Safety of Rimegepant in Adults with Migraine and Anxiety, Depression, or Using Antidepressants: Analysis of a Multicenter, Long-Term, Open-Label Study.

IF 4.1 2区医学 Q1 CLINICAL NEUROLOGY

Pain and Therapy Pub Date : 2024-11-09 DOI:10.1007/s40122-024-00675-6

David Kudrow, Susan Hutchinson, Glenn C Pixton, Terence Fullerton

{"title":"Safety of Rimegepant in Adults with Migraine and Anxiety, Depression, or Using Antidepressants: Analysis of a Multicenter, Long-Term, Open-Label Study.","authors":"David Kudrow, Susan Hutchinson, Glenn C Pixton, Terence Fullerton","doi":"10.1007/s40122-024-00675-6","DOIUrl":null,"url":null,"abstract":"Introduction: Anxiety and depression are frequently associated with migraine, and antidepressant use can complicate treatment. These analyses assessed the safety and tolerability of rimegepant in participants with migraine and anxiety and/or depression, or using selective serotonin reuptake inhibitors (SSRIs) and/or other antidepressants.Methods: Data were from a phase II/III safety study of rimegepant for the acute treatment of migraine. Participants with a history of 2-14 migraine attacks per month of moderate or severe pain intensity self-administered rimegepant 75 mg as needed up to once daily for up to 52 weeks. These post hoc subgroup analyses assessed safety according to self-reported history of anxiety (yes or no) or depression (yes or no), and current use of SSRIs (yes or no) or other antidepressants (yes or no).Results: Of 1800 treated participants, 23.2% (n = 417) had a self-reported history of anxiety, 23.7% (n = 426) had a self-reported history of depression, and 11.2% (n = 202) reported both anxiety and depression. A total of 10.1% (n = 181) of participants were using an SSRI, 10.8% (n = 195) were using other antidepressants, and 1.8% (n = 32) were using both. Across the subgroups with anxiety, without anxiety, with depression, without depression, using SSRIs, not using SSRIs, using other antidepressants, and not using other antidepressants, respectively, similar proportions of participants reported adverse events (67.1%, 58.4%, 62.0%, 60.0%, 64.1%, 60.0%, 66.2%, 59.8%), serious adverse events (3.6%, 2.3%, 2.8%, 2.5%, 3.3%, 2.5%, 5.1%, 2.3%), and discontinuation of rimegepant due to adverse events (4.1%, 2.2%, 3.1%, 2.5%, 5.0%, 2.4%, 3.1%, 2.6%). Numerical improvements in a variety of participant-reported outcomes were also observed at weeks 12 and 52.Conclusions: Rimegepant showed favorable safety and tolerability in adults with migraine and a history of anxiety and/or depression and with SSRI and/or other antidepressant use.Trial registration: Clinicaltrials.gov: NCT03266588.","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.1000,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pain and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40122-024-00675-6","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

Introduction: Anxiety and depression are frequently associated with migraine, and antidepressant use can complicate treatment. These analyses assessed the safety and tolerability of rimegepant in participants with migraine and anxiety and/or depression, or using selective serotonin reuptake inhibitors (SSRIs) and/or other antidepressants.

Methods: Data were from a phase II/III safety study of rimegepant for the acute treatment of migraine. Participants with a history of 2-14 migraine attacks per month of moderate or severe pain intensity self-administered rimegepant 75 mg as needed up to once daily for up to 52 weeks. These post hoc subgroup analyses assessed safety according to self-reported history of anxiety (yes or no) or depression (yes or no), and current use of SSRIs (yes or no) or other antidepressants (yes or no).

Results: Of 1800 treated participants, 23.2% (n = 417) had a self-reported history of anxiety, 23.7% (n = 426) had a self-reported history of depression, and 11.2% (n = 202) reported both anxiety and depression. A total of 10.1% (n = 181) of participants were using an SSRI, 10.8% (n = 195) were using other antidepressants, and 1.8% (n = 32) were using both. Across the subgroups with anxiety, without anxiety, with depression, without depression, using SSRIs, not using SSRIs, using other antidepressants, and not using other antidepressants, respectively, similar proportions of participants reported adverse events (67.1%, 58.4%, 62.0%, 60.0%, 64.1%, 60.0%, 66.2%, 59.8%), serious adverse events (3.6%, 2.3%, 2.8%, 2.5%, 3.3%, 2.5%, 5.1%, 2.3%), and discontinuation of rimegepant due to adverse events (4.1%, 2.2%, 3.1%, 2.5%, 5.0%, 2.4%, 3.1%, 2.6%). Numerical improvements in a variety of participant-reported outcomes were also observed at weeks 12 and 52.

Conclusions: Rimegepant showed favorable safety and tolerability in adults with migraine and a history of anxiety and/or depression and with SSRI and/or other antidepressant use.

Trial registration: Clinicaltrials.gov: NCT03266588.

查看原文本刊更多论文

Rimegepant 对患有偏头痛、焦虑症、抑郁症或服用抗抑郁药的成人的安全性：一项多中心、长期、开放标签研究的分析。

简介：焦虑和抑郁常常与偏头痛有关，使用抗抑郁药会使治疗复杂化。这些分析评估了利美昔班对患有偏头痛、焦虑症和/或抑郁症，或正在使用选择性血清素再摄取抑制剂（SSRIs）和/或其他抗抑郁药的患者的安全性和耐受性：数据来自于利美泮急性治疗偏头痛的II/III期安全性研究。参与者每月偏头痛发作2-14次，疼痛强度为中度或重度，可根据需要自行服用75毫克利美君，最多每天一次，持续52周。这些事后分组分析根据自我报告的焦虑史（是或否）或抑郁史（是或否）以及目前使用的 SSRIs（是或否）或其他抗抑郁药（是或否）来评估安全性：在接受治疗的 1800 名参与者中，23.2%（417 人）自述有焦虑病史，23.7%（426 人）自述有抑郁病史，11.2%（202 人）自述既有焦虑又有抑郁。共有 10.1%（n = 181）的参与者使用 SSRI，10.8%（n = 195）的参与者使用其他抗抑郁药物，1.8%（n = 32）的参与者同时使用这两种药物。在有焦虑、无焦虑、有抑郁、无抑郁、使用 SSRIs、未使用 SSRIs、使用其他抗抑郁药和未使用其他抗抑郁药的亚组中，报告不良事件的参与者比例相似（67.1%、58.4%、62.0%、60.0%、64.1%、60.0%、66.2%、59.8%）、严重不良事件（3.6%、2.3%、2.8%、2.5%、3.3%、2.5%、5.1%、2.3%）以及因不良事件而停用利美君（4.1%、2.2%、3.1%、2.5%、5.0%、2.4%、3.1%、2.6%）。在第12周和第52周，还观察到参与者报告的各种结果均有数字上的改善：结论：Rimegepant对患有偏头痛、焦虑和/或抑郁症以及使用SSRI和/或其他抗抑郁药的成人具有良好的安全性和耐受性：试验注册：Clinicaltrials.gov：试验注册：Clinicaltrials.gov：NCT03266588。

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

Pain and Therapy CLINICAL NEUROLOGY-

CiteScore

6.60

自引率

5.00%

发文量

110

审稿时长

6 weeks

期刊介绍： Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.