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瑞美吉泮用于偏头痛急性治疗的真实世界开放标签经验:一项多中心试点研究。

Real-World Open-Label Experience with Rimegepant for the Acute Treatment of Migraine Attacks: A Multicenter Pilot Study.

作者信息

Dermitzakis Emmanouil V, Rikos Dimitrios, Vikelis Michail, Xiromerisiou Georgia, Zisopoulou Styliani, Rallis Dimitrios, Soldatos Panagiotis, Vlachos George S, Vasiliadis Georgios G, Argyriou Andreas A

机构信息

Euromedica General Clinic, 54645 Thessaloniki, Greece.

404 Military Hospital, 41222 Larisa, Greece.

出版信息

Brain Sci. 2024 Nov 22;14(12):1169. doi: 10.3390/brainsci14121169.

Abstract

The present open-label multicenter pilot study sought to prospectively evaluate the efficacy and safety of rimegepant in treating migraine attacks. The primary endpoint was pain freedom at two hours post-dose, while the co-primary efficacy endpoints included a reduction in the headache intensity and freedom from the most bothersome symptoms (MBS) associated with migraine at the same time point. To test the potential efficacy of rimegepant, patients were asked to record in a questionnaire all the relevant changes with each migraine attack treated with rimegepant at two hours post-dose vs. two hours before. The attending neurologists provided information on the basic demographics, medical anamnesis, and migraine history as well as the triptan use history. A total of 54 patients (32 with episodic and 22 with chronic migraine) received rimegepant 75 mg at least once during a single migraine attack (overall, 140 dosage intakes). Pain freedom at 2 h was achieved in 45/140 (32.1%) intakes. Regarding the efficacy of the first rimegepant dose (n = 54), significant reductions in the headache intensity were observed between the pre- and 2 h post-treatment average VAS scores (-4.8 ± 2.8 mean; < 0.001). Likewise, the same mean reductions in the average VAS scores occurred when the 2 h response to all 140 doses was analyzed (-5 ± 2.8; < 0.001). Freedom from MBS at 2 h post-dose was achieved for photophobia in 43%, for phonophobia in 53%, and for nausea in 57%. The ability to fully return to everyday activities at 2 h post-dose was achieved in 83/140 instances (59%). We only recorded mild adverse events in 24/140 dosages. Our preliminary results demonstrate that rimegepant is effective, safe, and well tolerated in treating acute migraine attacks.

摘要

本开放标签多中心试点研究旨在前瞻性评估瑞美吉泮治疗偏头痛发作的疗效和安全性。主要终点是给药后两小时的无痛状态,而共同主要疗效终点包括在同一时间点头痛强度的降低以及摆脱与偏头痛相关的最困扰症状(MBS)。为了测试瑞美吉泮的潜在疗效,要求患者在问卷中记录每次用瑞美吉泮治疗的偏头痛发作在给药后两小时与给药前两小时的所有相关变化。主治神经科医生提供了基本人口统计学、病史和偏头痛病史以及曲坦类药物使用史等信息。共有54例患者(32例发作性偏头痛和22例慢性偏头痛)在单次偏头痛发作期间至少服用一次75 mg瑞美吉泮(总计140次剂量摄入)。在140次剂量摄入中有45次(32.1%)在2小时时达到无痛状态。关于首次瑞美吉泮剂量(n = 54)的疗效,治疗前和治疗后2小时的平均视觉模拟评分(VAS)之间观察到头痛强度显著降低(平均-4.8±2.8;<0.001)。同样,分析所有140次剂量在2小时时的反应时,平均VAS评分也出现了相同程度的降低(-5±2.8;<0.001)。给药后2小时,畏光症状的MBS摆脱率为43%,畏声症状为53%,恶心症状为57%。在140次情况中有83次(59%)在给药后2小时能够完全恢复日常活动。我们仅在140次剂量中有24次记录到轻度不良事件。我们的初步结果表明,瑞美吉泮在治疗急性偏头痛发作方面有效、安全且耐受性良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8309/11674050/6f878cbe7b65/brainsci-14-01169-g001.jpg

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