Matches in SemOpenAlex for { <https://semopenalex.org/work/W3048582409> ?p ?o ?g. }
- W3048582409 endingPage "1806" @default.
- W3048582409 startingPage "1791" @default.
- W3048582409 abstract "Objective Determine whether common migraine comorbidities affect the efficacy and safety of lasmiditan, a 5-HT1F receptor agonist approved in the United States for the acute treatment of migraine.Methods In SPARTAN and SAMURAI (double-blind Phase 3 clinical trials), patients with migraine were randomized to oral lasmiditan 50 mg (SPARTAN only), 100mg, 200 mg, or placebo. Lasmiditan increased the proportion of pain-free and most bothersome symptom (MBS)-free patients at 2 h after dose compared with placebo. Most common treatment-emergent adverse events (TEAEs) were dizziness, paraesthesia, somnolence, fatigue, nausea, muscular weakness, and hypoesthesia. Based upon literature review of common migraine comorbidities, Anxiety, Allergy, Bronchial, Cardiac, Depression, Fatigue, Gastrointestinal, Hormonal, Musculoskeletal/Pain, Neurological, Obesity, Sleep, and Vascular Comorbidity Groups were created. Using pooled results, efficacy 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 also examined. Trial registration at clinicaltrials.gov: SAMURAI (NCT02439320) and SPARTAN (NCT02605174).Results Across all the Comorbidity Groups, with the potential exception of fatigue, treatment-by-subgroup interaction analyses did not provide evidence of a lasmiditan-driven lasmiditan versus placebo differential treatment effect dependent on Yes versus No comorbidity subgroup for either efficacy or TEAE assessments.Conclusions The efficacy and safety of lasmiditan for treatment of individual migraine attacks appear to be independent of comorbid conditions." @default.
- W3048582409 created "2020-08-18" @default.
- W3048582409 creator A5012905064 @default.
- W3048582409 creator A5036999043 @default.
- W3048582409 creator A5081661447 @default.
- W3048582409 creator A5088641256 @default.
- W3048582409 date "2020-10-06" @default.
- W3048582409 modified "2023-09-30" @default.
- W3048582409 title "Lasmiditan in patients with common migraine comorbidities: a <i>post hoc</i> efficacy and safety analysis of two phase 3 randomized clinical trials" @default.
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