Headache最新文献

{"title":"The American Headache Society First Contact-Headache in Primary Care program: Current metrics, knowledge assessments, and direction for future initiatives.","authors":"Mia T Minen, Nisha A Malhotra, Erin K Waire, Hayley Z Swiderski, Nina Y Riggins, Adam S Sprouse-Blum","doi":"10.1111/head.14852","DOIUrl":"https://doi.org/10.1111/head.14852","url":null,"abstract":"<p><strong>Objective: </strong>This study examines the American Headache Society First Contact-Headache in Primary Care program metrics to date in order to assess the program's reach and provide direction for future initiatives.</p><p><strong>Background: </strong>Approximately 4 million primary care office visits annually are headache-specific encounters. Therefore, it is important that primary care providers are knowledgeable about headache management. Recognizing the need, the American Headache Society First Contact designed the comprehensive First Contact-Headache in Primary Care program with input from an advisory board comprised of a diverse group of physicians and advanced practice providers with backgrounds in family and internal medicine, pediatrics, obstetrics and gynecology, and neurology. This is the first study to assess the reach of the program and critically examine how to best meet the needs of clinicians and patients going forward.</p><p><strong>Methods: </strong>We report descriptive statistics for the First Contact website metrics from October 2020 to June 2023 and grand rounds program data from May 2020 to December 2023. We also conducted a cross-sectional analysis of survey data from presentations conducted at two large national family medicine symposia, as well as a thematic analysis of the question: \"Please indicate what areas of your practice could be enhanced or improved with additional education?\"</p><p><strong>Results: </strong>The First Contact program homepage was the second most visited page on the American Headache Society website (>100,000 views). A total of 20 podcast episodes were created for the program (>3500 plays). The First Contact program held 99 events (72 institutional grand rounds, 22 State-level meetings, and five national meetings), reaching >7000 clinicians. The institutional grand rounds and state-level meetings were held across 27 States and Washington D.C. Only 31.9% (30/94) of First Contact program events (excluding national meetings) occurred in the West census region, which has the fewest headache subspecialists and lowest headache subspecialist density in the United States. When examining survey data of participants who attended the two virtual national family medicine symposia (39.3% response rate, N = 636/1620), 85.7% (544/635) reported being \"completely confident\" or \"very confident\" in their ability to recognize and accurately diagnose patients presenting with a primary complaint of headache and 81.5% (517/634) reported being \"completely confident\" or \"very confident\" in their ability to develop evidence-based treatment plans that are tailored to the needs of individual patients. The use of diagnostic tools to recognize patients with migraine (60.4%, 384/636) and translating standards of care to the practice setting (42.5%, 270/636) were the most reported intended changes by participants. Most participants reported that program content was of clinical relevance and would improve their patien","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The PATCH trial: 5% lidocaine-medicated plaster for trigeminal neuralgia-Results of a multicentric, enriched enrollment, randomized withdrawal, double-blind, vehicle-controlled, parallel-group study.","authors":"Chunmei Zhao, Niti Shrestha, Hao Ren, Baohui Zhang, Ying Shen, Lan Meng, Dasheng Wu, Baoguo Wang, Bifa Fan, Fang Luo","doi":"10.1111/head.14814","DOIUrl":"10.1111/head.14814","url":null,"abstract":"<p><strong>Objective: </strong>To explore the efficacy and safety of 5% lidocaine-medicated plaster (LMP) in patients with trigeminal neuralgia (TN).</p><p><strong>Background: </strong>TN is an excruciatingly painful type of neuropathic facial pain. Anti-epileptics are the first-line treatment for TN; however, these oral drugs alone sometimes fail to achieve satisfactory analgesic effects. Two retrospective studies have shown that LMP can be an effective and safe treatment option for some patients with TN. No other high-quality clinical studies have explored the effect and safety of LMP in patients with TN.