Tolerability and Safety of Lasmiditan Treatment in Elderly Patients With Migraine: Post Hoc Analyses From Randomized Studies

Purpose: Limited information is available on acute treatments for migraine in elderly patients. Our objective was to evaluate the tolerability and safety of lasmiditan, a serotonin 1F agonist, treatment compared with nonelderly patients, special emphasis cardiovascular-related issues because cardiovascular comorbidities are more common population.Methods: These post hoc analyses evaluated incidence treatment-emergent adverse events (TEAEs) (≥65 years age) versus (<65 lasmiditan-treated Two clinical trials entitled A Study Doses LAsMiditan (100 mg 200 mg) Compared Placebo AcUte Treatment MigRAIne (SAMURAI) Three Lasmiditan (50 mg, 100 Acute TReaTment MigrAiNe (SPARTAN) were randomized, double-blind, placebo-controlled, Phase III studies adults (no upper age limit) who took placebo or lasmiditan 50 (SPARTAN only), 100, single attack within 4 hours onset moderate severe pain. Patients completed SAMURAI SPARTAN eligible enroll An Open-label, LonG-term, Safety LAsmiDItan Of MigRaine (GLADIATOR), III, open-label, multiattack study mg. For pooled SAMURAI+SPARTAN data, × subgroup interactions examined using logistic regression analyses. In addition, event rates assessed from GLADIATOR during 3 periods: (<48 after dosing), intermediate (48 1 week remote (>1 dosing).Findings: 3177 patients SPARTAN, 132 (4.2%) elderly, 1262 placebo-treated 54 (4.3%) elderly. 2030 GLADIATOR, 85 The incidences at least TEAE 36% 35% SAMURAI+SPARTAN, respectively, 49% 38% respectively. No significant observed ≥1 overall any individual SPARTAN+SAMURAI; however, numerical differences some specific TEAEs seen. no concerns detected. Cardiovascular much frequent population than population. not reported period period. There 2 cases increased blood pressure period.Implications: similar generally consistent that single-attack studies. signals limited number ClinicalTrials.gov identifiers: NCT02565186 NCT02439320 (SAMURAI), NCT02605174 (SPARTAN).