Lasmiditan abortive therapy for episodic migraine in Phase II/III randomized clinical trials: A meta-analysis.

Abstract

Although migraine is common, there are very few treatment options. Recently, lasmiditan, a specific 5-HT1F agonist, has gained approval as abortive therapy for migraine. This meta-analysis and trial sequential analysis (TSA) was performed to analyze efficacy and tolerability of lasmiditan therapy for episodic migraine. Phase II and Phase III double-blinded placebo-controlled randomized controlled trials (RCTs) evaluating lasmiditan for episodic migraine were searched for from electronic databases. The risk of bias was estimated, data were extracted, and relative risk (RR) were calculated for efficacy and safety outcomes with a fixed/random effect model. Forest plots and funnel plots were created. TSA graph was plotted. Therapeutic gain with lasmiditan was calculated. Six high-quality RCTs were included with 7122 patients. Compared to placebo, lasmiditan demonstrated a significant proportion of migraineurs reporting freedom from headache, most bothersome symptom, headache response, no disability, global impression "very much/much better" 2 h posttreatment and sustained pain freedom at 24 and 48 h with 50, 100, 200, and 400 mg doses (RR range = 1.26-2.50). 39.3% of patients in the lasmiditan group (RR = 2.43) reported one or more treatment-emergent adverse event (TEAE). Dizziness, somnolence, paresthesia, fatigue, nausea, vertigo, hypoesthesia, asthenia, muscular weakness, lethargy, and malaise had a high incidence (RR range = 3.16-12.77). Most TEAEs were mild to moderate. No vasoconstriction-related TEAE was reported. Lasmiditan demonstrated efficacy as abortive therapy for episodic migraine with central nervous system-related side effects.