"Efficacy and safety of eptinezumab in patients with chronic migraine and medication-overuse headache: a randomized, double-blind, placebo-controlled study"

作者全名："Yu, Shengyuan; Zhou, Jiying; Luo, Guogang; Xiao, Zheman; Ettrup, Anders; Jansson, Gary; Florea, Ioana; Ranc, Kristina; Pozo-Rosich, Patricia"

作者地址："[Yu, Shengyuan] Chinese Peoples Liberat Army Gen Hosp, Dept Neurol, Beijing, Peoples R China; [Zhou, Jiying] Chongqing Med Univ, Affiliated Hosp 1, Dept Neurol, Chongqing, Peoples R China; [Luo, Guogang] Xi An Jiao Tong Univ, Affiliated Hosp 1, Neurol Dept, Xian, Peoples R China; [Xiao, Zheman] Wuhan Univ, Renmin Hosp, Dept Neurol, Wuhan, Peoples R China; [Ettrup, Anders; Jansson, Gary; Florea, Ioana; Ranc, Kristina] H Lundbeck & Co AS, Copenhagen, Denmark; [Pozo-Rosich, Patricia] Vall dHebron Univ Hosp, Neurol Dept, Headache Unit, Barcelona, Spain; [Pozo-Rosich, Patricia] Univ Autonoma Barcelona, Vall dHebron Res Inst, Dept Med, Headache & Neurol Pain Res Grp, Barcelona, Spain"

通信作者："Yu, SY (通讯作者)，Chinese Peoples Liberat Army Gen Hosp, Dept Neurol, Beijing, Peoples R China."

来源：BMC NEUROLOGY

ESI学科分类：NEUROSCIENCE & BEHAVIOR

WOS号：WOS:001125481000003

JCR分区：Q3

影响因子：2.2

年份：2023

卷号：23

期号：1

开始页：　

结束页：　

文献类型：Article

关键词：Chronic migraine; Medication-overuse headache; Anti-CGRP; Eptinezumab; Preventive migraine treatment

摘要："BackgroundFor some people with migraine, despite taking greater amounts of acute headache medication (AHM), they develop an increase in monthly headache days. This cycle of increasing headache days, and in turn AHM use, can lead to a secondary headache disorder called medication-overuse headache (MOH). Preventive medications can prevent migraine from occurring and reduce reliance on AHMs, thereby preventing the cycle of MOH. This study was performed to evaluate the efficacy and safety of eptinezumab to prevent migraine/headache in a mainly Asian patient population with a dual diagnosis of chronic migraine and MOH.MethodsSUNLIGHT was a phase 3, multicenter, double-blind, parallel-group, placebo-controlled trial. Patients aged 18-75 years with >= 8 migraine days/month and a diagnosis of MOH were randomly allocated (1:1) to one of two treatment groups: eptinezumab 100 mg or placebo. Monthly migraine days (MMDs) were captured using a daily electronic diary; the change from baseline in the number of MMDs over Weeks 1-12 was the primary efficacy endpoint.ResultsPatients were randomized to eptinezumab 100 mg (n = 93) or placebo (n = 100). Over Weeks 1-12, eptinezumab reduced mean MMDs more than placebo (difference between treatments was -1.2; p = 0.1484). Differences between treatment groups with p-values below 0.05 favoring eptinezumab were observed in 3 out of the 6 key secondary endpoints.ConclusionAll endpoints numerically favored eptinezumab treatment when compared to placebo; however, this study did not meet its primary endpoint and is therefore negative. No new safety signals were identified in this study, like previous reports that confirmed the safety and tolerability of eptinezumab treatment.Trial registrationClinicalTrials.gov identifier: NCT04772742 (26/02/2021)."

基金机构："H. Lundbeck A/S (Copenhagen, Denmark)"

基金资助正文："The authors thank the participants of this study. The authors also thank Julia L. Jones, PhD and Nicole Coolbaugh, CMPP of The Medicine Group, LLC (New Hope, PA, United States) for providing medical writing support, which was funded by H. Lundbeck A/S (Copenhagen, Denmark) and in accordance with Good Publication Practice guidelines."