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Abstract Details

Tolerability of Lasmiditan in Elderly Patients with Migraine
Headache
Headache Posters (7:00 AM-5:00 PM)
045
SAMURAI (NCT02439320) and SPARTAN (NCT02605174) were randomized, double-blind, controlled studies of adults (no upper age limit) who received placebo or lasmiditan 50, 100 or 200mg for a single migraine attack, within 4h of the onset of moderate or severe pain.

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.

Authors/Disclosures
Zubair Ahmed, MD (Apex Medical Research )
PRESENTER
Dr. Ahmed has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Ahmed has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Ahmed has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biohaven.
Vincent Martin No disclosure on file
Andrew Buchanan No disclosure on file
Simin Baygani Simin Baygani has received personal compensation for serving as an employee of Eil Lilly & Company. Simin Baygani has received stock or an ownership interest from Eli Lilly & Company.
Helen Hochstetler, PharmD (Lilly USA) Helen Hochstetler, PharmD has received personal compensation for serving as an employee of Eli Lilly and Company. Helen Hochstetler, PharmD has received stock or an ownership interest from Eli Lilly and Company.
Rashna Khanna Rashna Khanna has nothing to disclose.
Emel Serap Nery (Eli Lilly and Company) Emel Serap Nery has received personal compensation for serving as an employee of Eli Lilly and Company.