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Rizatriptan for treatment of acute migraine in patients taking topiramate for migraine prophylaxis

机译:利扎曲普坦治疗托吡酯预防偏头痛的急性偏头痛

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Objective.To assess efficacy and tolerability of rizatriptan orally disintegrating tablet (ODT) for treatment of acute migraine in patients using topiramate for migraine prophylaxis. Background.There are limited data from prospective controlled trials demonstrating the benefit of triptans in patients who experience migraine attacks while taking prophylactic medication. Methods.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 a¥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. Results.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. Conclusion.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.
机译:目的:评估利扎曲普坦口腔崩解片(ODT)在使用托吡酯预防偏头痛的患者中治疗急性偏头痛的疗效和耐受性。背景:前瞻性对照试验的数据有限,表明曲坦类药物在服用预防药物的偏头痛发作患者中的益处。方法:这是一项全球性,随机,安慰剂对照,双盲,多次发作的研究,研究对象是偏头痛已有1年以上历史的成年人,服用稳定剂量的托吡酯预防偏头痛,并经历了¥2的中度/重度发作每月。在随机分配给3个治疗序列中的1个之后,参与者以交叉方式治疗3次中度/重度发作(2次使用rizatriptan 10-mg ODT,1次使用安慰剂)。主要终点是2小时疼痛缓解。结果:与安慰剂相比,利扎曲坦的2小时止痛效果显着更大(55.0%对17.4%,P <.001)。缓解率也有利于利扎曲普坦2至24小时的持续缓解(32.6%比11.1%,P <.001),2小时的疼痛自由度(36.0%比6.5%,P <.001),2时正常功能小时(42.2%比12.7%,P <.001)和24小时总体治疗满意度(60.8%比33.6%,P <.001)。很少有参与者报告不良经历(利扎曲普坦有16 [15.8%],安慰剂有3 [3.2%]);没有一个是认真的。结论:在使用托吡酯预防偏头痛的急性偏头痛患者中,利扎曲普坦10mg ODT在所有疼痛终点均优于安慰剂。利扎曲普坦在该人群中一般耐受良好。这些结果与未进行预防的患者的临床试验结果相当,表明托吡酯的使用不会影响利扎曲普坦治疗急性偏头痛的疗效或耐受性。

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