阿托格潘预防成人发作性偏头痛：疗效与安全性的系统评价和荟萃分析
Atogepant for the Prevention of Episodic Migraine in Adults: A Systematic Review and Meta-Analysis of Efficacy and Safety.
作者信息
Lattanzi Simona, Trinka Eugen, Altamura Claudia, Del Giovane Cinzia, Silvestrini Mauro, Brigo Francesco, Vernieri Fabrizio
机构信息
Department of Experimental and Clinical Medicine, Neurological Clinic, Marche Polytechnic University, Via Conca 71, 60020, Ancona, Italy.
Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria.
出版信息
Neurol Ther. 2022 Sep;11(3):1235-1252. doi: 10.1007/s40120-022-00370-8. Epub 2022 Jun 15.
INTRODUCTION
The inhibition of the calcitonin gene-related peptide (CGRP) pathway has attracted interest in pharmacological research on migraine. Atogepant is a potent, selective, orally available antagonist of the CGRP receptor approved as a preventive treatment of episodic migraine. This systematic review with meta-analysis aims to evaluate the efficacy and safety of atogepant for the prevention of episodic migraine in adult patients.
METHODS
Randomized, placebo-controlled, single or double-blinded trials were identified through a systematic literature search (December week 4, 2021). Main outcomes included the changes from baseline in monthly migraine days and the incidence of adverse events (AEs) and treatment withdrawal due to AEs. Mean difference (MD) and risk ratio (RR) with 95% confidence intervals (95% CIs) were estimated.
RESULTS
Two trials were included, overall enrolling 1550 patients. A total of 408 participants were randomized to placebo, 314 to atogepant 10 mg, 411 to atogepant 30 mg, and 417 to atogepant 60 mg once daily. The mean age of the patients was 41.0 years and 87.7% were women. The reduction in the mean number of migraine days from baseline across the 12-week treatment period was significantly greater among patients treated with atogepant at either the daily dose of 10 mg (MD - 1.16, 95% CI - 1.60 to - 0.73, p < 0.001), 30 mg (MD - 1.15, 95% CI - 1.54 to - 0.76, p < 0.001), or 60 mg (MD - 1.20, 95% CI - 2.18 to - 0.22, p = 0.016) than with placebo. There were no differences in the occurrence of AEs and drug withdrawal due to AEs between atogepant and placebo groups. Constipation was more commonly observed in patients treated with atogepant at 30 mg/day than placebo (RR 5.19, 95% CI 2.00-13.46; p = 0.001). Treatment with atogepant at the daily dose of 60 mg was associated with a higher risk of constipation (RR 4.92, 95% CI 1.89-12.79; p = 0.001) and nausea (RR 2.73, 95% CI 1.47-5.06; p = 0.001) than placebo.
CONCLUSION
Atogepant is an efficacious and overall well-tolerated treatment for the prevention of episodic migraine in adults.
引言
降钙素基因相关肽（CGRP）通路的抑制已引起偏头痛药物研究的关注。阿托格潘是一种强效、选择性、口服有效的CGRP受体拮抗剂，已被批准用于发作性偏头痛的预防性治疗。本系统评价及荟萃分析旨在评估阿托格潘预防成年患者发作性偏头痛的疗效和安全性。
方法
通过系统文献检索（2021年12月第4周）确定随机、安慰剂对照、单盲或双盲试验。主要结局包括每月偏头痛天数相对于基线的变化、不良事件（AE）的发生率以及因AE导致的治疗停药情况。估计了95%置信区间（95%CI）的平均差（MD）和风险比（RR）。
结果
纳入两项试验，共纳入1550例患者。共有408名参与者被随机分配至安慰剂组，314名至10毫克阿托格潘组，411名至30毫克阿托格潘组，417名至60毫克阿托格潘组，均为每日一次。患者的平均年龄为41.0岁，87.7%为女性。在12周治疗期内，接受10毫克/日（MD -1.16，95%CI -1.60至-0.73，p<0.001）、30毫克/日（MD -1.15，95%CI -1.54至-0.76，p<0.001）或60毫克/日（MD -1.20，95%CI -2.18至-0.22，p = 0.016）阿托格潘治疗的患者，其偏头痛天数较基线的平均减少幅度显著大于安慰剂组。阿托格潘组和安慰剂组在AE的发生及因AE导致的药物停药方面无差异。与安慰剂相比，接受30毫克/日阿托格潘治疗的患者便秘更为常见（RR 5.19，95%CI 2.00 - 13.46；p = 0.001）。与安慰剂相比，60毫克/日阿托格潘治疗与更高的便秘风险（RR 4.92，95%CI 1.89 - 12.79；p = 0.001）和恶心风险（RR 2.73，95%CI 1.47 - 5.06；p = 0.001）相关。
结论
阿托格潘是预防成人发作性偏头痛的一种有效且总体耐受性良好的治疗方法。
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