ObjectivesTo evaluate the efficacy and safety of lacosamide (200mg/d and 400mg/d)when added to 1 to 3 antiepileptic drugs (AEDs) in adults with uncontrolled partial-onset seizures. MethodsDuring this multicenter, double-blind, placebo-controlled trial, patients were randomized to placebo or lacosamide 200 or 400mg/day after an 8-week baseline period. Lacosamide was titrated in weekly increments to target dose over 4 weeks and maintained for 12 weeks followed by 12 weeks for withdrawal. The reductions of seizure frequence during maintain period and proportion of ≥50% reduction of seizures frequence were analysed. Besides,adverse effects were also recorded. ResultsFive hundred fourty patients were randomized, 515 patients completed the trial (Full analysis set, FAS), including 394 were per-protocol set (PPS). The reduction of seizure frequence during maintain period every 4 weeks among 200mg/d,400mg/d group and placebo group were 26.35%,40.12%,21.69%(P=0.000 5) and 25.61%,46.86%,23.06%(P<0.000 1), respectively in FAS and PPS. The proportion of ≥50% reduction of seizures frequence among three groups were 29.82%,38.15%,22.49%(P=0.006 8) and 27.94%,42.37%,22.86%(P=0.002 3), respectively in FAS and PPS. The incidences of adverse events were 5.84%, 36.11%, 19.55% among three groups. Compared with each other, there was statistic significance between 400mg/d and placebo groups. ConclusionIn this trial, adjunctive lacosamide significantly reduced seizure frequency in patients with uncontrolled partial-onset seizures. Along with favorable pharmacokinetic and tolerability profiles, these results support further development of lacosamide as an AED.
ObjectiveTo observe the clinical efficacy and safety of Lacosamide (LCM) monotherapy in treating Benign epilepsy with centro-temporal spikes (BECT) at children. MethodsThe present research included 57 children with BECT who were treated with LCM monotherapy in the Children's Hospital Affiliated to Soochow University from June 2020 to June 2021. Among them, 26 were males and 31 were females, with an average age of (7.5±2.3) years. Analyze the efficacy and adverse reactions of 1, 2, 4, 6, 9 and 12 months after LCM treatment. The starting dose of LCM was 2 mg/(kg·d); increased 2 mg/(kg·d) every seven days; and titrated up to 4 ~ 8 mg/(kg·d) in children with weight ≥30 kg and <50 kg; titrated up to 6 ~ 12 mg/(kg·d) in children with weight ≥11 kg and <30 kg.ResultThe total effective rate was 94.12%; the cumulative control rate after 12-month medication was 86.27%; and the retention rate was 89.47%. Those all showed a higher rate. ConclusionLCM is significantly effective to BECT with less adverse reactions and more safety. It has high clinical application value.
ObjectiveTo observe the efficacy and safety of lacosamide (LCM) as a monotherapy or as an add-on in the treatment of focal epilepsy in children aged 4 months to 4 years. MethodsThe study included 20 children with focal epilepsy who received oral LCM monotherapy or add-on therapy in Children's Hospital Affiliated to Soochow University from March 2022 to September 2022, including 9 males and 11 females with an average age of (22.4±13.0) months. The curative effects and adverse reactions at 1, 2, 3, 4, and 6 months after LCM treatment were analyzed. The initial dose of LCM was 2 mg/(kg·d) and increased by 2 mg/(kg·d) every week, maintenance dose 6 ~ 12mg/(kg·d). Results During the follow-up period of this study, the total effective cases were 17 (85.00%), and the number of control-free cases was 15 (75.00%). Conclusion LCM can effectively reduce the frequency of epileptic seizures in the monotherapy or add-on treatment of infants and young children with focal epilepsy, with few adverse reactions and high retention rate, which has high clinical application value.
Epilepsy (EP) is one of the most common chronic nervous system disease in childhood and adolescence, with a prevalence rate of 7.6‰. About 3/4 of epilepsy patients begin to get sick in childhood. At present, there are many ways to treat epilepsy, such as oral anti-seizure medications (ASMs), surgical treatment, ketogenic diet, etc. However, ASMs are the preferred treatment for most epilepsy patients and the most important and basic treatment. Oxcarbazepine (OXC) and Lacosamide (LCM) are both sodium channel blockers. The former is a second-generation ASMs, a fast sodium channel blocker, while the latter is a third-generation ASMs, a slow sodium channel blocker. The rapid inactivation of sodium channel is mediated by the inner pore ball chain mechanism in milliseconds, which is helpful to the termination of action potential and the regulation of refractory period. It is the main inactivation mode under normal physiological conditions. Different from the rapid inactivation of sodium channels, the slow inactivation is in seconds per minute, which may involve the rearrangement of the inner pore structure and increase the excitability of the action potential threshold regulating membrane. Generally, under pathological conditions, sodium channels are more likely to enter the slow inactivation state. Now, OXC and LCM have been approved by the US Food and Drug Administration, the European Union Drug Administration, and the National Drug Administration of China for monotherapy or additive therapy of focal origin (with or without secondary generalized seizures) in epilepsy patients aged 4 years and above. This article will focus on the pharmacokinetics, efficacy, and safety of LCM and OXC in the treatment of childhood epilepsy.