Villanueva Vicente, Serrano-Castro Pedro J
Unidad Multidisciplinar de Epilepsia, Servicio de Neurología, Hospital Universitario y Politécnico La Fe, Valencia.
Rev Neurol. 2013 Apr 16;56(8):429-38.
Zonisamide is an antiepileptic drug firstly approved in Europe as add-on therapy in adult patients with partial seizures and recently as monotherapy.
To analyze the clinical development of zonisamide in Europe and USA.
It is a sulfonamide derivative that exerts its antiepileptic effect through different mechanisms, ion channels, neurotransmitters and free radicals. It has a lineal pharmacokinetic at usual doses, an hepatic metabolism without induction of other drugs and a half life of 60 hours. For his approval in USA and Europe four clinical randomized regulatory trials were performed. The efficacy of the drug was evaluated between 100 and 500 mg, showing a seizure reduction with respect to basal period between 24.7% (100 mg) and 52.5% (500 mg). The most frequent side effects were dizziness, fatigue, somnolence and weight loss. There is broad experience in conditions close to clinical practice in patients with partial epilepsy and different degree of refractoriness, pediatric population, monotherapy, generalized epilepsy and other special populations. Recently the results of a clinical trial in monotherapy have proved its efficacy in a no-inferiority design with carbamazepine. The seizure-free rate in the zonisamide group was 79.4%.
At this moment, zonisamide represents a robust option in the treatment of a large number of patients with epilepsy, based on its multiple mechanism of action and efficacy in different situations.
唑尼沙胺是一种抗癫痫药物，最初在欧洲被批准作为成人部分性癫痫患者的辅助治疗药物，最近也被批准用于单药治疗。
分析唑尼沙胺在欧洲和美国的临床研发情况。
它是一种磺胺类衍生物，通过不同机制（离子通道、神经递质和自由基）发挥抗癫痫作用。在常用剂量下具有线性药代动力学，经肝脏代谢且不诱导其他药物代谢，半衰期为60小时。为了在美国和欧洲获批，进行了四项临床随机对照试验。评估了该药物100至500毫克剂量的疗效，与基线期相比癫痫发作减少率在24.7%（100毫克）至52.5%（500毫克）之间。最常见的副作用是头晕、疲劳、嗜睡和体重减轻。在部分癫痫患者以及不同难治程度的患者、儿科人群、单药治疗、全身性癫痫和其他特殊人群中，有接近临床实践情况的广泛经验。最近一项单药治疗临床试验的结果在与卡马西平的非劣效性设计中证明了其疗效。唑尼沙胺组的无癫痫发作率为79.4%。
目前，基于其多种作用机制以及在不同情况下的疗效，唑尼沙胺是治疗大量癫痫患者的有力选择。
