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Randomized Controlled Trial
. 2022 May;38(5):721-730.
doi: 10.1080/03007995.2022.2057152. Epub 2022 Apr 3.

Migraine history and response to lasmiditan across racial and ethnic groups

Larry Charleston 4th  1 , Belinda Savage-Edwards  2 , Sonja M Bragg  3 , Simin K Baygani  3 , Ellen B Dennehy  3   4
Affiliations
Free article
Randomized Controlled Trial

Migraine history and response to lasmiditan across racial and ethnic groups

Larry Charleston 4th et al. Curr Med Res Opin. 2022 May.
Free article

Abstract

Objective: The robust enrollment in SPARTAN and SAMURAI provided the opportunity to present post-hoc descriptive details on migraine disease characteristics and treatment outcomes after treatment with lasmiditan, a selective serotonin (5-HT1F) receptor agonist, in racial and ethnic subgroups.

Methods: Descriptive data from racial (White [W](n = 3471) and Black or African American [AA](n = 792)) and ethnic (Hispanic or Latinx [HL](n = 775) and Non-Hispanic or Latinx [Non-HL](n = 3637)) populations are presented on pooled data from two double-blind, placebo-controlled, randomized Phase 3 studies (SAMURAI [NCT02439320] and SPARTAN [NCT2605174]). Patients were treated with lasmiditan (50 (SPARTAN only), 100, or 200 mg) or placebo for a single migraine attack of moderate-to-severe intensity. Efficacy data were recorded in an electronic diary at baseline, 30, 60, 90, and 120 min. Safety was evaluated and reported by occurrences of adverse events.

Results: Clinical characteristics were generally similar across populations. W participants had longer migraine history than AA participants, and Non-HL participants had more migraine disability than HL participants. In the lasmiditan single-attack studies, AA participants waited longer than W participants to take study drug. A higher proportion of HL participants rated baseline migraine severity as severe compared to Non-HL participants. Response to lasmiditan was similar across racial and ethnic groups, including pain response, freedom from most bothersome symptom and migraine-related disability, and safety and tolerability. Across multiple outcomes, AA and HL participants tended to report more positive outcomes.

Conclusions: There were few differences in demographic and clinical characteristics across racial and ethnic groups. Similar lasmiditan efficacy and safety outcomes were observed in AA versus W participants, and in HL versus Non-HL participants. Small observed differences may be driven by a tendency toward a more positive response observed across all treatment groups by AA and HL participants.

Trial registration: ClinicalTrials.gov NCT02439320 NCT02605174.

Keywords: Migraine attack; clinical trials; ethnic; lasmiditan; racial.

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