Lasmiditan for the acute treatment of migraine: Subgroup analyses by prior response to triptans

Abstract

Background Lasmiditan demonstrated superiority to placebo in the acute treatment of migraine in adults with moderate/severe migraine disability in two similarly designed Phase 3 trials, SAMURAI and SPARTAN. Post-hoc integrated analyses evaluated the efficacy of lasmiditan in patients who reported a good or insufficient response to triptans and in those who were triptan naïve. Methods Subgroups of patients reporting an overall response of “good” or “poor/none” to the most recent use of a triptan at baseline (defined as good or insufficient responders, respectively) and a triptan-naïve subpopulation were derived from combined study participants randomized to receive lasmiditan 50 mg (SPARTAN only), 100 mg or 200 mg, or placebo, as the first dose. Outcomes including headache pain-freedom, most bothersome symptom-freedom, and headache pain relief 2 hours post-first dose of lasmiditan were compared with placebo. Treatment-by-subgroup analyses additionally investigated whether therapeutic benefit varied according to prior triptan response (good or insufficient). Results Regardless of triptan response, lasmiditan showed higher efficacy than placebo (most comparisons were statistically significant). Treatment-by-subgroup analyses found that the benefit over placebo of lasmiditan did not vary significantly between patients with a good response and those with an insufficient response to triptans. Lasmiditan also showed higher efficacy than placebo in triptan-naïve patients. Conclusions Lasmiditan demonstrated comparable efficacy in patients who reported a good or insufficient response to prior triptan use. Lasmiditan also showed efficacy in those who were triptan naïve. Lasmiditan may be a useful therapeutic option for patients with migraine. Trial Registration SAMURAI (NCT02439320); SPARTAN (NCT02605174).

Evaluation of 2‐Hour Post‐Dose Efficacy of Lasmiditan for the Acute Treatment of Difficult‐to‐Treat Migraine Attacks

“…These findings suggest that the efficacy of lasmiditan is generally consistent across many patient subgroups, indicating that lasmiditan may be beneficial in treating migraine headaches in a wide range of patients or attack characteristics. These data extend previous findings that the efficacy of lasmiditan was not compromised in patients who had an insufficient response to triptans, were currently using migraine preventive medications, or had the presence of cardiovascular risk factors/comorbidities 33‐35 …”

Evaluation of Patients with Insufficient Efficacy and/or Tolerability to Triptans for the Acute Treatment of Migraine: A Systematic Literature Review

“…The statement recommends that these patients would be eligible for one of the new acute treatments, namely lasmiditan, ubrogepant, rimegepant, or neuromodulation device [1]. A recently published article not identified in this SLR, provides the response rates for lasmiditan versus placebo in patients who reported good and insufficient response to prior triptan therapy; efficacy was similar across these patient categories [60]. It may become clinically relevant to understand whether response rates of new treatments would be different in people with contraindications to triptans who immediately initiate new novel treatments versus those who have two prior triptan failures.…”

Short-term efficacy and safety of lasmiditan, a novel 5-HT1F receptor agonist, for the acute treatment of migraine: a systematic review and meta-analysis

“…Compared to previous studies [27,28] aimed to summarize the evidence on lasmiditan for the acute treatment of migraine, this study provided a systematic and more detailed assessment on the efficacy and safety of lasmiditan. Indeed, this first meta-analysis covered a greater number of studies and larger sample size to obtain more precise estimates on the efficacy and safety.…”