Objectives To summarize the baseline methods for the Migraine in America Symptoms and Treatment (MAST) Study and evaluate gender differences in sociodemographics and headache features; consultation and diagnosis patterns; and patterns of acute and preventive treatment use for migraine among study participants. Background The MAST Study is a longitudinal, internet‐based panel study of symptoms, approaches to management, and unmet treatment needs among US adults with migraine. This analysis focuses on the initial cross‐sectional survey, conducted beginning in 2016, and is intended to update results from earlier national epidemiologic surveys of people with migraine in the United States. Methods Respondents to the MAST Study were recruited from a US nationwide online research panel. Stratified random sampling identified a representative cohort of adults (aged ≥18 years). We administered a validated diagnostic screener based on modified ICHD‐3 beta criteria to identify individuals with migraine averaging at least 1 monthly headache day (MHD) over the previous 3 months. A baseline assessment evaluated sociodemographic and headache features, patterns of consultation and diagnosis, and use of acute and preventive medications for migraine. Frequency data and chi‐square contrasts (P < .05) were used to compare respondents based on gender. Results Baseline survey data (N = 95,821) identified 18,353 respondents who met criteria for migraine, including 15,133 (women n = 11,049, men n = 4084) reporting at least 1 MHD for the preceding 3 months. The mean age of the sample was 43.1 (13.6) years; 73.0% of respondents were women, and 81.0% were Caucasian. Compared with men, women were younger (46.1 vs 42.0 years; P < .001); had more MHDs (5.6 vs 5.3; P < .001); and were more likely to report moderate or severe headache‐related disability (45.9% vs 35.8%; P < .001) and cutaneous allodynia (43.7% vs 29.5%; P < .001). The lifetime rate of medical consultation for headache was 79.8% overall and slightly higher in women than in men. Women were more likely than men to have been diagnosed with migraine (48.3% vs 38.8%, P < .001). While 95.1% of people with migraine currently used acute treatment, the majority (58.9%) used over‐the‐counter (OTC) drugs to the exclusion of prescription drugs, while 11.3% used exclusively prescription drugs, and 20.5% used both. Among acute prescription medication users, women were more likely than men to take triptans (17.7% vs 14.3%, P < .001), while men were more likely than women to take opioids (14.5% vs 9.2%, P < .001). Oral formulations were used predominately (92.7% of the medication users), but men were more likely to use nasal sprays (13.6% vs 9.4%, P < .001) and injectables (7.9% vs 3.4%, P <  .001). Men (14.5%) were also significantly more likely than women (10.4%) to be taking daily oral preventive medication (P < .001). Conclusions The MAST Study identified a large sample of women and men with migraine from a sampling frame that broadly resembles the US population. Low participation r...

Background: Migraine has many presumed comorbidities which have rarely been compared between samples with and without migraine. Examining the association between headache pain intensity and monthly headache day (MHD) frequency with migraine comorbidities is novel and adds to our understanding of migraine comorbidity. Methods: The MAST Study is a prospective, web-based survey that identified US population samples of persons with migraine (using modified International Classification of Headache Disorders-3 beta criteria) and without migraine. Eligible migraine participants averaged ≥1 MHDs over the prior 3 months. Comorbidities "confirmed by a healthcare professional diagnosis" were endorsed by respondents from a list of 21 common cardiovascular, neurologic, psychiatric, sleep, respiratory, dermatologic, pain and medical comorbidities. Multivariable binary logistic regression calculated odds ratios (OR) and 95% confidence intervals for each condition between the two groups adjusting for sociodemographics. Modeling within the migraine cohort assessed rates of conditions as a function of headache pain intensity, MHD frequency, and their combination. Results: Analyses included 15,133 people with migraine (73.0% women, 77.7% White, mean age 43 years) and 77, 453 controls (46.4% women, 76.8% White, mean age 52 years). People with migraine were significantly (P < 0.001) more likely to report insomnia (OR 3.79 [3.6, 4.0]), depression (OR 3.18 [3.0, 3.3]), anxiety (OR 3.18 [3.0 3.3]), gastric ulcers/GI bleeding (OR 3.11 [2.8, 3.5]), angina (OR 2.64 [2.4, 3.0]) and epilepsy (OR 2.33 [2.0, 2.8]), among other conditions. Increasing headache pain intensity was associated with comorbidities related to inflammation (psoriasis, allergy), psychiatric disorders (depression, anxiety) and sleep conditions (insomnia). Increasing MHD frequency was associated with increased risk for nearly all conditions and most prominent among those with comorbid gastric ulcers/GI bleeding, diabetes, anxiety, depression, insomnia, asthma and allergies/hay fever.

This study estimated the population exposure to cigarette smoke constituents in adult U.S. smokers and identified significant differences between subpopulations. The data may serve as a reference for monitoring the impact of changes in cigarette consumption and the introduction of potentially reduced exposure cigarettes.

