Zavegepant for Acute Treatment of Migraine: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

IF 0.8 4区医学 Q4 CLINICAL NEUROLOGY Clinical Neuropharmacology Pub Date : 2024-05-01 DOI:10.1097/WNF.0000000000000588

Vinay Suresh, Mainak Bardhan, Tirth Dave, Muhammad Aaqib Shamim, Dilip Suresh, Poorvikha Satish, Bishal Dhakal, Aman Bhonsale, Priyanka Roy, Bijaya Kumar Padhi, Teshamae Monteith

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Abstract

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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用于偏头痛急性期治疗的 Zavegepant：随机对照试验的系统回顾和元分析》。

目的：评估zavegepant（BHV-3500）的安全性和有效性：评估zavegepant（BHV-3500）治疗急性偏头痛发作的安全性和有效性：方法：对截至 2023 年 6 月 26 日的各种数据库进行了全面检索，以确定有关 zavegepant 治疗急性偏头痛发作的有效性和安全性的相关随机临床试验 (RCT)。主要结果：服药后2小时无疼痛。根据不良事件（AEs）评估安全性结果，比较zavegepant 10毫克组和安慰剂组的AEs发生率：对涉及 2061 名参与者（1014 人接受扎韦格潘治疗，1047 人接受安慰剂治疗）的两项 RCT 进行了定量分析。另外还纳入了一项试验进行定性综合分析。与安慰剂组相比，10 毫克扎韦吉潘在服药后 2 小时达到无痛的可能性明显更高（风险比 [RR] 1.54，95% 置信区间 [CI] 1.28 至 1.84）。此外，与安慰剂组相比，扎韦吉潘特在用药后 2 小时内对最令人烦恼的症状的缓解效果也更佳（风险比为 1.26，95% 置信区间为 1.13 至 1.42）。然而，与安慰剂相比，zavegepant 10 mg组的AE发生率更高（RR为1.78，95% CI为1.5至2.12），其中呕吐困难是报告最多的AE（RR为4.18，95% CI为3.05至5.72）：结论：Zavegepant 10 毫克在治疗偏头痛急性发作方面比安慰剂更有效，为其缓解偏头痛疼痛和最令人烦恼的相关症状提供了令人信服的证据。有必要进行进一步试验，以确认其在不同临床环境和不同患者群体中的疗效、耐受性和安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Neuropharmacology 医学-临床神经学

CiteScore

1.20

自引率

10.00%

发文量

审稿时长

6-12 weeks

期刊介绍： Clinical Neuropharmacology is a peer-reviewed journal devoted to the pharmacology of the nervous system in its broadest sense. Coverage ranges from such basic aspects as mechanisms of action, structure-activity relationships, and drug metabolism and pharmacokinetics, to practical clinical problems such as drug interactions, drug toxicity, and therapy for specific syndromes and symptoms. The journal publishes original articles and brief reports, invited and submitted reviews, and letters to the editor. A regular feature is the Patient Management Series: in-depth case presentations with clinical questions and answers.