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Galcanezumab in migraine prevention: a systematic review and meta-analysis of randomized controlled trials.
Therapeutic Advances in Neurological Disorders ( IF 5.9 ) Pub Date : 2020-04-28 , DOI: 10.1177/1756286420918088 Panagiotis Gklinos 1 , Dimos D Mitsikostas 2
Therapeutic Advances in Neurological Disorders ( IF 5.9 ) Pub Date : 2020-04-28 , DOI: 10.1177/1756286420918088 Panagiotis Gklinos 1 , Dimos D Mitsikostas 2
Affiliation
Background
Galcanezumab, along with three other monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway, represents the latest disease-specific and mechanism-based treatment for the prophylaxis of migraine. Galcanezumab shares data also for the prophylaxis of cluster headache.
Objective
To provide a pooled safety and efficacy analysis of all phase III randomized controlled trials of galcanezumab in the preventive therapy of migraine.
Methods
A computer-based literature search was conducted on MEDLINE and the US National Institutes of Health Clinical Trials Registry for phase III randomized controlled trials of galcanezumab in migraine prevention. The primary outcome was the mean change in monthly migraine days (MMDs). The proportions of patients who reported at least one adverse event (AE), at least one serious adverse event (SAE) or withdrew from the study were used as safety outcomes.
Results
Two trials were included in the efficacy meta-analysis and three in the safety meta-analysis. Migraine preventive treatment with subcutaneous galcanezumab, at both 120 mg and 240 mg dosages, was associated with a significantly greater reduction in the mean number of MMDs versus placebo (120 mg, MD = -1.98, 95% CI = -2.33 to -1.63; p < 0.0001) or (240 mg, MD = -1.86, 95% CI = -2.20 to -1.53; p < 0.0001). Galcanezumab was found to be more efficacious in all key secondary outcomes as well. Regarding safety, most of the adverse events were mild to moderate, while drop-out rates and serious adverse events were low.
Conclusions
Galcanezumab is an efficacious and well-tolerated preventive treatment for migraine. Larger clinical trials with longer follow-up periods need to be conducted in order to provide more safety data of the above-mentioned drug.
中文翻译:
Galcanezumab 预防偏头痛:随机对照试验的系统评价和荟萃分析。
背景 Galcanezumab 以及其他三种靶向降钙素基因相关肽 (CGRP) 途径的单克隆抗体代表了用于预防偏头痛的最新疾病特异性和基于机制的治疗方法。Galcanezumab 还共享用于预防丛集性头痛的数据。目的 对所有 galcanezumab 用于预防偏头痛的 III 期随机对照试验的安全性和有效性进行汇总分析。方法 在 MEDLINE 和美国国立卫生研究院临床试验注册中心进行基于计算机的文献检索,以获取 galcanezumab 预防偏头痛的 III 期随机对照试验。主要结果是每月偏头痛天数 (MMD) 的平均变化。报告至少一种不良事件(AE)的患者比例,至少一项严重不良事件 (SAE) 或退出研究被用作安全性结果。结果 两项试验纳入疗效荟萃分析,三项纳入安全性荟萃分析。与安慰剂相比,使用 120 mg 和 240 mg 剂量的皮下 galcanezumab 进行偏头痛预防性治疗与 MMD 的平均数量显着减少相关(120 mg,MD = -1.98,95% CI = -2.33 至 -1.63; p < 0.0001) 或 (240 mg, MD = -1.86, 95% CI = -2.20 至 -1.53;p < 0.0001)。发现 Galcanezumab 在所有关键的次要结果中也更有效。在安全性方面,大多数不良事件为轻度至中度,而辍学率和严重不良事件较低。结论 Galcanezumab 是一种有效且耐受性良好的偏头痛预防性治疗方法。
更新日期:2020-04-28
中文翻译:
Galcanezumab 预防偏头痛:随机对照试验的系统评价和荟萃分析。
背景 Galcanezumab 以及其他三种靶向降钙素基因相关肽 (CGRP) 途径的单克隆抗体代表了用于预防偏头痛的最新疾病特异性和基于机制的治疗方法。Galcanezumab 还共享用于预防丛集性头痛的数据。目的 对所有 galcanezumab 用于预防偏头痛的 III 期随机对照试验的安全性和有效性进行汇总分析。方法 在 MEDLINE 和美国国立卫生研究院临床试验注册中心进行基于计算机的文献检索,以获取 galcanezumab 预防偏头痛的 III 期随机对照试验。主要结果是每月偏头痛天数 (MMD) 的平均变化。报告至少一种不良事件(AE)的患者比例,至少一项严重不良事件 (SAE) 或退出研究被用作安全性结果。结果 两项试验纳入疗效荟萃分析,三项纳入安全性荟萃分析。与安慰剂相比,使用 120 mg 和 240 mg 剂量的皮下 galcanezumab 进行偏头痛预防性治疗与 MMD 的平均数量显着减少相关(120 mg,MD = -1.98,95% CI = -2.33 至 -1.63; p < 0.0001) 或 (240 mg, MD = -1.86, 95% CI = -2.20 至 -1.53;p < 0.0001)。发现 Galcanezumab 在所有关键的次要结果中也更有效。在安全性方面,大多数不良事件为轻度至中度,而辍学率和严重不良事件较低。结论 Galcanezumab 是一种有效且耐受性良好的偏头痛预防性治疗方法。