Kowalik A, Rimpau W, Adam H, Kühn F, van Oene J, Schreiner A, Bogdanow M, Schauble B
Section of Neurology, Bürgerspital Stuttgart, Stuttgart, Germany.
Acta Neurol Scand. 2008 Mar;117(3):159-66. doi: 10.1111/j.1600-0404.2007.00977.x. Epub 2008 Jan 23.
To explore effectiveness, tolerability and changes in quality of life in patients with epilepsy converting to topiramate (TPM) from carbamazepine (CBZ) or oxcarbazepine (OXC) due to insufficient effectiveness and/or tolerability.
A multicenter, open-label, non-interventional trial was used to examine patients (> or = 12 years) with epilepsy, changing to TPM monotherapy from baseline mono- or combination therapy with CBZ or OXC. TPM was added to the existing antiepileptic drug (AED) treatment and started at a dose of 25 mg once daily. The dose was titrated up with 25 mg/day increments, once every 1-2 weeks, until a final dose between 50 and 200 mg/day was reached. On the basis of clinical judgment, the treating physician decided whether or not the existing AED treatment with CBZ or OXC could then be withdrawn. Type and number of seizures, preferred TPM dose, quality of life (QOLIE-10 questionnaire), subjective perception of improvement and adverse events (AE) were documented.
140 patients (53.5% women, mean age 47 years) decided to switch to TPM due to insufficient effectiveness (75% of patients) and/or poor tolerability (80%) of the CBZ/OXC treatment. Average duration of follow-up was 24 weeks with an overall discontinuation rate of 19.3%, mainly due to AEs (12.1%). At study endpoint, the intended shift to TPM monotherapy was achieved in 73% of patients at a median TPM dose of 100 mg/day. A seizure reduction of > or = 50% was achieved in 91% of patients in the last scheduled period (weeks 12-26); 62% of patients entering that period remained seizure free. Quality of life at endpoint improved significantly when compared with baseline for all domains of QOLIE-10 (P < 0.001). Most frequent AEs (reported by > or = 5% of patients) were paresthesia (9.3%), weight loss (7.9%), convulsions (5.7%) and memory disorders (5.0%).
In patients with epilepsy, previously not satisfactorily treated with CBZ or OXC, conversion to TPM may result in an improvement in seizure control as well as in quality of life.
探讨因疗效不佳和/或耐受性差而从卡马西平（CBZ）或奥卡西平（OXC）转换为托吡酯（TPM）治疗的癫痫患者的有效性、耐受性及生活质量变化。
采用多中心、开放标签、非干预性试验，研究年龄≥12岁的癫痫患者，从基线时的CBZ或OXC单药或联合治疗转换为TPM单药治疗。TPM添加到现有的抗癫痫药物（AED）治疗中，起始剂量为每日25mg一次。剂量每1 - 2周以每日增加25mg的幅度滴定，直至达到每日50 - 200mg的最终剂量。根据临床判断，治疗医师决定是否停用现有的CBZ或OXC AED治疗。记录癫痫发作的类型和次数、TPM的最佳剂量、生活质量（QOLIE - 10问卷）、主观改善感受及不良事件（AE）。
140例患者（53.5%为女性，平均年龄47岁）因CBZ/OXC治疗效果不佳（75%的患者）和/或耐受性差（80%）决定转换为TPM治疗。平均随访时间为24周，总体停药率为19.3%，主要原因是不良事件（12.1%）。在研究终点，73%的患者实现了向TPM单药治疗的预期转换，TPM的中位剂量为每日100mg。在最后一个预定时间段（第12 - 26周），91%的患者癫痫发作减少≥50%；进入该时间段的患者中有62%无癫痫发作。与基线相比，终点时QOLIE - 10所有领域的生活质量均有显著改善（P < 0.001）。最常见的不良事件（≥5%的患者报告）为感觉异常（9.3%）、体重减轻（7.9%）、惊厥（5.7%）和记忆障碍（5.0%）。
对于先前使用CBZ或OXC治疗效果不佳的癫痫患者，转换为TPM治疗可能会改善癫痫控制及生活质量。
