Neuro-Consil GmbH, Düsseldorf, Germany.
Clin Drug Investig. 2011 Nov 1;31(11):779-90. doi: 10.2165/11593850-000000000-00000.
Most patients with epilepsy require long-term medical therapy. Newer antiepileptic drugs (AEDs) appear to be overall similarly effective to older agents but may be better tolerated. However, most of the clinical data available for newer AEDs derive from a number of short-term studies. The objective of this study was to explore long-term outcomes in patients with epilepsy treated with topiramate in routine clinical practice.
This was an open-label, multicentre, optional follow-up monotherapy study that included adolescents and adults with epilepsy who completed two similarly designed 28- or 30-week studies and agreed to participate for an additional 52 weeks. Seizure types and frequency, topiramate dose, vital signs and treatment-emergent adverse events (TEAEs) after 12, 26, 39 and 52 weeks were documented. Post hoc analyses to explore differences between males and females were conducted.
114 patients (49.0% women, mean ± SD age 43 ± 17.5 years) with a mean ± SD disease duration of 61 ± 118 months (men 54 ± 96 vs women 68 ± 138 months) were followed up for a median of 18.5 months. Seventy-eight percent of patients completed the study. Reasons for premature discontinuation were: loss to follow-up (10.5%), TEAE (5.3%), lack of efficacy (2.6%), non-adherence (0.9%) and other reasons (4.4%). Seizure frequency per 4 weeks decreased from a mean ± SD 5.0 ± 28.3 at baseline to 0.6 ± 2.1 during the whole observation period. Fifty-four patients (52.9%) were seizure free during the whole observation period. In addition, 69 of 95 patients (72.6%) whose topiramate therapy was stable within a range of ±50 mg/day for a period of at least 12 months (maintenance phase) were seizure free while treated with a median topiramate dose of 100 mg/day. The most frequently reported TEAEs were paraesthesias (13.2% of patients), dizziness (7.0%) and seizure-related events (7.0%). No significant differences between males and females were found for treatment response or retention.
Topiramate is an effective and well tolerated long-term treatment option for adolescents and adults with epilepsy.
大多数癫痫患者需要长期的药物治疗。新型抗癫痫药物（AEDs）似乎在总体上与旧药同样有效，但可能具有更好的耐受性。然而，大多数新型 AED 的临床数据来自于一些短期研究。本研究的目的是探讨在常规临床实践中接受托吡酯治疗的癫痫患者的长期结局。
这是一项开放标签、多中心、可选的单药治疗随访研究，纳入了完成了两项相似设计的 28 或 30 周研究并同意再接受 52 周治疗的青少年和成年癫痫患者。记录了癫痫发作类型和频率、托吡酯剂量、生命体征和治疗后出现的不良事件（TEAEs）在 12、26、39 和 52 周时的情况。进行了事后分析以探索男女之间的差异。
114 例患者（49.0%女性，平均年龄 43 ± 17.5 岁），平均病程为 61 ± 118 个月（男性为 54 ± 96 个月，女性为 68 ± 138 个月），中位随访时间为 18.5 个月。78%的患者完成了研究。提前停药的原因包括：失访（10.5%）、TEAE（5.3%）、疗效不佳（2.6%）、不遵医嘱（0.9%）和其他原因（4.4%）。每 4 周的癫痫发作频率从基线时的平均 ±28.3 降至整个观察期间的 0.6 ±2.1。整个观察期间有 54 例（52.9%）患者无癫痫发作。此外，在至少 12 个月内托吡酯剂量稳定在 ±50 mg/天范围内的 95 例患者中，有 69 例（72.6%）无癫痫发作，中位托吡酯剂量为 100 mg/天。最常报告的 TEAEs 为感觉异常（13.2%的患者）、头晕（7.0%）和与癫痫发作相关的事件（7.0%）。在治疗反应或保留方面，男女之间没有发现显著差异。
托吡酯是一种有效且耐受性良好的青少年和成年癫痫患者的长期治疗选择。
