Unmet Acute Treatment Needs From the 2017 Migraine in America Symptoms and Treatment Study

Lipton, Richard B.; Munjal, Sagar; Buse, Dawn C.; Alam, Aftab; Fanning, Kristina M.; Reed, Michael L.; Schwedt, Todd J.; Dodick, David W.

doi:10.1111/head.13588

Cited by 65 publications

(70 citation statements)

References 44 publications

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“…Efficacy was evaluated for subgroups based on a specific patient, migraine disease, and attack characteristics that have been historically associated with reduced efficacy of acute treatment (“difficult‐to‐treat”). Analyses included the following subgroups of patients: ≥24 headache days in past 3 months, history of migraine ≥20 years, severe disability based on MIDAS score ≥21, 31 obesity 4,18 (BMI ≥30 kg/m 2 ), history of psychiatric disorder (depression, bipolar disorder, anxiety, sleep disorders, and/or post‐traumatic stress disorder), 4,31 rapidly escalating attack (headache progressed to moderate‐to‐severe headache intensity within 60 minutes from pain onset), 32 severe headache at the time of treatment, 32 co‐existence of nausea at the time of treatment, delayed treatment 31,32 (patients who initiated treatment at >2 and ≥4 hours post‐onset of attack), and patients with patient‐reported migraine‐related functional disability defined as “needs complete bed rest” at the time of treatment 5,31 …”

Section: Methodsmentioning

confidence: 99%

Evaluation of 2‐Hour Post‐Dose Efficacy of Lasmiditan for the Acute Treatment of Difficult‐to‐Treat Migraine Attacks

et al. 2020

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Objective To identify factors predicting response (2‐hour headache pain freedom or most bothersome symptom freedom) to lasmiditan based on individual patient characteristics, migraine disease characteristics, and migraine attack characteristics. Further, efficacy specifically in difficult‐to‐treat patient/migraine disease characteristics or attack characteristics (ie, historically considered less responsive to certain acute therapies) subgroups was analyzed. Background Knowledge of factors associated with a positive or negative response to acute treatment would be useful to practitioners prescribing acute treatments for migraine. Additionally, practitioners and patients would benefit from understanding the efficacy of lasmiditan specifically in subgroups of patients with migraine disease characteristics and migraine attack characteristics historically associated with decreased pain threshold, reduced efficacy of acute treatment, or increased burden of migraine. Methods Pooled analyses were completed from 2 Phase 3 double‐blind clinical trials, SPARTAN and SAMURAI. Data from baseline to 2 hours after taking lasmiditan (50, 100, or 200 mg) or placebo were analyzed to assess efficacy based on patient characteristics, migraine disease characteristics, and migraine attack characteristics. A total of 3981 patients comprising the intent‐to‐treat population were treated with placebo (N = 1130), lasmiditan 50 mg (N = 598), lasmiditan 100 mg (N = 1133), or lasmiditan 200 mg (N = 1120). Data were analyzed for the following efficacy measures at 2 hours: headache pain freedom and most bothersome symptom freedom. Results None of the analyzed subgroups based on individual patient characteristics, migraine disease characteristics, or migraine attack characteristics predicted headache pain freedom or most bothersome symptom freedom response at 2 hours following lasmiditan treatment (interaction P ≥ .1). For the difficult‐to‐treat patient/migraine disease characteristics subgroups (defined as those with ≥24 headache days in the past 3 months, duration of migraine history ≥20 years, severe disability [Migraine Disability Assessment score ≥21], obesity [≥30 kg/m2], and history of psychiatric disorder), single doses of lasmiditan (100 or 200 mg) were significantly more effective than placebo (P ≤ .002) in achieving both endpoints. Headache pain freedom response rates for higher doses of lasmiditan were numerically greater than for lower doses of lasmiditan. For the difficult‐to‐treat migraine attack subgroups, patients with severe headache, co‐existent nausea at the time of treatment, or who delayed treatment for ≥2 hours from the time of headache onset, both endpoint response rates after lasmiditan 100 or 200 mg were significantly greater than after placebo. Among those who delayed treatment for ≥4 hours from the time of headache onset, headache pain freedom response rates for the 200 mg dose of lasmiditan met statistical significance vs placebo (32.4% vs 15.9%; odds ratio = 2.7 [1.17, 6.07]; P = .018). While the predictors of respo...

