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Lasmiditan for Acute Treatment of Migraine in Adults: A Systematic Review and Meta-analysis of Randomized Controlled Trials

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Abstract

Background

The US Food and Drug Administration has approved orally administered 100-mg and 200-mg doses of lasmiditan for the acute treatment of migraine, with or without aura. Having a unique mechanism of action, lasmiditan is the first and only Food and Drug Administration-approved serotonin 5-HT1F receptor agonist.

Objective

The objective of this study was to systematically evaluate the efficacy and safety of lasmiditan for the acute treatment of migraine in adult patients.

Methods

We systematically searched PUBMED, EMBASE, and Cochrane Library databases. Any relevant articles published before 3 March, 2020 were collected. Inclusion criteria were: (1) randomized clinical trials; (2) enrolled adult participants diagnosed with migraine; (3) compared lasmiditan at 100 mg or 200 mg with placebo; (4) enrolled more than 100 participants; and (5) provided any available data for predefined primary or secondary outcomes.

Results

Three high-quality, multi-centered randomized clinical trials with 4506 patients in total were included. We found that the use of lasmiditan was related to a significantly increased rate of pain freedom at 2 h post-dose with 31.60% patients achieving freedom of pain in the lasmiditan group compared with 17.55% patients in the placebo group (relative risk [RR] 1.80 [95% confidence interval (CI) 1.34–2.42]), with no significant heterogeneity. In addition, lasmiditan is reported to significantly increase the rate of absence of the most bothersome symptoms at 2 h compared with the placebo group with no significant heterogeneity (lasmiditan, 42.82%; placebo, 30.38%; RR 1.44 [95% CI 1.03–2.01], I2 = 0%). With regard to the safety endpoints, compared with the placebo group, participants in the lasmiditan group had a higher rate of fatigue, paresthesia, and somnolence (fatigue: lasmiditan, 1.94%; placebo, 0.24%; RR 7.96 [95% CI 0.4–158.86]; paresthesia: lasmiditan, 6.91%; placebo, 1.56%; RR 4.46 [95% CI 1.54–12.93], somnolence: lasmiditan, 5.9%; placebo, 2.15%; RR 2.76 [95% CI, 1.49–5.11]) with low heterogeneity. A subgroup analysis demonstrated that without safety differences, participants who received the 200-mg dose had a higher percentage of freedom of pain at 2 h and sustained pain relief at 2–24 h compared with the 100-mg dose (freedom of pain at 2 h: lasmiditan, 34.53%; placebo, 28.67%; RR 1.2 [95% CI 1.04–1.38]; lasmiditan, 20.62%; placebo, 16.33%; RR 1.26 [95% CI 1.19–1.34]), with low heterogeneity for both outcomes (I2 = 0%).

Conclusions

In this meta-analysis, the use of lasmiditan as an acute treatment for episodic migraine in adults led to a greater percentage of freedom of pain and the absence of the most bothersome symptoms at 2 h post-dose. Lasmiditan 200 mg had superior efficacy to 100-mg dose without a significantly increased risk for adverse events.

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Authors and Affiliations

Authors

Contributions

YY was the main contributor to the design, statistical analysis, and writing of the first manuscript. YS was responsible for revising the manuscript, checking the collected data, and validating the included studies. Data collection, plotting, and editing analysis tables and graphs were allocated to other authors. ZC constructed the study and was in charge of overall direction and planning.

Corresponding author

Correspondence to Zhouqing Chen.

Ethics declarations

Funding

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

Conflict of interest

Yanbo Yang, Yue Sun, Bixi Gao, Zilan Wang, Zhouqing Chen, and Zhong Wang have no conflicts of interest that are directly relevant to the content of this article.

Ethics approval

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Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplement 1 Full electronic search strategy (DOC 16 kb)

Supplement 2 Baseline characteristics of each comparison (DOC 32 kb)

40263_2020_753_MOESM3_ESM.docx

Supplement 3 Forest plots of all efficacy and safety endpoints, lasmiditan vs placebo and lasmiditan 200 mg vs lasmiditan 100 mg. CI confidence interval, RR relative risk (DOCX 1711 kb)

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Yang, Y., Sun, Y., Gao, B. et al. Lasmiditan for Acute Treatment of Migraine in Adults: A Systematic Review and Meta-analysis of Randomized Controlled Trials. CNS Drugs 34, 1015–1024 (2020). https://doi.org/10.1007/s40263-020-00753-1

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