Comparative efficacy, quality of life, safety, and tolerability of atogepant and rimegepant in migraine prevention: A matching-adjusted indirect comparison analysis.

IF 5 2区医学 Q1 CLINICAL NEUROLOGY

Cephalalgia Pub Date : 2024-02-01 DOI:10.1177/03331024241235156

Cristina Tassorelli, Kateryna Onishchenko, Rashmi B Halker Singh, Molly Duan, Laure Dupont-Benjamin, Matthew Hemstock, Corey Voller, Peter McAllister, Stephanie J Nahas, Pranav Gandhi, Jessica Ailani

{"title":"Comparative efficacy, quality of life, safety, and tolerability of atogepant and rimegepant in migraine prevention: A matching-adjusted indirect comparison analysis.","authors":"Cristina Tassorelli, Kateryna Onishchenko, Rashmi B Halker Singh, Molly Duan, Laure Dupont-Benjamin, Matthew Hemstock, Corey Voller, Peter McAllister, Stephanie J Nahas, Pranav Gandhi, Jessica Ailani","doi":"10.1177/03331024241235156","DOIUrl":null,"url":null,"abstract":"Background: Comparative evaluations of preventive migraine treatments can help inform clinical decision making for managing migraine in clinical practice.Methods: An anchored matching-adjusted indirect comparison analysis was conducted using pooled participant-level data from two phase 3 atogepant trials (ADVANCE and PROGRESS) and one phase 2/3 rimegepant trial (BHV3000-305) to evaluate the relative efficacy and safety/tolerability of atogepant and rimegepant as preventive migraine treatments. Participants receiving atogepant 60 mg once daily, rimegepant orally disintegrating tablet 75 mg once every other day, and placebo were included. Only participants meeting the BHV3000-305 inclusion/exclusion criteria were analyzed: ≥6 monthly migraine days and ≤18 monthly headache days at baseline. The primary efficacy assessment of interest was change in monthly migraine days across weeks 1-12.Results: There were 252 participants in the atogepant group and 348 in the rimegepant group. Across weeks 1-12, atogepant 60 mg demonstrated a significantly greater reduction in mean monthly migraine days compared with rimegepant 75 mg (mean difference [95% CI]: -1.65 [-2.49, -0.81]; p < 0.001). Both atogepant and rimegepant demonstrated similar safety/tolerability profiles.Conclusion: In this matching-adjusted indirect comparison analysis, oral atogepant 60 mg once daily demonstrated a significantly greater reduction in monthly migraine days compared with rimegepant 75 mg orally disintegrating tablet once every other day.","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":null,"pages":null},"PeriodicalIF":5.0000,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cephalalgia","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/03331024241235156","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background: Comparative evaluations of preventive migraine treatments can help inform clinical decision making for managing migraine in clinical practice.

Methods: An anchored matching-adjusted indirect comparison analysis was conducted using pooled participant-level data from two phase 3 atogepant trials (ADVANCE and PROGRESS) and one phase 2/3 rimegepant trial (BHV3000-305) to evaluate the relative efficacy and safety/tolerability of atogepant and rimegepant as preventive migraine treatments. Participants receiving atogepant 60 mg once daily, rimegepant orally disintegrating tablet 75 mg once every other day, and placebo were included. Only participants meeting the BHV3000-305 inclusion/exclusion criteria were analyzed: ≥6 monthly migraine days and ≤18 monthly headache days at baseline. The primary efficacy assessment of interest was change in monthly migraine days across weeks 1-12.

Results: There were 252 participants in the atogepant group and 348 in the rimegepant group. Across weeks 1-12, atogepant 60 mg demonstrated a significantly greater reduction in mean monthly migraine days compared with rimegepant 75 mg (mean difference [95% CI]: -1.65 [-2.49, -0.81]; p < 0.001). Both atogepant and rimegepant demonstrated similar safety/tolerability profiles.

Conclusion: In this matching-adjusted indirect comparison analysis, oral atogepant 60 mg once daily demonstrated a significantly greater reduction in monthly migraine days compared with rimegepant 75 mg orally disintegrating tablet once every other day.

查看原文本刊更多论文

阿托吉潘和利美昔康预防偏头痛的疗效、生活质量、安全性和耐受性比较：匹配调整间接比较分析。

背景：偏头痛预防性治疗方法的比较评估有助于为临床实践中管理偏头痛的临床决策提供依据：利用两项阿托吉潘三期试验（ADVANCE和PROGRESS）和一项利美昔班二期/三期试验（BHV3000-305）的参与者水平数据进行了锚定匹配调整间接比较分析，以评估阿托吉潘和利美昔班作为偏头痛预防性治疗方法的相对疗效和安全性/耐受性。研究对象包括每日一次服用阿托吉潘 60 毫克、隔日一次服用利美昔康口腔崩解片 75 毫克和安慰剂的患者。只有符合BHV3000-305纳入/排除标准的参试者才被纳入分析范围：基线时每月偏头痛天数≥6天，每月头痛天数≤18天。主要疗效评估是第1-12周每月偏头痛天数的变化：结果：阿托格班组有252名参与者，利美昔班组有348名参与者。在第 1-12 周内，阿托吉潘 60 毫克与利美君 75 毫克相比，每月偏头痛的平均发病天数明显减少（平均差异 [95% CI]：-1.65 [-2.49, -0.81]；P 结论：阿托吉潘 60 毫克与利美君 75 毫克相比，每月偏头痛的平均发病天数明显减少：在这项匹配调整后的间接比较分析中，与利美喷75毫克口腔崩解片相比，口服阿托吉潘60毫克，每天一次，与利美喷75毫克口腔崩解片相比，每月偏头痛天数的减少幅度明显更大。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

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.