on Classification and Terminology of the International League Against Epilepsy (ILAE), led by Berg, published a terminological and conceptual revision of epileptic seizures and epilepsies with recommendations regarding the direction to be followed in their classification. This article, however, has received a great deal of criticism because it proposes a radical change with the elimination of classical concepts, without maintaining the useful elements and modifying only the parts that reflect obsolete concepts in the light of current scientific evidence. Unnecessary confusion has been generated by, for example, eliminating the division between focal and generalised epilepsies, but keeping the concept of focal and generalised epileptic seizures or by proposing a classification that mixes different approaches, electroclinical criteria, aetiology, and so on. Thus, the ILAE has before it the important task of striking a balance between the different opinions that have arisen and offering a new, more moderate proposal. At this point it would do well to recall the words of Seneca, who warned of the dangers of not proceeding in that way when he said: 'everything that exceeds the bounds of moderation has an unstable foundation'.

[Cases of video electroencephalogram: differential diagnosis in newborn infants]. / Casos de videoelectroencefalograma: diagnostico diferencial en el recien nacido.

This study addresses a number of general considerations on epilepsies and epileptic syndromes that develop in the neonatal period. The chronological limits of this stage of maturation are set out and the pathophysiology of the convulsive phenomenon during that period are briefly analysed. Furthermore, the differences that exist as a result of the incipient level of maturity of the newborn infant's central nervous system with regard to other ages, and obviously adults, are highlighted. Likewise, reference is made to the percentage values of this pathology, which even vary depending on the gestational age. The clinical expression has a personality that is very different from the other stages of maturation in children, with four predominant manifestations: subtle, tonic, clonic and myoclonic seizures, which have been universally accepted since they were first reported by Volpe. Epilepsies in the newborn infant are not sufficiently well differentiated in the different classifications of epilepsies and epileptic syndromes that have appeared in recent years, although they could well be, since they display enough significance and individuality for that to be so. Three clinical cases are reported, with the aid of video electroencephalographic findings, to illustrate some of the possible neonatal epileptic manifestations.

Efficacy and tolerability of lacosamide in the concomitant treatment of 130 patients under 16 years of age with refractory epilepsy: a prospective, open-label, observational, multicenter study in Spain.

BACKGROUND: The safety and effectiveness of lacosamide, an antiepileptic drug (AED) that selectively enhances the slow inactivation of voltage-gated sodium channels without affecting rapid inactivation, has been demonstrated in randomized, double-blind, placebo-controlled trials in adults with focal epileptic seizures. Although lacosamide is approved for use in patients over 16 years of age, limited clinical experience exists for younger patients. OBJECTIVE: To assess the efficacy and tolerability of lacosamide in children with refractory epilepsy. DesignMethods: The trial was a prospective, open-label, observational, multicenter study. A total of 130 patients aged less than 16 years (range 6 months to 16 years) with refractory epilepsy who had initiated treatment with lacosamide were enrolled at 18 neuropediatric units in hospitals across Spain. Patients with a variety of etiologies were enrolled, including those with partial epilepsies and symptomatic, generalized epilepsy syndromes. Lacosamide (VIMPAT®; UCB Pharma SA, Brussels, Belgium) was primarily administered once every 12 hours as an oral solution or as an oral tablet, with an initial dose of 1-2 mg/kg/day in the majority of cases. The majority of patients were also receiving stable concomitant therapy with ≥1 other AED. Treatment response to lacosamide was determined by assessing the change in seizure frequency after 3 months of lacosamide therapy. Responders were defined as patients who achieved a seizure frequency reduction of >50%. Tolerability was assessed by the reporting of adverse effects, laboratory testing, and electroencephalography recordings. RESULTS: Lacosamide was dosed at a mean of 6.80 ± 2.39 mg/kg/day. After 3 months of lacosamide therapy, 62.3% of patients achieved a >50% reduction in seizure frequency, with complete seizure suppression being reported in 13.8% of patients. Adverse effects occurred in 39 patients (30%), but no dose-response relationship was observed in terms of these events. In ten patients, instability, difficulty walking, an inability to relate to subjective elements, and blurred vision or dizziness were reported. A total of 13 patients discontinued treatment - in five of these patients, symptom intensity remained unchanged despite dose reduction, which led to treatment discontinuation. The symptoms were markedly different in each patient, preventing determination of a causal factor(s). CONCLUSIONS: The results of this study provide preliminary evidence for the efficacy of lacosamide in children with refractory epilepsy. Further evaluation in a randomized, controlled trial is needed to validate the efficacy in this population and to fully investigate the adverse effects described here. We recommend an initial dose of 1-2 mg/kg/day, uptitrated to 6-9 mg/kg/day over 4-6 weeks.

[Lennox-Gastaut syndrome in Spain: a descriptive retrospective epidemiological study]. / Síndrome de Lennox-Gastaut en España: estudio epidemiológico retrospectivo y descriptivo.

INTRODUCTION: Lennox-Gastaut syndrome (LGS) is one of the most severe epileptic syndromes in childhood. It is characterised by the presence of several types of seizures, a characteristic electroencephalographic trace and its frequent association with mental retardation. There are no accurate data on the epidemiology of LGS in Spain. AIM: To describe the epidemiological profile of LGS in Spain. PATIENTS AND METHODS: We conducted a retrospective epidemiological study of a series of 331 patients with LGS from 50 Spanish hospitals. Patients were considered to be cases of LGS if they had at least two of the three types of seizures that characterise LGS (axial tonic seizures, atypical absences and atonic seizures) and displayed slow diffuse intercritical spike-wave activity (lower than 3 Hz) in the electroencephalogram in wakefulness. RESULTS: The mean age of the patients was 18.2 +/- 13.5 years. Of the total sample, 62% were males and 97% had cognitive retardation. And 54% of cases had a symptomatic aetiology. The most frequent types of seizures were axial tonic (89%), followed by the atypical absent type (84%) and atonic seizures (69%). In all, 99% of patients were treated with polytherapy, the most commonly used drugs being valproic acid, lamotrigine and topiramate. CONCLUSIONS: The results of the study are in line with those from previous analyses carried out in populations with similar characteristics. The high percentage of LGS patients with cognitive retardation in this epileptic encephalopathy results in important family and social repercussions.