Rufinamide for the adjunctive treatment of partial seizures in adults and adolescents: A randomized placebo-controlled trial
Rufinamide for the adjunctive treatment of partial seizures in adults and adolescents: A randomized placebo-controlled trial
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DOI：
10.1111/j.1528-1167.2009.02160.x
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发表时间：
2009-08-01
期刊：
影响因子：
5.6
通讯作者：
Arroyo, Santiago
中科院分区：
文献类型：
--
作者：
Brodie, Martin J.;Rosenfeld, William E.;Arroyo, Santiago
目的：评价鲁非那胺1600 mg每日2次辅助治疗bb0 = 16岁难治性部分性癫痫的疗效和安全性。方法：该双盲、安慰剂对照、随机、平行组、多中心试验包括8周基线期和13周双盲期。治疗开始时使用rufinamide 400 mg，每日2次或安慰剂；鲁非那胺滴定至1600毫克，每日两次。部分发作频率的百分比变化是主要的结局指标。次要结局指标包括总部分发作频率和部分发作频率减少50%的受试者百分比。结果：共纳入313名受试者；156名受试者接受鲁非胺治疗，157名受试者接受安慰剂治疗。鲁非那胺治疗的受试者相对于基线，部分癫痫发作频率中位数降低20.4%，而安慰剂治疗的受试者增加1.6% （p = 0.02）。在事后分析中，排除服用卡马西平的受试者减少了29.2%，而安慰剂组减少了0.7% (p = 0.05)，而服用卡马西平的受试者的治疗差异并不显著。在鲁非那胺治疗的受试者中，28.2%的受试者部分癫痫发作频率下降了50%，而安慰剂治疗的受试者为18.6% （p = 0.04）。与鲁非胺治疗相关的最常见不良事件是头晕、恶心、复视和共济失调；它们主要发生在滴定阶段。讨论：与对照安慰剂相比，鲁非那胺3200mg /天的辅助治疗显示出对部分性癫痫发作的成年人有效，并且通常耐受性良好。在服用一系列基线aed的部分癫痫发作的成人中进一步研究该药物是有必要的。
Purpose:To evaluate efficacy and safety of adjunctive treatment with rufinamide 1600 mg twice daily in subjects aged >= 16 years with refractory partial seizures.Methods:This double-blind, placebo-controlled, randomized, parallel-group, multicenter trial included an 8-week baseline phase and a 13-week double-blind phase. Treatment was initiated with rufinamide 400 mg twice daily or placebo; rufinamide was titrated to 1600 mg twice daily. Percentage change in partial seizure frequency was the primary outcome measure. Secondary outcome measures included total partial seizure frequency and the percentage of subjects experiencing a >= 50% reduction in partial seizure frequency.Results:Three hundred thirteen subjects were randomized; 156 subjects received rufinamide and 157 received placebo. Rufinamide-treated subjects experienced a 20.4% median reduction in partial seizure frequency relative to baseline, while placebo-treated subjects had an increase of 1.6% (p = 0.02). Exclusion of subjects taking carbamazepine in a post hoc analysis resulted in a reduction of 29.2% versus 0.7% in the placebo group (p = 0.05), whereas the treatment difference in subjects taking carbamazepine was not significant. Of rufinamide-treated subjects, 28.2% experienced a >= 50% decrease in partial seizure frequency versus 18.6% of placebo-treated subjects (p = 0.04). The most common adverse events associated with rufinamide treatment were dizziness, nausea, diplopia, and ataxia; they occurred primarily during the titration phase.Discussion:Adjunctive therapy with rufinamide 3200 mg/day compared with matching placebo demonstrated efficacy and was generally well tolerated in adults with partial seizures. Further study of this agent in adults with partial seizures taking a range of baseline AEDs is warranted.