拉科酰胺对发作性偏头痛患者降钙素基因相关肽血清水平的影响：一项随机对照试验。

The effect of lacosamide on calcitonin gene-related peptide serum level in episodic migraine patients: a randomized, controlled trial.

机构信息

Neurology Department, Faculty of Medicine, Kafr El-Sheikh University, Elgeish Street, Kafr El-Sheikh, Egypt.

Clinical Pathology Department, Faculty of Medicine, Mansoura University, Al Korneish Street, Mansoura, Egypt.

出版信息

Acta Neurol Belg. 2024 Jun;124(3):965-972. doi: 10.1007/s13760-024-02499-9. Epub 2024 Mar 19.

DOI:10.1007/s13760-024-02499-9

PMID:38502425

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11139685/

Abstract

BACKGROUND

Migraine affects 11-15% of people worldwide, and the calcitonin gene-related peptide (CGRP) is released during the migraine attack, producing pulsating pain of migraine. Also, lacosamide reacts with collapsin-response mediator protein 2, preventing its phosphorylation and leading to the inhibition of CGRP release in the trigeminal system.

OBJECTIVE

The primary outcome was the difference in the serum level of CGRP-LI after three months of treatment with either lacosamide and ibuprofen or ibuprofen alone in episodic migraine patients. The secondary outcomes were assessing safety and efficacy of lacosamide in episodic migraine patients.

METHODS

We conducted an open-label randomized controlled trial on episodic migraine patients aged 10-55 years diagnosed according to (ICHD-3) in Kafr El-Sheikh University Hospital, Egypt. We assessed serum levels of CGRP-LI before and three months after treatment in our two groups, the lacosamide, and the control groups. We also assessed the side effects of treatment in each group, the percentage of patients who achieved ≥ 50% reduction in the migraine monthly days (MMD) frequency and the percentage of patients who achieved pain freedom within 2 h in ≥ 4 of 5 attacks in each group.

RESULTS

200 episodic migraine patients completed the study. There was a statistically significantly higher reduction in the serum CGRP-LI level in the lacosamide group compared with the control group. In addition, lacosamide was well tolerated by patients. Also, the lacosamide group had statistically significant higher percentage of patients who achieved ≥ 50% reduction in the migraine monthly days (MMD) frequency and pain freedom within two hours in ≥ 4 of 5 attacks with P-values 0.002, 0.02 respectively.

CONCLUSION

The daily use of lacosamide 50 mg Bid for three months in episodic migraine patients was associated with a significant reduction in serum CGRP-LI, better clinical outcomes regarding frequency and duration of migraine attacks, and was well tolerated by patients. These results were derived from an open-label pilot study that needed to be thoroughly investigated by a large-scale, randomized, double-blinded, placebo-controlled study.

TRIAL REGISTRATION

We registered our trial on ClinicalTrials.gov, named after "The Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients," and with a clinical trial number (NCT05632133)-August 8, 2023.

摘要

背景

偏头痛影响全球 11-15%的人口，降钙素基因相关肽 (CGRP) 在偏头痛发作期间释放，导致偏头痛的搏动性疼痛。此外，拉考酰胺与 collapsin 反应介体蛋白 2 反应，阻止其磷酸化，从而抑制三叉神经系统中 CGRP 的释放。

目的

主要结局是在发作性偏头痛患者中，用拉考酰胺和布洛芬或布洛芬单独治疗三个月后血清 CGRP-LI 水平的差异。次要结局是评估拉考酰胺在发作性偏头痛患者中的安全性和疗效。

方法

我们在埃及卡夫尔·谢赫大学医院对根据 (ICHD-3) 诊断的 10-55 岁发作性偏头痛患者进行了一项开放标签随机对照试验。我们在我们的两组（拉考酰胺组和对照组）中评估了治疗前和治疗后三个月的血清 CGRP-LI 水平。我们还评估了每组治疗的副作用，偏头痛每月天数 (MMD) 频率减少≥50%的患者百分比以及每组≥5 次攻击中≥4 次在 2 小时内疼痛缓解的患者百分比。

结果

200 例发作性偏头痛患者完成了研究。与对照组相比，拉考酰胺组血清 CGRP-LI 水平降低有统计学意义。此外，拉考酰胺患者耐受性良好。此外，拉考酰胺组在偏头痛每月天数 (MMD) 频率减少≥50%和≥5 次攻击中≥4 次在 2 小时内疼痛缓解的患者百分比方面具有统计学意义更高（P 值分别为 0.002、0.02）。