Real-World Safety and Effectiveness of Lasmiditan in Patients with Migraine: A Post-Marketing Observational Study in Japan

INTRODUCTION: receptor agonist approved for acute migraine treatment, provides an alternative for patients who cannot tolerate or do not respond to existing therapies, including triptans. The study aimed to evaluate the real-world safety and effectiveness of lasmiditan in Japanese patients with migraine as part of post-marketing pharmacovigilance requirements. METHODS: This single-arm, multicenter, non-interventional, prospective observational study enrolled 550 patients from 53 medical sites across Japan. Patients newly prescribed lasmiditan for acute migraine between June 2022 and September 2024 were included. Data were collected via electronic case report forms, eDiaries, and questionnaires. Safety assessments included adverse events (AEs), serious AEs (SAEs), and treatment-emergent AEs (TEAEs). Effectiveness was evaluated by pain freedom and pain relief at 2 h post-dose. Data were summarized using descriptive statistics. RESULTS: Of the 400 patients analyzed for safety (mean age 40.5 years; 79.5% female), 56.0% received 50 mg and 42.8% received 100 mg lasmiditan as the initial dose. About 41.8% experienced at least one TEAE, with no SAEs or deaths. The most common TEAEs were dizziness (8.4%) and somnolence (3.9%) with a median time to resolution of 3 and 4 h, respectively. In the effectiveness analysis set (n = 328), for moderate-to-severe headache, 21.5% and 53.9% achieved pain freedom or pain relief, respectively, 2 h post-first dose. For specific daily activities, 45.9% of work or school tasks improved from "severely disturbed" and "couldn't move" to "no problem" or "slightly disturbed" after 2 h. CONCLUSIONS: Lasmiditan was associated with a manageable safety profile and effectiveness in patients with acute migraine in routine clinical practice in Japan, with no new safety concerns identified.