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Lasmiditan in migraine patients with CV risk factors

Conference
EAN 2019
Trial
Phase 3, SAMURAI and SPARTAN
Oral lasmiditan could provide an effective acute migraine treatment for patients with cardiovascular risk factors. This was concluded from the safety and efficacy results of lasmiditan in the phase 3 SAMURAI and SPARTAN trials in patients with cardiovascular risk factors [1]. Lasmiditan did not affect the risk of cardiovascular treatment-emergent adverse events.

Migraine is an independent risk factor for cardiovascular disease and is associated with an increased risk of cardiovascular events. Lasmiditan is a centrally-penetrant, serotonin 5-hydroxytryptamine receptor 1F (5-HT1F) receptor agonist which differs structurally and mechanistically from other treatments of acute migraine and lacks vasoconstrictive effects. To analyse the safety and efficacy of lasmiditan in patients with cardiovascular risk factors, data were used from SAMURAI and SPARTAN, two similarly designed randomised, double-blind, placebo-controlled trials treating a single migraine attack in adults with lasmiditan 50 mg, 100 mg, or 200 mg. Both studies included patients with cardiovascular risk factors; SPARTAN did not exclude patients with coronary artery disease, clinically significant arrhythmia, or uncontrolled hypertension.

At baseline, nearly 80% of patients had at least 1 cardiovascular risk factor; more than 40% had 2 or more cardiovascular risk factors. In SAMURAI as well as SPARTAN, significantly more patients in the lasmiditan groups were free of headache and the most bothersome associated symptoms vs placebo. The presence of cardiovascular risk factors did not impact on the efficacy results: there was no statistical difference in lasmiditan efficacy or the frequency of likely cardiovascular treatment-emergent adverse events. The only likely cardiovascular treatment-emergent adverse event seen across patients who had at least 1 cardiovascular risk factor, was palpitations.


    1. Hochstetler H, et al. EAN 2019, O2205.

 



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