Migraine: safety and efficacy of lasmiditan

  • Goadsby PJ & al.
  • Brain
  • 27 May 2019

  • curated by Sarfaroj Khan
  • UK Clinical Digest
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Takeaway

  • Lasmiditan (50, 100 and 200 mg) at 2-hour post-dose was effective and relatively well tolerated in the acute treatment of a single migraine attack.

Why this matters

  • These findings support the efficacy of lasmiditan for the treatment of acute migraine and hypothesis that 5-HT1F receptor activation can relieve the pain and symptoms associated with a migraine attack, although the relative contribution of central vs peripheral action cannot be determined from these findings.

Study design

  • 2156 patients with migraine were randomly assigned to receive lasmiditan (200 mg, n=528; 100 mg, n=532; 50 mg, n=556) and placebo (n=540).
  • Primary outcome: proportion of patients achieving headache pain-free and most bothersome symptom (MBS)-free at 2 hours post-dose for each dose of lasmiditan vs placebo.
  • Funding: Eli Lilly and Company.

Key results

  • The proportion of patients who were pain-free at 2 hours was significantly higher in lasmiditan 200 mg (OR, 2.3; 95% CI, 1.8-3.1), 100 mg (OR, 1.7; 95% CI, 1.3-2.2; P<.001 and mg ci p=".003)" groups vs placebo group.>
  • Higher proportion of patients in lasmiditan 200 mg (OR, 1.9; 95% CI, 1.4-2.4), 100 mg (OR, 1.6; 95% CI, 1.2-2.0; P<.001 and mg ci p=".009)" groups were mbs-free at hours vs placebo group.>
  • The proportion of patients who reported ≤1 treatment-emergent adverse events (TEAEs) were higher in lasmiditan 200 mg (39.0%), 100 mg (36.1%) and 50 mg (25.4%) groups vs placebo group (11.6%).
  • Dizziness, somnolence, and paraesthesia were the most frequently reported TEAEs in lasmiditan (all doses) and placebo group.

Limitations

  • Study has limited generalisability.
  • Findings were limited to primarily a single dose.