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Abstract Details

Lasmiditan in Patients with Common Migraine Comorbidities: A Post hoc, Safety, and Efficacy Analysis of Two Phase 3 Randomized Clinical Trials
Headache
P6 - Poster Session 6 (12:00 PM-1:00 PM)
7-009

Lasmiditan is a 5-HT1F receptor agonist being developed as an acute treatment for migraine. SAMURAI and SPARTAN were double-blind Phase 3 clinical trials of patients with migraine, randomized to oral lasmiditan 50 (SPARTAN only), 100, 200 mg, or placebo. Lasmiditan increased the proportion of pain-free and most bothersome symptom (MBS)-free patients at 2 hours after dose compared with placebo. Most common treatment-emergent adverse events (TEAEs) were dizziness, paresthesia, somnolence, fatigue, nausea, muscular weakness, and hypoesthesia.

 

To determine whether common comorbidities affect the efficacy and safety of lasmiditan.

Results from SPARTAN and SAMURAI were pooled for this post hoc study. Based upon literature review of common migraine comorbidities, anxiety, allergy, bronchial, cardiac, depression, fatigue, gastrointestinal, hormonal, musculoskeletal and pain, neurological, obesity, sleep, and vascular groups were created. Subsequently, 2-hr pain freedom, 2-hr MBS freedom, and TEAEs were assessed to compare patients with or without a given common migraine comorbidity. To compare treatment groups, p-values were calculated for treatment-by-subgroup interaction, based on logistic regression with treatment-by-Comorbidity Condition Status (Yes/No) as the interaction term; study, treatment group, and Comorbidity Condition Status (Yes/No) were covariates.  Differential treatment effect based upon comorbidity status was examined.

 

Across all the comorbidity groups, with a few exceptions, the treatment-by-subgroup interaction did not provide evidence of a differential treatment effect (LTN vs PBO) dependent on subgroup (comorbidity ‘yes’ vs comorbidity ‘no’) for the efficacy and TEAE assessments.

 

The efficacy and safety of lasmiditan for treatment of single migraine attacks appear to be independent of comorbid conditions.

Authors/Disclosures
David Clemow
PRESENTER
No disclosure on file
Simin Baygani Simin Baygani has received personal compensation for serving as an employee of Eil Lilly & Company. Simin Baygani has received stock or an ownership interest from Eli Lilly & Company.
Paula M. Hauck Paula M Hauck has received personal compensation for serving as an employee of Eli Lilly and Company.
Cory Hultman No disclosure on file
Raghavendra Vasudeva, PhD Dr. Vasudeva has received personal compensation for serving as an employee of Lilly. Dr. Vasudeva has received stock or an ownership interest from Lilly.