The tolerability of lasmiditan, a selective serotonin (5-HT) 1F receptor agonist, was evaluated in elderly and non-elderly patients in a pooled analysis of two Phase 3 studies of lasmiditan in the acute treatment of migraine.

This post-hoc analysis of pooled data evaluated treatment-emergent adverse events (TEAEs), defined as adverse events occurring within 48 hours of the first dose (regardless of whether a second dose was taken), in elderly (aged ≥65 years) versus non-elderly (<65 years) lasmiditan-treated patients. Treatment-by-age subgroup interactions were examined using logistic regression analysis.

The analysis included 3,177 lasmiditan-treated patients, of whom 132 (4.2%) were elderly, and 1,262 placebo-treated patients, of whom 54 (4.3%) were elderly. The percentage of patients with at least 1 TEAE was similar for elderly (34.8%) and non-elderly (35.7%) lasmiditan-treated patients. No significant treatment-by-age subgroup interactions were seen in patients who reported at least 1 TEAE overall or for any individual TEAE. There were some numerical differences in the incidences of individual TEAEs between elderly and non-elderly patients treated with lasmiditan (Elderly/non-elderly patients: Dizziness, 18.9%/14.5%; paresthesia, 7.6%/5.6%; nausea, 3.0%/3.4%; hypoesthesia, 2.3%/1.2%; vertigo, 2.3%/0.5%; somnolence, 2.3%/5.6%; fatigue, 2.3%/3.8%; restlessness, 1.5%/0.3%; visual impairment, 1.5%/0.2%; muscle weakness, 0.8%/1.3%; asthenia: 0.8%/1.1%, vomiting: 0.8%/1.0%). However, no trend was identified nor any safety signals observed in the elderly age group.

In a pooled analysis of two Phase 3 studies, the overall incidence of TEAEs with lasmiditan was similar for elderly and non-elderly patients with migraine. However, numerical differences in the incidence of some specific TEAEs were seen.