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Section: Methodsmentioning

confidence: 99%

Evaluation of 2‐Hour Post‐Dose Efficacy of Lasmiditan for the Acute Treatment of Difficult‐to‐Treat Migraine Attacks

et al. 2020

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“…Many people with migraine have treatment management gaps, including high levels of migraine‐associated disability and dissatisfaction with the efficacy and/or tolerability of their current acute treatment regimen . Currently available medications for the acute treatment of migraine attacks may be ineffective or poorly tolerated in some patients and are contraindicated in people with certain cardiovascular comorbidities .…”

Section: Introductionmentioning

confidence: 99%

“…Currently available medications for the acute treatment of migraine attacks may be ineffective or poorly tolerated in some patients and are contraindicated in people with certain cardiovascular comorbidities . The recently conducted 2017 Migraine in America Symptoms and Treatment Study demonstrated that 95.8% of respondents with migraine (inclusion criteria: at least 3 monthly headache days in the past 3 months and at least 1 headache day in the past 30 days) who were currently taking an oral acute prescription medication for headache had at least 1 unmet need; the most common attack‐related unmet needs were rapid onset (65.3%) and disability (55.6%) . New migraine‐specific acute medications that reduce headache‐related disability may provide more treatment options with increased satisfaction for people with migraine.…”

Section: Introductionmentioning

confidence: 99%

“…13 Many people with migraine have treatment management gaps, including high levels of migraineassociated disability and dissatisfaction with the efficacy and/or tolerability of their current acute treatment regimen. 14,15 Currently available medications for the acute treatment of migraine attacks may be ineffective or poorly tolerated in some patients and are contraindicated in people with certain cardiovascular comorbidities. 14,[16][17][18] The recently conducted 2017 Migraine in America Symptoms and Treatment Study demonstrated that 95.8% of respondents with migraine (inclusion criteria: at least 3 monthly headache days in the past 3 months and at least 1 headache day in the past 30 days) who were currently taking an oral acute prescription medication for headache had at least 1 unmet need; the most common attack-related unmet needs were rapid onset (65.3%) and disability (55.6%).…”

Section: Introductionmentioning

confidence: 99%

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Ubrogepant, an Acute Treatment for Migraine, Improved Patient‐Reported Functional Disability and Satisfaction in 2 Single‐Attack Phase 3 Randomized Trials, ACHIEVE I and II

et al. 2020

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Objective To evaluate the efficacy of ubrogepant on patient‐reported functional disability, satisfaction with study medication, and global impression of change. Background Ubrogepant is a small‐molecule, oral calcitonin gene‐related peptide receptor antagonist indicated for the acute treatment of migraine. In 2 phase 3 trials (ACHIEVE I and II), ubrogepant demonstrated efficacy vs placebo on the 2 co‐primary endpoints of headache pain freedom and absence of the most bothersome migraine‐associated symptom at 2 hours post dose for the 50 and 100 mg doses. Patient‐reported outcomes, such as functional disability, satisfaction, and patient global impression of change, can provide additional evidence of the efficacy of an acute treatment for migraine on clinically meaningful and patient‐relevant outcomes. Methods ACHIEVE I and ACHIEVE II were multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, single‐attack trials in adults (18‐75 years) with migraine. In ACHIEVE I, participants were randomized 1:1:1 to placebo or ubrogepant 50 or 100 mg; in ACHIEVE II, participants were randomized 1:1:1 to placebo or ubrogepant 25 or 50 mg to treat a migraine attack with moderate or severe headache pain. Participants rated ability to perform daily activities on the Functional Disability Scale, before dosing and at 1, 2, 4, and 8 hours after the initial dose; satisfaction with study medication at 2 and 24 hours; and impression of overall change in migraine on the Patient Global Impression of Change scale at 2 hours. In prespecified analyses for each trial, each outcome was compared between each ubrogepant dose group and the relevant placebo group. Data were pooled from the ubrogepant 50 mg and placebo groups of the 2 trials in a post hoc analysis. Results In ACHIEVE I, 559 participants were randomized to placebo, 556 to ubrogepant 50 mg, and 557 to ubrogepant 100 mg; in ACHIEVE II, 563 were randomized to placebo, 561 to ubrogepant 25 mg, and 562 to ubrogepant 50 mg. At 2 hours post dose, significantly higher proportions of ubrogepant‐treated participants vs placebo‐treated participants reported being able to function normally (ACHIEVE I: ubrogepant 50 mg, 40.6% [171/421], P = .0012 vs placebo; ubrogepant 100 mg, 42.9% [192/448], P < .0001 vs placebo; placebo, 29.8% [136/456]; ACHIEVE II: ubrogepant 25 mg, 42.6% [185/434], P = .0015 vs placebo; ubrogepant 50 mg, 40.5% [188/464], P = .0118 vs placebo; placebo, 34.2% [156/456]; pooled 50 mg, 40.6% [359/885], vs pooled placebo, 32.0% [292/912]; P < .0001), were satisfied/extremely satisfied with study medication (ACHIEVE I: 50 mg, 36.3% [147/405], P < .0001 vs placebo; 100 mg, 35.8% [149/416], P = .0002 vs placebo; placebo, 24.1% [104/432]; ACHIEVE II: 25 mg, 35.1% [141/402], P = .0018 vs placebo; 50 mg, 37.8% [163/431], P < .0001 vs placebo; placebo, 24.8% [106/427]; pooled ubrogepant 50 mg, 37.1% [310/836], vs pooled placebo, 24.5% [210/859]; P < .0001), and indicated that their migraine was much/very much better on the Patient Global Impression of Change scale (A...