</p><p><strong>Methods: </strong>The PATCH trial is an enriched enrollment with randomized withdrawal, double-blind, vehicle-controlled, parallel-group trial performed at five study centers. Eligible patients with TN received LMP during a 3-week initial open-label phase. Patients who met the response criteria entered the double-blind treatment phase and were randomly assigned for treatment with either LMP (LMP group) or vehicle patches (control group) at a 1:1 ratio. Patients who met the criteria for treatment failure were withdrawn from the double-blind treatment phase, and treatment was continued in the remaining patients for up to 28 days. The primary outcome was the number of treatment failures. The secondary endpoints were the time to loss of therapeutic response (LTR) in the double-blind phase and the weekly mean pain severity in both the open-label phase and the double-blind phase of the study.</p><p><strong>Results: </strong>The first patient was enrolled in this study on May 1, 2021, and the enrollment of the last patient was completed on August 26, 2022. A total of 307 patients were initially screened, 226 (74.0%) of whom entered the open-label phase. Of the 226 respondents, 124 (55.0%) were randomized to the double-blind phase. In the double-blind phase, 62 patients were assigned to the LMP group, and 62 were assigned to the control group. For the primary endpoint, 16 (26.0%) patients with LMP and 36 (58.0%) patients with vehicle patches met the treatment failure criteria during the double-blind phase (relative risk, 0.48; 95% confidence interval [CI], 0.31 to 0.75; p < 0.001). The survival curve of the LTR showed that the LTR of LMP was significantly longer than that of the vehicle patches (hazard ratio, 0.275; 95% CI, 0.15 to 0.50; log-rank p < 0.001). LMP also significantly reduced the weekly mean pain severity in the double-blind phase of the study (p = 0.007).</p><p><strong>Conclusions: </strong>LMP produced partial relief of pain symptoms in some patients with TN. For responders, LMP may be used as an add-on therapy in a multidrug treatment protocol.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1318-1328"},"PeriodicalIF":5.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142080095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The safety and efficacy of onabotulinumtoxinA injections for children and adolescents with chronic migraine: A systematic review and meta-analysis.","authors":"Rebecca Lindsay, Amira Kalifa, Jonathan Kuziek, Marielle Kabbouche, Andrew D Hershey, Serena L Orr","doi":"10.1111/head.14798","DOIUrl":"10.1111/head.14798","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To qualitatively and quantitatively summarize the evidence for the use of onabotulinumtoxinA injections in children and adolescents with migraine.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;There are limited evidence-based treatment options for youth with migraine, especially youth with chronic migraine (CM). OnabotulinumtoxinA injections are an established evidence-based treatment for adults with CM. While several studies have assessed their safety and efficacy among adolescents with CM, there are no published systematic reviews summarizing the pediatric evidence.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We carried out a systematic review, reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis, aiming to identify studies that included five or more children and adolescents aged ≤18 years with a diagnosis of migraine, who were treated with ≥50 units (U) of onabotulinumtoxinA and had outcomes assessed ≥4 weeks after one or more injection cycle. Both observational studies and randomized controlled trials (RCTs) were eligible for inclusion. Two investigators independently carried out the first (titles and abstracts) and second (full text) screening stages, as well as data extraction and quality appraisal. The American Academy of Neurology risk of bias grading scheme was used to assess study risk of bias. Studies with adequate data were pooled using random effects meta-analyses, and Hedge's g standardized mean differences with 95% confidence intervals (CIs) were generated to estimate the effect sizes of the continuous outcomes included. Studies lacking data required for meta-analysis were summarized qualitatively.