Background

Ubrogepant is a small molecular calcitonin gene–related peptide receptor antagonist that is used for the acute treatment of migraine.

Objective

The aim was to conduct a meta-analysis to systematically evaluate the efficacy and safety of ubrogepant for the treatment of episodic migraine compared with placebo in the adult population.

Methods

We systematically searched PubMed, EMBASE, and the Cochrane Library Central Register of Controlled Trials for relevant randomized clinical trials, from the earliest available date to November 10, 2019, to evaluate the efficacy and safety of short-term ubrogepant use. Inclusion criteria were (1) randomized clinical trial; (2) enrolled adult participants diagnosed with episodic migraine; (3) compared ubrogepant with placebo at doses that were evaluated in phase III clinical trials; (4) enrolled more than 100 patients in each group; and (5) provided any information on primary or secondary outcomes. Trials were excluded if their participants were diagnosed with chronic migraine.

Results

A total of three multicenter, randomized clinical trials with 3326 patients were included. Ubrogepant use was associated with a significantly higher percentage of patients with pain freedom (ubrogepant 20.8%; placebo 12.6%; relative risk [RR] 1.65, 95% confidence interval [CI] 1.38–1.98) and absence of the most bothersome migraine-associated symptoms (ubrogepant 37.3%; placebo 27.6%; RR 1.35, 95% CI 1.20–1.53) at 2 h post-dose compared with placebo. Ubrogepant increased the rate of absence of migraine-associated symptoms at 2 h post-dose compared with placebo (photophobia: RR 1.30 [95% CI 1.18–1.44], I² = 49%; phonophobia: RR 1.20 [95% CI 1.11–1.29]; nausea: RR 1.07 [95% CI 1.02–1.13]), and patients were more likely to function normally at 2 h post-dose compared with placebo (RR 1.30 [95% CI 1.16–1.45]). No significant difference was found for treatment-related adverse events within 48 h or 30 days for ubrogepant compared with placebo (48 h: RR 1.07 [95% CI 0.85–1.35]; 30 days: RR 1.03 [95% CI 0.79–1.34]). Subgroup analysis demonstrated that compared to placebo, ubrogepant led to greater rates of freedom from pain at 2 h with 25-mg, 50-mg, and 100-mg doses and absence of the most bothersome symptoms with 50-mg and 100-mg doses.

Conclusions

The use of ubrogepant as an acute treatment of episodic migraine in adults led to a greater percentage of freedom from pain and absence of the most bothersome symptoms at 2 h post-dose. Short-term use of ubrogepant was not related to an increased risk for adverse events. Further studies are needed to evaluate efficacy and safety for long-term use and in specific subgroups of patients.

中文翻译：

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Ubrogepant 急性发作性偏头痛的安全性和有效性：随机临床试验的荟萃分析。

背景

Ubrogepant 是一种小分子降钙素基因相关肽受体拮抗剂，用于偏头痛的急性治疗。

客观的

目的是进行荟萃分析，以系统地评估 ubrogepant 在成人人群中与安慰剂相比治疗发作性偏头痛的有效性和安全性。

方法

我们系统地检索了 PubMed、EMBASE 和 Cochrane 图书馆中央对照试验登记库中的相关随机临床试验，从最早可用日期到 2019 年 11 月 10 日，以评估短期使用 ubrogepant 的有效性和安全性。纳入标准为（1）随机临床试验；(2) 被诊断患有发作性偏头痛的成年参与者；(3) 在 III 期临床试验中评估的剂量下比较 ubrogepant 与安慰剂；(4)每组入组100名以上患者；(5) 提供有关主要或次要结果的任何信息。如果参与者被诊断出患有慢性偏头痛，则试验被排除在外。

结果

共纳入三项多中心、随机临床试验，共 3326 名患者。Ubrogepant 的使用与显着更高比例的无痛患者相关（ubrogepant 20.8%；安慰剂 12.6%；相对风险 [RR] 1.65，95% 置信区间 [CI] 1.38–1.98）并且没有最令人烦恼的偏头痛相关与安慰剂相比，给药后 2 小时的症状（ubrogepant 37.3%；安慰剂 27.6%；RR 1.35，95% CI 1.20–1.53）。与安慰剂相比，Ubrogepant 增加了给药后 2 小时偏头痛相关症状的消失率（畏光：RR 1.30 [95% CI 1.18–1.44]，I ²= 49%；声音恐惧症：RR 1.20 [95% CI 1.11–1.29]；恶心：RR 1.07 [95% CI 1.02-1.13]），与安慰剂相比，患者在给药后 2 小时更有可能正常运作（RR 1.30 [95% CI 1.16-1.45]）。与安慰剂相比，ubrogepant 在 48 小时或 30 天内的治疗相关不良事件没有发现显着差异（48 小时：RR 1.07 [95% CI 0.85–1.35]；30 天：RR 1.03 [95% CI 0.79–1.34] ）。亚组分析表明，与安慰剂相比，ubrogepant 使用 25-mg、50-mg 和 100-mg 剂量导致更高的 2 小时无疼痛率，并且使用 50-mg 和 100-mg 剂量没有最烦人的症状.

结论

使用 ubrogepant 作为成人发作性偏头痛的急性治疗方法，在给药后 2 小时内无疼痛和最烦人的症状消失的比例更高。ubrogepant 的短期使用与不良事件风险的增加无关。需要进一步的研究来评估长期使用和特定患者亚组的有效性和安全性。