The use of lasmiditan for the treatment of migraine may be associated with a dose-dependent incidence of mild to moderate dizziness, according to a study published in Headache.
This post hoc analysis of 2 double-blind trials (SAMURAI: Clinicaltrials.gov identifier: NCT02439320 and SPARTAN: Clinicaltrials.gov identifier: NCT02605174) was conducted to determine the prevalence of dizziness associated with the use of lasmiditan for the acute treatment of migraine. A total of 4439 participants with a history of migraine were randomly assigned to receive oral lasmiditan (50 mg, n=654; 100 mg, n=1265; 200 mg, n=1258) or placebo (n=1262) within 4 hours of migraine onset. Baseline demographics were similar between groups.
Dizziness occurred in 2.9% of participants taking placebo and in 8.6%, 14.9%, and 16.8% of patients receiving lasmiditan at 50 mg, 100 mg, and 200 mg, respectively, with severe dizziness occurring in 0.1%, 0.3%, 0.7%, and 1.4% of participants, respectively. Most patients who reported dizziness rated the severity as mild or moderate. Dizziness had a median onset of 30 to 40 minutes after medication intake and had a median duration of 1.5 to 2 hours. Vertigo was reported by 21 patients (placebo, <0.1%; lasmiditan 50 mg, 0.3%; lasmiditan 100mg, 0.9%; lasmiditan 200 mg, 0.6%).
Risk factors for dizziness in participants who received lasmiditan as their first dose were a higher lasmiditan dose, being non-Hispanic/Latino, having mild or moderate migraine intensity, and having lower body mass index. The incidence of dizziness did not affect daily activity, patients’ global impression of change, freedom from pain, or the most bothersome symptom 2 hours after dosing.
Study limitations include that experiences such as lightheadedness, vertigo, and wooziness were all grouped under dizziness.
“[D]izziness with lasmiditan was more common with higher doses, of rapid onset and short duration, and generally mild to moderate,” concluded the study authors. “[A]n open-label extension of SAMURAI and SPARTAN is under way and will provide additional understanding of lasmiditan-associated dizziness with repeated doses.”
Tepper SJ, Krege JH, Lombard L, et al. Characterization of dizziness after lasmiditan: findings from the SAMURAI and SPARTAN acute migraine treatment randomized trials [published online June 1, 2019]. Headache. doi:10.1111/head.13544