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;We screened 634 studies and included 14 studies comprising 491 participants, of whom 489 had CM. Two studies were RCTs, 12 were observational uncontrolled studies, and all but one study included only youth with CM. Five Class IV observational uncontrolled studies were amenable to pooling in meta-analyses. After a mean of 2-2.6 injection cycles, headache frequency was shown to decrease significantly after treatment with onabotulinumtoxinA (Hedge's g = 0.97, 95% CI 0.58-1.35; p &lt; 0.0001), as did severity (Hedge's g = 1.24, 95% CI 0.55-1.94; p = 0.0005), with both estimates having a large effect size magnitude. A Class I parallel-group RCT of one injection series (155 U, 74 U, or placebo), powered to detect a change in 4 headache days per month, did not find outcome differences between the active and placebo treatment arms. A Class IV crossover RCT showed superiority of active (155 U) versus placebo injections. The remaining Class IV observational studies that were excluded from the meta-analyses all showed improved outcomes with onabotulinumtoxinA injections over time. No serious adverse events related to treatment occurred.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;OnabotulinumtoxinA injections have established safety for use in children and adolescents with CM and ar","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1200-1216"},"PeriodicalIF":5.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141916575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cluster Analysis of Migraine-associated Symptoms (CAMS) in youth: A retrospective cross-sectional multicenter study.","authors":"Carlyn Patterson Gentile, Christina L Szperka, Andrew D Hershey","doi":"10.1111/head.14859","DOIUrl":"10.1111/head.14859","url":null,"abstract":"<p><strong>Objective: </strong>To conduct a retrospective cross-sectional multicenter study to validate the relationships between migraine-associated symptoms.</p><p><strong>Background: </strong>Symptoms associated with headache-photophobia and phonophobia, nausea, and/or vomiting-are required criteria for migraine diagnosis based on the International Classification of Headache Disorders-Third Edition (ICHD-3). However, individuals with migraine report high rates of other symptoms (e.g., lightheadedness, difficulty thinking). We recently completed a single-center study assessing the relationships between an expanded set of migraine-associated symptoms.</p><p><strong>Methods: </strong>A pre-registered cross-sectional multicenter retrospective analysis was conducted on standardized questionnaire data of youth ages 6-17 years from two headache registries at pediatric tertiary care centers. Cluster Analysis of Migraine-associated Symptoms (CAMS) was implemented to assess associations between 11 migraine-associated symptoms. We explored differences between the two centers, and how CAMS was associated with demographics, including sex and age, and headache burden.</p><p><strong>Results: </strong>There were 10,721 participants who were 66.5% female and had a median (interquartile range) age of 13 (10-15) years. The first three CAMS dimensions accounted for 46.5% of the variance and were consistent across sites. The first dimension indicated those reporting any migraine-associated symptoms were likely to report multiple. The second dimension separated symptoms into those included in ICHD-3 migraine diagnostic criteria and non-ICHD symptoms (e.g., lightheadedness, difficulty thinking). The third dimension separated sensory hypersensitivity and vestibular symptoms. An abundance of migraine-associated symptoms correlated with greater headache severity (Spearman's ρ = 0.18, 95% confidence interval [CI] 0.17-0.20; small effect size) and disability (ρ = 0.26, 95% CI 0.25-0.28; small effect size). We also observed differences in associated symptoms across age and sex.</p><p><strong>Discussion: </strong>Associations between an expanded set of migraine-associated symptoms are informative for headache burden and reveal intriguing changes across child development and sex. We were able to replicate findings across two centers, indicating that these symptom clusters are inherent to migraine.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1230-1243"},"PeriodicalIF":5.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11560594/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499073","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A critical appraisal of the International Classification of Headache Disorders migraine diagnostic criteria based on a retrospective multicenter cross-sectional headache registry study in youth.","authors":"Carlyn Patterson Gentile, Andrew D Hershey, Christina L Szperka","doi":"10.1111/head.14858","DOIUrl":"10.1111/head.14858","url":null,"abstract":"<p><strong>Objectives: </strong>We used Cluster Analysis of Migraine-associated Symptoms (CAMS) to critically evaluate current International Classification of Headache Disorders-Third Edition (ICHD-3) migraine-associated symptoms criteria.