Effect of preventive treatment with atogepant on quality of life, daily functioning, and headache impact across the spectrum of migraine: Findings from three double-blind, randomized, phase 3 trials.

IF 5 2区医学 Q1 CLINICAL NEUROLOGY

Cephalalgia Pub Date : 2024-12-01 DOI:10.1177/03331024241300305

Christopher Gottschalk, Pranav Gandhi, Patricia Pozo-Rosich, Suzanne Christie, Cristina Tassorelli, Jonathan Stokes, Yingyi Liu, Lei Luo, Krisztian Nagy, Joel M Trugman, Richard B Lipton

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引用次数: 0

Abstract

Background: We aimed to assess the effects of preventive migraine treatment with atogepant vs. placebo on patient-reported quality of life and functioning.

Methods: 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).

Results: Least squares mean differences (95% confidence interval (CI)) in change from baseline were greater (p < 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)).

Conclusions: 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.Trial Registration: ClinicalTrials.gov: NCT03777059 (ADVANCE); NCT03855137 (PROGRESS); NCT04740827 (ELEVATE).

查看原文本刊更多论文

预防治疗对生活质量、日常功能和偏头痛的影响：来自三个双盲、随机、3期试验的结果。

背景：我们的目的是评估抗偏头痛治疗与安慰剂对患者报告的生活质量和功能的影响。方法：分析患者报告的三个12周、随机、安慰剂对照试验的结果，这些试验评估了使用atgeatement 60mg每日一次的预防性偏头痛治疗：ADVANCE（低频发作性偏头痛[LFEM]，每月偏头痛4-8天[MMDs]和高频发作性偏头痛[HFEM]， 8-14 MMDs）、PROGRESS（慢性偏头痛，CM）和ELEVATE（先前口服预防治疗失败的患者的发作性偏头痛）。结果：与基线相比，最小二乘平均差异（95%置信区间（CI））更大(p)。结论：在不同头痛频率和既往治疗失败史的参与者中，与安慰剂相比，使用atgeatine 60mg每日一次的预防性偏头痛治疗改善了偏头痛相关生活质量和功能的测量。试验注册：ClinicalTrials.gov: NCT03777059 (ADVANCE)；NCT03855137(进步);NCT04740827(提升)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cephalalgia 医学-临床神经学

CiteScore

10.10

自引率

6.10%

发文量

108

审稿时长

4-8 weeks

期刊介绍： Cephalalgia contains original peer reviewed papers on all aspects of headache. The journal provides an international forum for original research papers, review articles and short communications. Published monthly on behalf of the International Headache Society, Cephalalgia''s rapid review averages 5 ½ weeks from author submission to first decision.