Gottschalk Christopher, Gandhi Pranav, Pozo-Rosich Patricia, Christie Suzanne, Tassorelli Cristina, Stokes Jonathan, Liu Yingyi, Luo Lei, Nagy Krisztian, Trugman Joel M, Lipton Richard B
Yale Medicine Department of Neurology, New Haven, CT, USA.
AbbVie, North Chicago, IL, USA.
Cephalalgia. 2024 Dec;44(12):3331024241300305. doi: 10.1177/03331024241300305.
We aimed to assess the effects of preventive migraine treatment with atogepant vs. placebo on patient-reported quality of life and functioning.
Analyses of patient-reported outcomes from three 12-week, randomized, placebo-controlled trials evaluating preventive migraine treatment with atogepant 60 mg once-daily: ADVANCE (low-frequency episodic migraine [LFEM], 4-8 monthly migraine days [MMDs] and high-frequency episodic migraine [HFEM], 8-14 MMDs), PROGRESS (chronic migraine, CM) and ELEVATE (episodic migraine in those previously failed by two to four classes of oral preventive treatments).
Least squares mean differences (95% confidence interval (CI)) in change from baseline were greater (< 0.05) for atogepant vs. placebo for Migraine-Specific Quality of Life questionnaire Role Function-Restrictive domain scores at week 12 (ADVANCE: LFEM 12.0 (95% CI = 6.0-18.0), HFEM 9.9 (95% CI = 3.4-16.4); PROGRESS: 6.2 (95% CI = 2.5-9.8); ELEVATE: 17.7 (95% CI = 13.1-22.3)), for Headache Impact Test-6 total scores at week 12 (ADVANCE: LFEM -4.7 (95% CI = -6.7 to -2.7); HFEM -3.4 (95% CI = -5.5 to -1.2); PROGRESS: -2.8 (95% CI = -4.1 to -1.4); ELEVATE: -6.5 (95% CI = -8.3 to -4.7)) and for Activity Impairment in Migraine-Diary-Performance of Daily Activities scores across 12 weeks (ADVANCE: LFEM -2.3 (95% CI = -3.9 to -0.7), HFEM -4.5 (95% CI = -6.9 to -2.2); PROGRESS: -3.4 (95% CI = -5.3 to -1.5); ELEVATE: -4.7 (95% CI = -6.4 to -3.1)).
Preventive migraine treatment with atogepant 60 mg once-daily vs. placebo improved measures of migraine-related quality of life and functioning among participants with different headache frequencies and histories of previous treatment failure. ClinicalTrials.gov: NCT03777059 (ADVANCE); NCT03855137 (PROGRESS); NCT04740827 (ELEVATE).
我们旨在评估阿托格潘与安慰剂预防性治疗偏头痛对患者报告的生活质量和功能的影响。
对三项为期12周的随机、安慰剂对照试验的患者报告结局进行分析，这些试验评估了每日一次60毫克阿托格潘预防性治疗偏头痛的效果：ADVANCE（低频发作性偏头痛[LFEM]，每月偏头痛天数[MMD]为4 - 8天，以及高频发作性偏头痛[HFEM]，MMD为8 - 14天）、PROGRESS（慢性偏头痛，CM）和ELEVATE（曾接受过两到四类口服预防性治疗但失败的发作性偏头痛患者）。
在第12周时，阿托格潘组与安慰剂组相比，偏头痛特异性生活质量问卷角色功能 - 限制领域得分从基线的变化的最小二乘均值差异（95%置信区间[CI]）更大（<0.05）（ADVANCE：LFEM为12.0（95%CI = 6.0 - 18.0），HFEM为9.9（95%CI = 3.4 - 16.4）；PROGRESS：6.2（95%CI = 2.5 - 9.8）；ELEVATE：17.7（95%CI = 13.1 - 22.3）），头痛影响测试 - 6总分在第12周时（ADVANCE：LFEM为 - 4.7（95%CI = - 6.7至 - 2.7）；HFEM为 - 3.4（95%CI = - 5.5至 - 1.2）；PROGRESS： - 2.8（95%CI = - 4.1至 - 1.4）；ELEVATE： - 6.5（95%CI = - 8.3至 - 4.7））以及12周内偏头痛日记 - 日常活动表现中的活动障碍得分（ADVANCE：LFEM为 - 2.3（95%CI = - 3.9至 - 0.7），HFEM为 - 4.5（95%CI = - 6.9至 - 2.2）；PROGRESS： - 3.4（95%CI = - 5.3至 - 1.5）；ELEVATE： - 4.7（95%CI = - 6.4至 - 3.1））。
每日一次60毫克阿托格潘预防性治疗偏头痛与安慰剂相比，改善了不同头痛频率和既往治疗失败史的参与者中与偏头痛相关生活质量和功能的指标。ClinicalTrials.gov：NCT03777059（ADVANCE）；NCT03855137（PROGRESS）；NCT04740827（ELEVATE）。