</p><p><strong>Background: </strong>Diagnostic criteria play a central role in guiding clinical trial inclusion, and therefore available treatments. Migraine and tension-type headaches (TTH) are differentiated in ICHD-3 by many headache characteristics, including associated symptoms. A diagnosis of probable migraine indicates some but not all features of migraine are met. Photophobia and phonophobia, or nausea and/or vomiting, are required to meet a diagnosis of migraine; however, CAMS-a model that describes associated symptoms across youth with headache-indicates that a broader range of symptoms contain information about migraine burden.</p><p><strong>Methods: </strong>In this multisite retrospective cross-sectional study, we evaluated ICHD-3 migraine criteria. Youth aged 6-17 years with migraine (including probable migraine) or TTH were included in the analysis. We used CAMS to evaluate the migraine-associated symptom criterion. With CAMS as a guide, we evaluated how changes to the migraine-associated symptom criterion altered who met the diagnosis of migraine.</p><p><strong>Results: </strong>Of the 9017 participants included in this study, 66.7% were female and had a median (interquartile range) age of 13 (10-15) years. Most participants had migraine or probable migraine (99.0%), and the remainder had TTH (1.0%). A sizable percentage (10.1%) of youth under the umbrella diagnosis of migraine were diagnosed with probable migraine because they did not meet migraine-associated symptom criterion D; however, many in this group reported several non-ICHD migraine-associated symptoms. We explored alterations to criterion D based on CAMS. Allowing for photophobia or phonophobia re-categorized 55.6% of youth as having migraine, though some only had one symptom. Including lightheadedness or lightheadedness and spinning re-categorized 19.7% and 25.8% of youth with migraine, respectively, but all of those who were re-categorized had at least two migraine-associated symptoms.</p><p><strong>Conclusion: </strong>The ICHD-3 captures the most prevalent migraine-associated symptoms; however, many youths with probable migraine who do not meet full criteria due to insufficient associated symptoms nonetheless experience multiple non-ICHD migraine-associated symptoms. Changes to criterion D should be considered for the ICHD-4.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1217-1229"},"PeriodicalIF":8.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11560481/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499071","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effectiveness of parenteral agents to mitigate relapses after severe acute migraine headache presentations: A systematic review and network analysis.","authors":"Scott Kirkland, Jillian Meyer, Lloyd Visser, Sandra Campbell, Cristina Villa-Roel, Benjamin W Friedman, Nana Owusu Essel, Brian H Rowe","doi":"10.1111/head.14841","DOIUrl":"10.1111/head.14841","url":null,"abstract":"<p><strong>Objectives: </strong>To compare the effectiveness of parenteral agents to reduce relapse in patients with acute migraine and identify factors that predict relapse.</p><p><strong>Background: </strong>Following discharge from emergency settings, many patients with acute migraine will experience a relapse in pain; severe relapses may result in re-visits to emergency settings.</p><p><strong>Methods: </strong>A comprehensive literature search, updated to 2023, was conducted to identify randomized controlled trials assessing the effectiveness of parenteral agents on relapse outcomes in patients with acute migraine discharged from emergency settings. Two independent reviewers completed study selection, quality assessment, and data extraction. A traditional meta-analysis compared parenteral corticosteroids to placebo; a frequentist network analysis assessed direct and indirect comparisons. Results are reported as risk ratios (RRs) and 95% confidence intervals (CIs). The review protocol was registered with the International Prospective Register of Systematic Reviews (identifier: CRD42018099493).