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A post hoc analysis was conducted to assess if the common migraine comorbidities impact the safety and efficacy of lasmiditan (a 5-hydroxytryptamine/serotonin receptor 1F [5-HT1F ] receptor agonist), approved in the United States for the acute management of patients with migraine.
As found in a post hoc analysis, the safety and
efficacy of lasmiditan for treating individual attacks of migraine were
independent of the comorbid conditions.
A post hoc analysis was
conducted to assess if the common migraine comorbidities impact the safety and
efficacy of lasmiditan (a 5-hydroxytryptamine/serotonin
receptor 1F [5-HT1F ] receptor
agonist), approved
in the United States for the acute management of patients with migraine.
In double-blind Phase III (SPARTAN and SAMURAI) clinical trials, migraine patients were randomly allocated to orally administered 50 mg lasmiditan (SPARTAN only), 100 mg, 200 mg, or placebo. Considering the literature review of common migraine comorbidities, the following comorbidity groups were created: Anxiety, bronchial, allergy, cardiac, fatigue, depression, hormonal, gastrointestinal, musculoskeletal/pain, obesity, neurological, vascular, and sleep.
The treatment-emergent adverse events (TEAEs) and efficacy were evaluated utilizing pooled results to compare individuals with or without common migraine comorbidity. To compare the therapeutic groups, the p-values were measured for treatment-by-subgroup interaction. This was done based on logistic regression with treatment-by-comorbidity condition status (Yes versus No) defined as the interaction term. Study, comorbidity condition status (Yes versus No), treatment group were defined as the covariates. Based on the comorbidity status, the differential treatment effect was also examined.
No relevant proof of a lasmiditan-driven lasmiditan compared to placebo differential treatment impact based on Yes versus No comorbidity subgroup was noted for TEAEs and efficacy evaluations in the treatment-by-subgroup interaction analyses. This was noted for all the comorbidity groups (except fatigue).
There is a requisition of further studies to validate these post hoc,
exploratory findings. This is because the low number of patients in the “Yes”
Subgroup for several Comorbidity Groups could have adversely impacted the
current assessments as well as because of other limitations inherent in the
exploratory analyses.
For managing patients suffering from migraine attacks, the safety
and efficacy of lasmiditan were found to be independent of comorbid conditions.
Current Medical Research and Opinion
Lasmiditan in patients with common migraine comorbidities: a post hoc efficacy and safety analysis of two Phase 3 randomized clinical trials
David B. Clemow et al.
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