RT期刊文章SR电子T1 Atogepant预防偏头痛治疗对Patient-Reported结果的影响的随机、双盲、第三阶段推进审判摩根富林明神经病学神经学乔FD Lippincott Williams &威尔金斯SP e764 OP e777 10.1212 / WNL。半岛投注体育官网100签证官0000000000201568 8 A1理查德·b·利普顿A1 Patricia Pozo-Rosich A1安德鲁·m·Blumenfeld A1叶莉A1劳伦斯Severt A1乔纳森·t·斯托克斯A1莱拉Creutz A1 Pranav甘地A1 David Dodick年2023 UL //www.ebmtp.com/content/100/8/e764.abstract AB背景和目标口服降钙素半岛投注体育官网相关基因肽受体拮抗剂atogepant表示情景性偏头痛的预防治疗。我们评估patient-reported变化结果与成人atogepant偏头痛。方法在这个阶段3、12周的多中心、随机、双盲、安慰剂对照、平行对照试验中(事先)学报》第4 - 14成人偏头痛天每月收到atogepant(10、30或60毫克)每天一次或安慰剂。二次端点包括从基线变化Migraine-Specific生活质量问卷(MSQ) 2.1版角色Function-Restrictive (RFR)域在第12周和月平均活动障碍Migraine-Diary (AIM-D)性能的日常活动(PDA)和物理障碍(PI)域在12周的治疗期。探索性端点包括改变MSQ角色Function-Preventive (RFP)和情感功能(EF)域;AIM-D总分;和头痛的变化冲击试验(打击)6分数。910名参与者随机分配的结果,873年由修改intent-to-treat人口(atogepant: 10毫克(n = 214);30毫克(n = 223); and 60 mg [n = 222]; placebo [n = 214]). All atogepant groups demonstrated significantly greater improvements vs placebo in MSQ RFR that exceeded minimum clinically meaningful between-group difference (3.2 points) at week 12 (least-square mean difference [LSMD] vs placebo: 10 mg [9.9]; 30 mg [10.1]; 60 mg [10.8]; all p < 0.0001). LSMDs in monthly AIM-D PDA and PI scores across the 12-week treatment period improved significantly for the atogepant 30 (PDA: −2.54; p = 0.0003; PI: −1.99; and p = 0.0011) and 60 mg groups (PDA: −3.32; p < 0.0001; PI: −2.46; p < 0.0001), but not for the 10 mg group (PDA: −1.19; p = 0.086; PI: −1.08; p = 0.074). In exploratory analyses, atogepant 30 and 60 mg were associated with nominal improvements in MSQ RFP and EF domains, other AIM-D outcomes, and HIT-6 scores at the earliest time point (week 4) and throughout the 12-week treatment period. Results varied for atogepant 10 mg.Discussion Atogepant 30 and 60 mg produced significant improvements in key patient-reported outcomes including MSQ-RFR scores and both AIM-D domains. Nominal improvements also occurred for other MSQ domains and HIT-6, reinforcing the beneficial effects of atogepant as a new treatment for migraine prevention.Trial Registration Information ClinicalTrials.gov NCT03777059. Submitted: December 13, 2018; First patient enrolled: December 14, 2018. clinicaltrials.gov/ct2/show/NCT03777059.Classification of Evidence This study provides Class II evidence that daily atogepant is associated with improvements in health-related quality-of-life measures in patients with 4–14 migraine days per month.AIM-D=Activity Impairment in Migraine–Diary; CGRP=calcitonin gene–related peptide; CM=chronic migraine; eDiary=electronic diary; EF=Emotional Function; EM=episodic migraine; eTablet=electronic tablet; HA=headache (day); HIT-6=Headache Impact Test–6; FDA=Food and Drug Administration; HRQoL=health-related quality of life; ICHD-3=International Classification of Headache Disorders, third edition; LSMD=least-square mean difference; mAb=monoclonal antibody; MID=minimally important difference; mITT=modified intent-to-treat; MHD=monthly headache day; MMD=monthly migraine days; MMRM=mixed models for repeated measure; MSQ v2.1=Migraine-Specific Quality-of-Life Questionnaire version 2.1; nHA=nonheadache (day); PDA=performance of daily activities; PI=physical impairment; PRO=patient-reported outcome; QD=once daily; RFP=Role Function–Preventive; RFR=Role Function–Restrictive

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