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“…Using the pain-free response at 2 hours for frovatriptan 2.5 mg as the clinical endpoint, unilateral pain, presence of phonophobia, presence of one or more cranial autonomic symptoms, and presence of one or more premonitory symptom were each associated with that outcome. Patients and physicians want better ways to associate their treatments with outcomes and are largely unsatisfied with current prescription therapies (19,20). So far, some studies have identified migraine features associated with (poor) triptan efficacy (7,8).…”

Section: Discussionmentioning

confidence: 99%

Predicting the response to a triptan in migraine using deep attack phenotyping: A feasibility study

Viana

Sances²,

Terrazzino

et al. 2020

Cephalalgia

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Background Triptans, specific symptomatic medications for migraine, are not effective in a proportion of patients, or in all attacks, hence the importance of identifying predictors of response. Our aim was to investigate the association between the efficacy of oral frovatriptan 2.5 mg and clinical characteristics of migraine attacks. Methods We enrolled 29 consecutive patients affected by migraine without aura at the Headache Center of “Mondino” Institute of Pavia. Each patient was given a diary and asked to record prospectively the features of three consecutive migraine attacks while using frovatriptan. A generalized estimating equations approach was used to determine phenotypic features associated with the pain free response at 2 hours. Results Participants provided complete data for 85 attacks. Thirty of these (34%) patients reported being pain free 2 hours after taking frovatriptan 2.5 mg intake. Unilateral pain, presence of phonophobia, presence of one or more cranial autonomic symptoms and presence of one or more premonitory symptom were each associated with being pain free at 2 hours. Conclusions The response to frovatriptan was associated with particular features of the migraine attack, either before or during the pain phase of attacks. The data support larger studies to explore detailed attack phenotyping, with particular attention to early signs, to enable individualized treatment in migraine.

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Unmet Acute Treatment Needs From the 2017 Migraine in America Symptoms and Treatment Study

Cited by 65 publications

References 44 publications

Evaluation of 2‐Hour Post‐Dose Efficacy of Lasmiditan for the Acute Treatment of Difficult‐to‐Treat Migraine Attacks

Evaluation of 2‐Hour Post‐Dose Efficacy of Lasmiditan for the Acute Treatment of Difficult‐to‐Treat Migraine Attacks

Ubrogepant, an Acute Treatment for Migraine, Improved Patient‐Reported Functional Disability and Satisfaction in 2 Single‐Attack Phase 3 Randomized Trials, ACHIEVE I and II

Predicting the response to a triptan in migraine using deep attack phenotyping: A feasibility study

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