Topiramate for migraine prevention - A randomized controlled trial
Topiramate for migraine prevention - A randomized controlled trial
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DOI：
10.1001/jama.291.8.965
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发表时间：
2004-02-25
影响因子：
120.7
通讯作者：
Jacobs, D
中科院分区：
文献类型：
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作者：
Brandes, JL;Saper, JR;Jacobs, D
背景小的开放标签和对照试验表明，抗癫痫药物托吡酯是有效的偏头痛prevention. ObjectiveTo评估的有效性和安全性托吡酯预防偏头痛在一个大型的对照trial.Design，设置，和Patients一个26周，随机，双盲，安慰剂对照研究期间门诊治疗在52个北美临床中心进行。患者年龄为12至65岁，有6个月的偏头痛史（国际头痛协会标准）和3至12个偏头痛一个月，但不超过15个头痛天一个月在28天的前瞻性基线phase.Interventions洗脱期后，符合入选标准的患者被随机分配到托吡酯（50，100，或200毫克/天）或安慰剂。托吡酯滴定25 mg/wk为8周的指定或最大耐受剂量，以较小者为准。患者继续接受该剂量为18 weeks.Main Outcome Measures主要疗效指标是平均每月偏头痛频率从基线的变化。次要疗效指标包括应答率（每月偏头痛频率降低≥ 50%的患者比例）、每月偏头痛平均天数的减少、严重程度、持续时间和每月需要补救药物的天数以及不良事件。在483例随机分组的患者中，468例提供了至少1次基线后疗效评估，并构成了意向治疗人群。接受托吡酯100 mg/d和200 mg/d治疗的患者平均每月偏头痛频率显著降低（-2.1，P=.008）（-2.4，P
Context Small open-label and controlled trials suggest that the antiepileptic drug topiramate is effective for migraine prevention.Objective To assess the efficacy and safety of topiramate for migraine prevention in a large controlled trial.Design, Setting, and Patients A 26-week, randomized, double-blind, placebo-controlled study was conducted during outpatient treatment at 52 North American clinical centers. Patients were aged 12 to 65 years and had a 6-month history of migraine (International Headache Society criteria) and 3 to 12 migraines a month but no more than 15 headache days a month during a 28-day prospective baseline phase.Interventions After a washout period, patients meeting entry criteria were randomized to topiramate (50, 100, or 200 mg/d) or placebo. Topiramate was titrated by 25 mg/wk for 8 weeks to the assigned or maximum tolerated dose, whichever was less. Patients continued receiving that dose for 18 weeks.Main Outcome Measures The primary efficacy measure was change from baseline in mean monthly migraine frequency. Secondary efficacy measures included responder rate (proportion of patients with greater than or equal to50% reduction in monthly migraine frequency), reductions in mean number of monthly migraine days, severity, duration, and days a month requiring rescue medication, and adverse events. The month of onset of preventive treatment action was assessed.Results Of 483 patients randomized, 468 provided at least 1 postbaseline efficacy assessment and comprised the intent-to-treat population. Mean monthly migraine frequency decreased significantly for patients receiving topiramate at 100 mg/d (-2.1, P=.008) and topiramate at 200 mg/d (-2.4, P