@article {Liptone764作者={理查德·b·利普顿和帕特丽夏Pozo-Rosich和安德鲁·m·Blumenfeld和叶莉和劳伦斯Severt乔纳森·t·斯托克斯和莱拉·Creutz Pranav甘地和David Dodick}, title = {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},体积={100}={8},页面= {e764——e777} = {2023}, doi = {10.1212 / WNL。出版商0000000000201568}= {Wolters Kluwer健康,公司代表美国神经病学学会},文摘={背景和目标口服降钙素基因相关肽受体拮抗剂atogepant {\ texten半岛投注体育官网dash}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(提前),成人偏头痛4 {\ textendash} 14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版本的作用函数{\ textendash}限制性(RFR)域在第12周和月平均活动障碍偏头痛{\ textendash}日记(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作用函数{\ textendash}预防(RFP)和情感功能(EF)域;AIM-D总分;头痛和变化冲击试验(打击){\ textendash} 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);和60毫克(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{\textendash}14 migraine days per month.AIM-D=Activity Impairment in Migraine{\textendash}Diary; CGRP=calcitonin gene{\textendash}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{\textendash}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{\textendash}Preventive; RFR=Role Function{\textendash}Restrictive}, issn = {0028-3878}, URL = {//www.ebmtp.com/content/100/8/e764}, eprint = {//www.ebmtp.com/content/100/8/e764.full.pdf}, journal = {Neurology} }