Age does not factor in tolerability, safety of lasmiditan for migraine
The tolerability and safety of lasmiditan for the acute treatment of migraine attacks in older patients are consistent with those observed in younger patients, according to a post-hoc analyses of previous studies.
The analyses included the phase III trials SAMURAI*, SPARTAN**, and the open-label GLADIATOR++ involving adults who took placebo vs lasmiditan 50 (SPARTAN only), 100, or 200 mg for a single migraine attack within 4 hours of the onset of moderate or severe pain. Patients who completed SAMURAI or SPARTAN were eligible to enrol in GLADIATOR.
Pooled data from SAMURAI or SPARTAN showed that 132 of 3,177 patients (4.2 percent) treated with lasmiditan and 54 of 1,262 patients (4.3 percent) given placebo were elderly (≥65 years of age). Meanwhile, 85 of 2,030 lasmiditan-treated patients (4.2 percent) in GLADIATOR were elderly.
The incidences of at least one treatment-emergent adverse events (TEAEs) with lasmiditan in elderly and younger patients were 35 percent and 36 percent in pooled SAMURAI+SPARTAN, respectively, and 38 percent and 49 percent in GLADIATOR.
There was no significant treatment-by-age subgroup interactions observed in patients with ≥1 TEAE overall or for any individual TEAE in pooled SPARTAN+SAMURAI. Likewise, there appeared to be no treatment-by-age subgroup interactions and no tolerability concerns for individual TEAEs detected.
Cardiovascular TEAEs occurred with much greater frequency among the younger population than the elderly population. Specifically, there were no cardiovascular events reported in the elderly population during the treatment-emergent period or intermediate period. There were, however, two cases of increased blood pressure in elderly patients during the remote period.
* A Study of Two Doses of LAsMiditan (100 mg and 200 mg) Compared to Placebo in the AcUte Treatment of MigRAIne
** A Study of Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute TReaTment of MigrAiNe
++ An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine