Shigekazu Kitamura,1 Noboru Imai,2 Yuka Tanji,3 Akichika Ozeki,3 Mika Komori3 1Department of Neurology, Konan Kakogawa Hospital, Hyogo, Japan; 2Department of Neurology, Japanese Red Cross Shizuoka Hospital, Shizuoka, Japan; 3Japan Drug Development and Medical Affairs, Eli Lilly Japan K.K., Kobe, JapanCorrespondence: Mika Komori, Japan Drug Development and Medical Affairs, Eli Lilly Japan K.K., 5-1-28, Isogamidori, Chuo-Ku, Kobe-Shi, 651-0086, Japan, Tel +81-78-242-8391, Fax +81-78-242-9939, Email komori_mika@lilly.comBackground: Migraine is often comorbid with other disorders. People with migraine may be prescribed one or more concomitant medications. This post hoc analysis assessed the safety and efficacy of lasmiditan in Japanese people with migraine comorbidities or using concomitant medications.Patients and Methods: The MONONOFU study was a Phase 2, randomized, placebo-controlled, multicenter study of lasmiditan for acute migraine treatment in Japanese adults. Patients reported comorbidities (pre-existing or coexisting conditions) during screening. Concomitant medications (any drugs taken ± 48 hours of the study drug) and treatment-emergent adverse events (TEAEs) were recorded in a paper diary. Study drug efficacy (pain freedom 2 hours after administration of study drug) was reported in an eDiary. Logistic regression models were used for subgroup analyses of safety (incidence of TEAEs) and efficacy (pain freedom at 2 hours post dose) of lasmiditan in relation to presence/absence of comorbidities, and safety in relation to concomitant medications.Results: Common comorbidities (occurring in ≥ 10% of any lasmiditan dose group) were seasonal allergies, allergic rhinitis, tension-type headache, cervicobrachial syndrome, dysmenorrhea, nasopharyngitis, musculoskeletal stiffness, chronic gastritis, constipation, and insomnia. There was no significant interaction of treatment with comorbidity for safety or efficacy. There was also no significant interaction between treatment and concomitant medication groups of special interest (acetaminophen/nonsteroidal anti-inflammatory drugs, triptans, antiemetics, central nervous system depressant medications, serotonergic medications, antiepileptics, antihypertensive medications, Chinese herbal medicines, and contraceptives) for incidence of TEAEs.Conclusion: In Japanese people with migraine, the safety of lasmiditan appeared to be independent of common comorbidities and concomitant medications; efficacy appeared to be independent of comorbid conditions.Clinical Trials Registration: NCT03962738 (ClinicalTrials.gov).Keywords: comorbidity, drug therapy, headache, Japan, migraine disorders, safety
