Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA.
Headache. 2012 Jan;52(1):57-67. doi: 10.1111/j.1526-4610.2011.02027.x. Epub 2011 Nov 11.
To assess efficacy and tolerability of rizatriptan orally disintegrating tablet (ODT) for treatment of acute migraine in patients using topiramate for migraine prophylaxis.
There are limited data from prospective controlled trials demonstrating the benefit of triptans in patients who experience migraine attacks while taking prophylactic medication.
This was a worldwide, randomized, placebo-controlled, double-blind, multiple-attack study in adults with a >1-year history of migraine taking a stable dose of topiramate for migraine prophylaxis and experiencing ≥2 moderate/severe attacks per month. Participants treated 3 moderate/severe attacks in crossover fashion (2 with rizatriptan 10-mg ODT, 1 with placebo) following random assignment to 1 of 3 treatment sequences. The primary end point was 2-hour pain relief.
Two-hour pain relief was significantly greater with rizatriptan compared with placebo (55.0% vs 17.4%, P < .001). Response rates also favored rizatriptan for sustained pain relief from 2-24 hours (32.6% vs 11.1%, P < .001), 2-hour pain freedom (36.0% vs 6.5%, P < .001), normal functional ability at 2 hours (42.2% vs 12.7%, P < .001), and overall treatment satisfaction at 24 hours (60.8% vs 33.6%, P < .001). Few participants reported adverse experiences (16 [15.8%] with rizatriptan, 3 [3.2%] with placebo); none were serious.
Rizatriptan 10-mg ODT was superior to placebo at all pain end points for treatment of acute migraine in patients using topiramate for migraine prophylaxis. Rizatriptan was generally well tolerated in this population. These results are comparable with those from clinical trials in patients not using prophylaxis, suggesting that the use of topiramate does not affect the efficacy or tolerability of rizatriptan for acute migraine treatment.
评估利扎曲普坦口腔崩解片（ODT）治疗使用托吡酯预防偏头痛的患者急性偏头痛的疗效和耐受性。
在使用预防性药物的患者中经历偏头痛发作的情况下，来自前瞻性对照试验的有限数据证明了曲坦类药物的益处。
这是一项在患有偏头痛病史超过 1 年且正在使用托吡酯稳定剂量预防偏头痛且每月经历≥2 次中度/重度偏头痛发作的成年患者中进行的全球、随机、安慰剂对照、双盲、多次发作研究。参与者以交叉方式治疗 3 次中度/重度偏头痛发作（2 次用利扎曲坦 10mg ODT，1 次用安慰剂），随后根据 1 至 3 种治疗顺序随机分配。主要终点为 2 小时疼痛缓解。
与安慰剂相比，利扎曲坦 2 小时疼痛缓解显著更大（55.0%对 17.4%，P<.001）。反应率也有利于利扎曲坦持续缓解 2 至 24 小时的疼痛（32.6%对 11.1%，P<.001）、2 小时疼痛自由（36.0%对 6.5%，P<.001）、2 小时正常功能能力（42.2%对 12.7%，P<.001）和 24 小时整体治疗满意度（60.8%对 33.6%，P<.001）。少数参与者报告不良体验（利扎曲坦 16 例[15.8%]，安慰剂 3 例[3.2%]）；均不严重。
在使用托吡酯预防偏头痛的患者中，利扎曲坦 10mg ODT 在所有疼痛终点均优于安慰剂，用于治疗急性偏头痛。在该人群中，利扎曲坦通常具有良好的耐受性。这些结果与未使用预防药物的临床试验结果相当，表明托吡酯的使用不会影响利扎曲坦治疗急性偏头痛的疗效和耐受性。