These results provide a snapshot of the effectiveness of usual acute treatment as well as predictors of inadequate acute treatment response in a large population sample of people with episodic migraine. These results highlight the high rates of unmet treatment needs in people with migraine. Similarities and differences in predictors vary with outcome for reasons that are discussed.

BackgroundThe MAST Study is a longitudinal, cross-sectional survey study of US adults with migraine. These analyses were conducted to estimate rates of acute medication overuse (AMO) and determine associations of AMO with individual and headache characteristics.MethodsEligible respondents had ICHD-3-beta migraine, reported ≥3 monthly headache days (MHDs) in the past 3 months, ≥1 MHD in the past 30 days, and currently took acute headache medication. AMO was defined according to ICHD-3-beta thresholds for monthly days of medication taking when diagnosing medication overuse headache.ResultsEligible respondents (N = 13,649) had a mean age of 43.4 ± 13.6 years; most were female (72.9%) and Caucasian (81.9%). Altogether, 15.4% of respondents met criteria for AMO. Compared with those not overusing medications, respondents with AMO were significantly more likely to be taking triptans (31.3% vs 14.2%), opioids (23.8% vs 8.0%), barbiturates (7.8% vs 2.7%), and ergot alkaloids (3.1% vs 0.6%) and significantly less likely to be taking NSAIDs (63.3% vs 69.8%) (p < 0.001 for all comparisons). Respondents with AMO had significantly more MHDs (12.9 ± 8.6 vs 4.3 ± 4.3, p  <  0.001); higher migraine symptom severity (17.8 ± 2.7 vs 16.4 ± 3.0, p  <  0.001), higher pain intensity scores (7.4 vs 6.5, p  <  0.001); and higher rates of cutaneous allodynia (53.7% vs 37.5%, p  <  0.001). Adjusted for MHDs, the odds of AMO were increased by each additional year of age (OR 1.02, 95% CI 1.02, 1.03); being married (OR 1.19, 95% CI 1.06, 1.34); smoking (OR 1.54, 95% CI 1.31, 1.81); having psychological symptoms (OR 1.62, 95% CI 1.43, 1.83) or cutaneous allodynia (OR 1.22, 95% CI 1.08, 1.37); and greater migraine symptom severity (OR 1.06, 95% CI 1.04, 1.09) and pain intensity (OR 1.27, 95% CI 1.22, 1.32). Cutaneous allodynia increased the risk of AMO by 61% in males (OR 1.61, 95% CI 1.28, 2.03) but did not increase risk in females (OR 1.08, 95% CI 0.94, 1.25).ConclusionsAMO was present in 15% of respondents with migraine. AMO was associated with higher symptom severity scores, pain intensity, and rates of cutaneous allodynia. AMO was more likely in triptan, opioid, and barbiturate users but less likely in NSAID users. Cutaneous allodynia was associated with AMO in men but not women. This gender difference merits additional exploration.

Objectives.-The objectives of this study were to determine the rates of nausea, phonophobia, and photophobia reported overall and as the most bothersome symptom (MBS) in individuals with migraine and to identify individual characteristics associated with each of the 3 candidate MBSs.Background.-The MBS has emerged as an important coprimary efficacy endpoint in clinical trials of acute treatments for migraine, as recommended by the Food and Drug Administration. The current understanding of how persons with migraine designate an associated symptom as the most bothersome has been assessed primarily in the context of randomized trials. Methods.-Respondents (n = 95,821) in the cross-sectional, observational Migraine in America Symptoms and Treatment (MAST) study were adults (aged ≥18 years) recruited from a US nationwide online research panel. A validated diagnostic screener identified 15,133 individuals who met modified International Classification of Headache Disorders (ICHD)-3 betacriteria for migraine and reported at least 1 monthly headache day (MHD) over the previous 3 months. The survey ascertained sociodemographic variables, headache-related disability, MHDs, cutaneous allodynia, medication overuse, a migraine symptom severity score, pain interference, noncephalic pain, anxiety and depression symptoms, visual aura over the previous year, and acute treatment optimization. The current analysis is based on respondents who also completed a 6-month follow-up assessment that included questions about their most bothersome headache symptom.Results.-A total of 7518 respondents completed the 6-month follow-up, and 6045 met inclusion criteria and were included in the analysis. The mean age of respondents was 47 (SD 13.4) years, 76.0% (4596/6045) were women, and 84.8% (5103/6017) were white. Among all respondents, 64.9% reported all 3 migraine symptoms. The MBS was photophobia in 49.1% (2967/6045), nausea in 28.1% (1697/6045), and phonophobia in 22.8% (1381/6045). Respondents reporting photophobia as the MBS were more likely to be men, to be obese, and to report visual aura. Those reporting nausea as the MBS were more likely to be women, to have lower incomes, and to report lower levels of treatment optimization. Respondents reporting phonophobia as the MBS were more likely to have cutaneous allodynia and less likely to have visual aura.Conclusion.-Most people with migraine in the MAST observational study reported all 3 cardinal symptoms of nausea, photophobia, and phonophobia. As in clinical trials, the most common MBS was photophobia. Patient profiles differed among the groups defined by their MBS.

