医学
安慰剂
偏头痛
相对风险
随机对照试验
置信区间
不利影响
食欲不振
入射(几何)
内科学
麻醉
替代医学
物理
病理
光学
作者
Vinay Suresh,Mainak Bardhan,Tirth Dave,Muhammad Aaqib Shamim,Dilip Suresh,S Poorvikha,Bishal Dhakal,Aman Bhonsale,Priyanka Roy,Bijaya Kumar Padhi,Teshamae Monteith
出处
期刊:Clinical Neuropharmacology
[Ovid Technologies (Wolters Kluwer)]
日期:2024-05-01
卷期号:47 (3): 72-81
被引量:1
标识
DOI:10.1097/wnf.0000000000000588
摘要
Objective Evaluate the safety and efficacy of zavegepant (BHV-3500), a recently approved nasal spray containing a third-generation calcitonin gene-related peptide receptor antagonist, for treating acute migraine attacks. Methods A comprehensive search was conducted across various databases up to 06/26/2023 to identify relevant randomized clinical trials (RCTs) on zavegepant's efficacy and safety in treatment of acute migraine attacks. Primary outcome: freedom from pain at 2 hours postdose. Safety outcomes were evaluated based on adverse events (AEs), with zavegepant 10 mg and placebo groups compared for incidence of AEs. Results Two RCTs, involving 2061 participants (1014 receiving zavegepant and 1047 receiving placebo), were quantitatively analyzed. An additional trial was included for qualitative synthesis. Zavegepant 10 mg exhibited a significantly higher likelihood of achieving freedom from pain at 2 hours postdose compared with the placebo group (risk ratio [RR] 1.54, 95% confidence interval [CI] 1.28 to 1.84). It also showed superior relief from the most bothersome symptoms at 2 hours postdose compared with placebo (RR 1.26, 95% CI 1.13 to 1.42). However, the zavegepant 10 mg group experienced a higher incidence of AEs compared with placebo (RR 1.78, 95% CI 1.5 to 2.12), with dysgeusia being the most reported AE (RR 4.18, 95% CI 3.05 to 5.72). Conclusion Zavegepant 10 mg is more effective than placebo in treating acute migraine attacks, providing compelling evidence of its efficacy in relieving migraine pain and most bothersome associated symptoms. Further trials are necessary to confirm its efficacy, tolerability, and safety in diverse clinic-based settings with varied patient populations.
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