Abstract
BackgroundMigraine is recognized as the second leading cause of disability globally. Lasmiditan is a novel, selective serotonin 5-HT1F receptor agonist developed for acute treatment of migraine. Here we analyzed effects of lasmiditan on migraine disability assessed with the Migraine Disability Assessment (MIDAS) scale for interim data from a long-term safety study.MethodsCompleters of two single-attack parent studies were offered participation in the 1 year GLADIATOR study, that randomized participants to treatment with lasmiditan 100 mg or 200 mg taken as needed for migraine attacks of at least moderate severity. Changes in MIDAS were modeled using a mixed model repeated measures analysis.ResultsThe sample included 1978 patients who received ≥1 lasmiditan dose and were followed for a median of 288 days. Baseline mean MIDAS scores for the lasmiditan 100-mg and 200-mg groups were 29.4 and 28.9, respectively, indicating severe migraine-related disability. Relative to baseline, MIDAS total scores were significantly lower at 3, 6, 9, and 12 months for both dose groups. At 12 months, changes in MIDAS scores were − 12.5 and − 12.2 for lasmiditan 100 mg and 200 mg, respectively, with 49% and 53% of patients, respectively, achieving at least a 50% decrease in MIDAS total score. Statistically significant improvements were also seen for work and/or school absenteeism and presenteeism, monthly headache days, and mean headache pain intensity at all time points up to 1 year. Findings for patients who completed all visits versus those dropping out early were similar. Responses were generally similar for the lasmiditan 100 mg or 200 mg doses, between subgroups defined based on the number of baseline monthly migraine attacks (≤5 vs. >5), and also between subgroups defined by pain-free response (yes/no) during initial attacks.ConclusionsLong-term treatment with lasmiditan was associated with significant reductions in migraine-related disability, including both work or school absenteeism and presenteeism. The similarity of responses in completers and those who dropped out suggests that selective attrition does not account for the improvements. Benefits were significant at 3 months and maintained through 12 months.Trial registrationclinicaltrials.govNCT02565186; first posted October 1, 2015.
Highlights
Migraine is recognized as the second leading cause of disability globally
Migraine-related disability The mean Migraine Disability Assessment (MIDAS) total score at baseline was approximately 29, which is in the range of severe migraine
Migraine imposes a significant burden on family, work, school, and social life, especially to those under age 55. [3, 5] The MIDAS is a valid and reliable migrainerelated disability measure that is strongly correlated with clinical judgement of the severity of migraine and the need for healthcare services [22]
Summary
Lasmiditan is a novel, selective serotonin 5-HT1F receptor agonist developed for acute treatment of migraine. Lasmiditan is an oral, selective 5-HT1F receptor agonist indicated for the acute treatment of migraine. The studies were designed, double-blind, and placebo-controlled, with participants randomized to treat a single migraine attack with oral lasmiditan (50 mg [SPARTAN only], 100 mg, or 200 mg) or placebo. In both of those studies, all doses of lasmiditan were significantly more effective than placebo based on the primary endpoint, pain freedom at 2 h postdose, and the key secondary endpoint, freedom from the patient-designated most bothersome symptom at 2 h postdose. Lasmiditan was generally safe and well tolerated, with no deaths and few serious adverse events reported [13]
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