Rimegepant orally disintegrating tablet 75 mg for acute treatment of migraine in adults from China: a subgroup analysis of a double-blind, randomized, placebo-controlled, phase 3 clinical trial

作者全名：Yu, Shengyuan; Guo, Aihong; Wang, Zhen; Liu, Jianguang; Tan, Ge; Yang, Qian; Zhang, Mingjie; Yibulaiyin, Hasiyeti; Chen, Huisheng; Zhang, Yongbo; Croop, Robert; Sun, Yanhui; Liu, Yu; Zhao, Qian; Lu, Zhihong

作者地址：[Yu, Shengyuan; Zhang, Mingjie] Chinese Peoples Liberat Army Gen Hosp, Beijing, Peoples R China; [Guo, Aihong] Yan An Univ, Xianyang Hosp, Xianyang, Peoples R China; [Wang, Zhen] Changsha Cent Hosp, Changsha, Peoples R China; [Liu, Jianguang] Wuhan Third Hosp, Wuhan, Peoples R China; [Tan, Ge] Chongqing Med Univ, Affiliated Hosp 1, Chongqing, Peoples R China; [Yang, Qian] Shaanxi Prov Hosp, Xian, Peoples R China; [Yibulaiyin, Hasiyeti] Xinjiang Med Univ, Affiliated Hosp 2, Urumqi, Xinjiang, Peoples R China; [Chen, Huisheng] Gen Hosp Northern Theater Command, Shenyang, Liaoning, Peoples R China; [Zhang, Yongbo] Capital Med Univ, Beijing Friendship Hosp, Beijing, Peoples R China; [Croop, Robert] Biohaven Pharmaceut, New Haven, CT USA; [Sun, Yanhui; Lu, Zhihong] Pfizer China Res & Dev Co Ltd, Shanghai 201203, Peoples R China; [Liu, Yu] Pfizer Inc, Beijing, Peoples R China; [Zhao, Qian] Pfizer Inc, Chengdu, Peoples R China

通信作者：Lu, ZH (通讯作者)，Pfizer China Res & Dev Co Ltd, Shanghai 201203, Peoples R China.

来源：JOURNAL OF HEADACHE AND PAIN

ESI学科分类：NEUROSCIENCE & BEHAVIOR

WOS号：WOS:001204502400001

JCR分区：Q1

影响因子：7.3

年份：2024

卷号：25

期号：1

开始页：　

结束页：　

文献类型：Article

关键词：Rimegepant; Migraine; Acute treatment; China; Clinical trial

摘要：Background Rimegepant orally disintegrating tablet (ODT), an oral small-molecule calcitonin gene-related peptide receptor antagonist, is indicated for acute and preventive treatment of migraine in the United States and other countries. Previously, a large clinical trial assessed the efficacy and safety of rimegepant ODT 75 mg for the acute treatment of migraine in adults living in China or South Korea. A post hoc subgroup analysis of this trial was performed to evaluate the efficacy and safety of rimegepant for acute treatment of migraine in adults living in China. Methods Eligible participants were >= 18 years of age and had a >= 1-year history of migraine, with 2 to 8 attacks of moderate or severe pain intensity per month and < 15 headache days per month during the 3 months before screening. Participants self-administered rimegepant ODT 75 mg or matching placebo to treat a single migraine attack of moderate or severe pain intensity. The co-primary endpoints were pain freedom and freedom from the most bothersome symptom (MBS) at 2 h post-dose. Key secondary endpoints included pain relief at 2 h post-dose, ability to function normally at 2 h post-dose, use of rescue medication within 24 h post-dose, and sustained pain freedom from 2 to 24 h and 2 to 48 h post-dose. All p values were nominal. Safety was assessed via treatment-emergent adverse events (TEAEs), electrocardiograms, vital signs, and routine laboratory tests. Results Overall, 1075 participants (rimegepant, n = 538; placebo, n = 537) were included in the subgroup analysis. Rimegepant was more effective than placebo for the co-primary endpoints of pain freedom (18.2% vs. 10.6%, p = 0.0004) and freedom from the MBS (48.0% vs. 31.8%, p < 0.0001), as well as all key secondary endpoints. The incidence of TEAEs was comparable between the rimegepant (15.2%) and placebo (16.4%) groups. No signal of drug-induced liver injury was observed, and no study drug-related serious TEAEs were reported in the rimegepant group. Conclusions A single dose of rimegepant 75 mg rimegepant was effective for the acute treatment of migraine in adults living in China, with safety and tolerability similar to placebo.

基金机构：Pfizer

基金资助正文：Medical writing support was provided by Matt Soulsby, PhD, CMPP, of Engage Scientific Solutions and was funded by Pfizer. The authors thank the study participants, investigators, and study site staff.