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Safety and Efficacy of Ubrogepant for the Acute Treatment of Episodic Migraine: A Meta-Analysis of Randomized Clinical Trials

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Abstract

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.

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Author information

Author notes

  1. Yanbo Yang and Mingjia Chen equally contributed to this paper.

Authors and Affiliations

  1. Department of Neurosurgery & Brain and Nerve Research Laboratory, The First Affiliated Hospital of Soochow University, 188 Shizi Street, Suzhou, Jiangsu Province, 215006, China

    Yanbo Yang, Bixi Gao, Zhouqing Chen & Zhong Wang

  2. First Clinical Medical School of Soochow University, Suzhou, Jiangsu Province, 215006, China

    Yanbo Yang & Mingjia Chen

  3. School of Biology and Basic Medical Science of Soochow University, Suzhou, Jiangsu Province, 215006, China

    Yue Sun

Authors
  1. Yanbo Yang
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  2. Mingjia Chen
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  3. Yue Sun
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  4. Bixi Gao
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  5. Zhouqing Chen
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Contributions

YY was the major contributor regarding the design of the study, statistical analysis, and writing of the first draft of the manuscript. ZC was responsible for revising the manuscript, proofreading the collected data, and validating the included studies. Other authors contribute to data collection, plotting, and editing analysis tables and graphs. ZW conceived the study and was in charge of overall direction and planning.

Corresponding author

Correspondence to Zhong Wang.

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Funding

This work was supported by the Suzhou Health Talents Training Project (GSWS2019002).

Conflict of Interest

The authors, Yanbo Yang, Mingjia Chen, Yue Sun, Bixi Gao, Zhouqing Chen, and Zhong Wang, declare no competing interests.

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Yang, Y., Chen, M., Sun, Y. et al. Safety and Efficacy of Ubrogepant for the Acute Treatment of Episodic Migraine: A Meta-Analysis of Randomized Clinical Trials. CNS Drugs 34, 463–471 (2020). https://doi.org/10.1007/s40263-020-00715-7

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