Abstract
BackgroundMigraine has been recognized as one of common diseases in the world whose current treatment options are not ideal. Lasmiditan, an oral 5-hydroxytryptamine (HT)1F receptor agonist, appears more promising for the acute treatment of migraine because of considerably better effect profiles with no severe adverse events (AEs). This review aimed to systematically evaluate the efficacy and safety of lasmiditan from the results of randomized controlled trials (RCTs).MethodsPubMed, Cochrane Library, Embase were searched on lasmiditan for the acute treatment of migraine from inception of the databases to Feb 1, 2020. Pain free and pain relief, global impression (very much/much better), and no/mild disability at 2 h in efficacy; total treatment-emergent adverse events (TEAEs), dizziness, nausea, fatigue, paraesthesia and somnolence in safety were extracted from the included studies. A systematic review and meta-analysis was performed using Review Manager Software version 5.3 (RevMan 5.3).ResultsFour RCTs with a total of 4960 subjects met our inclusion criteria. The overall effect estimate showed that lasmiditan was significantly superior to placebo in terms of pain free (RR 1.71, 95% CI 1.55–1.87), pain relief (RR 1.40, 95% CI 1.33–1.47), global impression (very much/much better) (RR 1.55, 95% CI 1.44–1.67), and no/mild disability (RR 1.15, 95% CI 1.10–1.20) at 2 h. For the safety, significant number of patients experienced TEAEs with lasmiditan than with placebo (RR 2.77, 95% CI 2.53–3.03), most TEAEs were central nervous system (CNS)-related and included dizziness (RR 5.81, 95% CI 4.72–7.14), nausea (RR 2.58, 95% CI 1.87–3.57), fatigue (RR 5.38, 95% CI 3.78–7.66), paraesthesia (RR 4.48, 95% CI 3.33–6.02), and somnolence (RR 2.82, 95% CI 2.18–3.66).ConclusionsThis meta-analysis suggests that lasmiditan is effective for the acute treatment of migraine with a higher incidence of CNS-related adverse reactions compared with placebo. Long-term, open-label, multi-dose trials are required to verify the current findings.
Highlights
Migraine has been recognized as one of common diseases in the world whose current treatment options are not ideal
The articles were included in the meta-analysis if they met the following criteria: (1) included patients were adults (18–65 years of age) with migraine with or without aura which had been diagnosed according to the International Headache Society criteria (IHS) [10, 11]; (2) randomized controlled trials (RCTs) evaluating the efficacy and safety of lasmiditan for the acute treatment of migraine; (3) lasmiditan and placebo in any formulation or in any dose as treatment group and control group respectively; (4) relevant indexes of the efficacy and safety of lasmiditan were provided or could be calculated from original data in the articles
A total of 4 RCTs involved in phase II – III (4960 participants) met the inclusion criteria and were included in this review [16–19]
Summary
Migraine has been recognized as one of common diseases in the world whose current treatment options are not ideal. Lasmiditan, an oral 5-hydroxytryptamine (HT)1F receptor agonist, appears more promising for the acute treatment of migraine because of considerably better effect profiles with no severe adverse events (AEs). 45.1 million of total years lived with disability are suffered from migraine [1], which has a significant impact on quality of life and increased use of health resources [2, 3]. It is characterized by moderate-severe, unilateral, throbbing headache attacks lasting from 4 to 72 h, accompanied by additional symptoms such as nausea, vomiting, phonophobia, and/or photophobia [4]. The triptans, regarded as the gold standard in the migraine therapy, are a class of selective and effective 5hydroxytryptamine (HT)1B/1D receptor agonists that have replaced ergot derivatives. A new acute therapy for migraine is urgently needed, especially for those patients unable to achieve optimal outcomes with current therapies
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