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首页> 外文期刊>The Canadian Journal of Neurological Sciences: le Journal Canadien des Sciences Neurologiques >A.07 Efficacy, safety, and tolerability of ubrogepant for the acute treatment of migraine: a single-attack phase 3 study, ACHIEVE I
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A.07 Efficacy, safety, and tolerability of ubrogepant for the acute treatment of migraine: a single-attack phase 3 study, ACHIEVE I

机译：A.07互脑膜对偏头痛急性治疗的疗效，安全性和耐受性：一次攻击第3期研究，实现I

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Background: To evaluate efficacy, safety, and tolerability of ubrogepant, an oral CGRP receptor antagonist, for acute treatment of a single migraine attack. Methods: Multicenter, randomized, double-blind, placebo-controlled, parallel-group, single-attack, phase 3 study (NCT02828020). Patients randomized 1:1:1 to placebo, ubrogepant 50mg, or ubrogepant 100mg had 60 days to treat one migraine attack (moderate/severe pain intensity). Co-primary efficacy endpoints: pain freedom 2 hours post initial dose and absence of most bothersome migraine-associated symptom (MBS). Results: 1672 patients were randomized (safety population: n=1436; mITT population: n=1327). Mean age: 40.7 years; white (82.4%); female (87.5%). A significantly greater percentage of ubrogepant- than placebo-treated patients achieved pain freedom 2 hours post initial dose (50mg: 19.2%, adjusted P=0.0023; 100mg: 21.2%, adjusted P=0.0003; placebo: 11.8%). A significantly greater percentage of ubrogepant patients achieved absence of MBS (50mg: 38.6%, adjusted P=0.0023, 100mg: 37.7%, adjusted P=0.0023; placebo: 27.8%). The adverse event (AE) profile of ubrogepant was similar to placebo. The most common AEs (incidence ≥2% in any treatment group) within 48 hours of initial or optional second dose were nausea, somnolence, and dry mouth (all with incidence <5%). Conclusions: Both co-primary endpoints were met, with clinically meaningful effects on migraine headache pain and MBS. Ubrogepant was well tolerated, with no identified safety concerns.
机译：背景技术：为了评估乌布地球菌，口腔CGRP受体拮抗剂的疗效，安全性和耐受性，用于急性治疗单一偏头痛的侵袭。方法：多中心，随机，双盲，安慰剂控制，并联，单攻，第3阶段研究（NCT02828020）。患者随机1：1：1至安慰剂，乌布地穴50mg或ubrogepant 100mg患有60天以治疗一种偏头痛（中等/剧烈疼痛强度）。共同初级疗效终点：疼痛自由2小时后初始剂量和缺乏大多数偏头骨相关症状（MBS）。结果：1672例患者随机（安全人群：N = 1436;米特人群：N = 1327）。意思是年龄：40.7岁;白色（82.4％）;女性（87.5％）。比安慰剂治疗的患者显着更大百分比才能实现疼痛自由2小时初始剂量后2小时（50mg：19.2％，调节的p = 0.0023; 100mg：21.2％，调节的p = 0.0003;安慰剂：11.8％）。较大百分比百分比的乌布地神经患者达到MBS（50mg：38.6％，调节的P = 0.0023，100mg：37.7％，调节的P = 0.0023;安慰剂：27.8％）。 ubrogepant的不良事件（ae）概况类似于安慰剂。在初始或可选的第二剂量的48小时内最常见的AES（任何治疗组中的发病率≥2％）是恶心，嗜睡和干燥口（均具有入射率<5％）。结论：满足了共同初级终点，对临床有意义对偏头痛性疼痛和MBS的影响。乌布地养病是耐受性的，没有确定的安全问题。

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