Objectives To characterize unmet treatment needs in a sample of Migraine in America Symptoms and Treatment (MAST) Study participants using oral, acute prescription migraine medications. Background The MAST Study is a 2017 study of US adults with migraine that profiles current treatment patterns and identifies and quantifies unmet treatment needs. Methods Cross‐sectional data from an online survey of US adults meeting ICHD‐3 beta criteria for migraine. For inclusion in this paper, respondents self‐reported a history of 3 or more monthly headache days (MHDs) in the past 3 months and at least 1 MHD in the past 30 days, and current use of orally administered acute prescription medication for headache. Three domains of unmet need were identified: inadequate treatment response (ie, inadequate 2‐hour pain freedom, recurrence within 24 hours of initial relief), demanding attack characteristics (rapid onset of attack, headache associated with sleep), and unique patient characteristics (opioid or barbiturate overuse, cardiovascular comorbidity). Sociodemographics, oral medication use, and coexisting conditions and symptoms (ie, level of treatment optimization, psychological symptoms, attack‐related cutaneous allodynia, and migraine symptom severity) were assessed for each domain and by the number of unmet need domains. Results Overall, 15,133 respondents met inclusion criteria, 26.0% (3930/15,133) reported current use of oral acute prescription medication to treat headache. Eligible participants had a mean age of 45.0 years, 73.6% [2892/3930] were women and 81.1% [3186/3930]) were White. A total of 95.8% (3765/3930) of respondents had at least 1 unmet acute treatment need; 89.5% (3516/3930) reported demanding attack characteristics, 74.1% (2912/3930) reported inadequate treatment response, and 16.1% (634/3930) presented with unique patient characteristics. Common areas of unmet need were rapid headache onset (65.3% [2567/3930]), moderate to severe disability (55.6% [2187/3930]), inadequate 2‐hours pain freedom (49.0% [1892/3930]), and headache recurrence within 24 hours (38.0% [1493/3930]). An increasing number of unmet treatment need domains was associated with worsening psychological symptoms, attack‐related cutaneous allodynia and migraine symptom severity. Conclusion Nearly all MAST Study respondents using acute oral prescription medications for migraine reported at least 1 unmet treatment need. As unmet needs increased, so did coexisting conditions and symptom severity.

Objective.-The objective of this study was to evaluate the efficacy, tolerability, and safety of 120 mg DFN-15 vs placebo for the acute treatment of migraine.Background.-Certain nonsteroidal anti-inflammatory drugs (NSAIDs) are guideline-recommended therapies for the acute treatment of migraine, but patients who use them may have issues with gastrointestinal tolerability. Celecoxib, a selective inhibitor of cyclooxygenase-2, produces analgesia similar to nonselective NSAIDs. DFN-15 is an oral, ready-made liquid solution of celecoxib being investigated for the acute treatment of migraine.Methods.-A randomized, double-blind, placebo-controlled, efficacy, tolerability, and safety study in adults with migraine was conducted. Subjects treated a single migraine attack with 120 mg DFN-15 or placebo as soon as possible after the onset of pain of moderate to severe intensity. The 2 independent coprimary efficacy endpoints were the proportion of subjects with freedom from pain and the absence of the most bothersome symptom (MBS) at 2 hours postdose. A second double-blind treatment period followed the first, but did not contribute to the primary outcomes and will be reported elsewhere.Results.-There were 622 subjects randomized (1:1) to double-blind treatment with either 120 mg DFN-15 or placebo, and 567 (91.2%) treated a migraine with study drug (n = 285 DFN-15; n = 282 placebo). Groups were balanced in demographic characteristics; the mean age was 40, and most subjects were female (87% [494/567]). At 2 hours postdose, DFN-15 was significantly superior to placebo for pain freedom (35.6% [98/275] vs 21.7% [57/263], P < .001), with an odds ratio (95% CI) of 2.00 (1.36, 2.94) and for freedom from the MBS (57.8% [134/232] vs 44.8% [104/232], P = .007), with an odds ratio (95% CI) of 1.68 (1.17, 2.43). A total of 13.3% (38/285) of DFN-15-treated subjects and 8.9% (25/282) of placebo-treated subjects reported a treatment-emergent adverse event (TEAE). Study drug-related TEAEs were reported by 9.1% (26/285) of DFN-15 subjects and 6.0% (17/282) of placebo subjects, the most common of which were dysgeusia (4.2% [12/285] vs 1.4% [4/282]) and nausea (3.2% [9/285] vs 1.8% [5/282]). No subjects treated with DFN-15 reported TEAEs that were severe or led to withdrawal, and no serious TEAEs or deaths were reported in the study.Conclusions.-DFN-15 was significantly more effective than placebo for the acute treatment of migraine, with a generally favorable tolerability and safety profile.