</p><p><strong>Results: </strong>From 8949 citations, a total of 53 unique studies were included involving 6167 patients. Most studies had a high or unclear risk of bias. Corticosteroids significantly reduced relapses compared to placebo (RR 0.67, 95% CI 0.52-0.88; I² = 0%). Patients receiving lidocaine (RR 0.10, 95% CI 0.01-0.82), sedatives/hypnotics (RR 0.33, 95% CI 0.14-0.75), ergot agents (RR 0.44, 95% CI 0.25-0.75), neuroleptics (RR 0.47, 95% CI 0.31-0.71), opioids (RR 0.58; 95% CI 0.35-0.94), or corticosteroids (RR 0.64, 95% CI 0.47-0.86) were significantly less likely to relapse. Lidocaine (RR 0.09, 95% CI 0.01-0.71), combination therapy (RR 0.12, 95% CI 0.02-0.74), or adding corticosteroids (RR 0.61, 95% CI 0.44-0.84) were more likely to reduce severe relapses. Longer duration of headache and residual pain at discharge were significantly associated with higher relapses.</p><p><strong>Discussion: </strong>Corticosteroids remain the recommended first-line option to reduce relapse outcomes. Some parenteral agents typically provided for pain relief including ergot agents, neuroleptics, or combination therapy may effectively reduce relapse; however, opioids are not recommended due to safety concerns. Additional research is needed for some lesser studied, albeit promising, agents including lidocaine and propofol. Effective pain control in emergency settings prior to discharge and duration of headache may play a role in the success of such treatments and further investigations could provide further insight regarding how and why some parenteral agents are effective in mitigating relapse events.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1181-1199"},"PeriodicalIF":5.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The 2024 Scottsdale Headache Symposium: A banner year.","authors":"Deborah I Friedman, Carrie Dougherty, Scott W Powers","doi":"10.1111/head.14855","DOIUrl":"10.1111/head.14855","url":null,"abstract":"","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1179-1180"},"PeriodicalIF":5.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142463323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The impact of updates in headache quality measures on adherence to best practices in a neurology resident clinic: A quality improvement study.","authors":"Robert H Cascella, Christopher C Anderson, Enmanuel J Perez","doi":"10.1111/head.14754","DOIUrl":"10.1111/head.14754","url":null,"abstract":"<p><strong>Objective: </strong>To apply the 2019 joint American Academy of Neurology (AAN) and American Headache Society (AHS) quality measures for headache management to a cohort of neurology resident physicians and then assess outcomes related to guideline adherence.</p><p><strong>Background: </strong>The optimization of headache management is essential to reduce both the individual and systemic impact of these disorders. In 2014, the AAN developed 10 quality measures for evidence-based management of patients with headache. A workgroup updated and condensed its headache quality measures in 2019, narrowing the set to six measurements, four of which would primarily focus on the management of migraine and two of which would address the management of cluster headache.</p><p><strong>Methods: </strong>This quality improvement study was conducted using a pretest-posttest study design. A pre-intervention survey based on retrospective analysis of five clinic notes for adherence to the measures was designed and distributed to all neurology residents (n = 32) at a large, academic tertiary referral center. The intervention included the creation of an electronic medical record template to aid residents in following the measures during clinical encounters, as well as the provision of direct feedback based on pre-intervention results. Finally, a post-intervention survey was distributed for completion based on notes written during the intervention period. Analysis was limited to migraine, given the low percentage of cluster headache seen in clinic.</p><p><strong>Results: </strong>An increase in adherence was seen in three of the four migraine-related quality measures, with the Use of Abortive Medications for Migraine and Documentation of Counseling on Modifiable Lifestyle and Chronification Factors demonstrating statistically significant improvements (75.8% to 88.0% [p = 0.013] and 83.9% to 94.0% [p = 0.029] adherence, respectively). For secondary outcomes, the increase in the utilization of appropriate diagnostic criteria (82.6% to 93.2%, p = 0.018) was significant, and the self-assessed confidence rating for adherence to guidelines was significant (p < 0.001).</p><p><strong>Conclusions: </strong>This study provides evidence that the quality improvement intervention led to increased adherence to the AAN and AHS migraine-related measures. It is anticipated that increased adherence may lead to improved patient outcomes.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1329-1335"},"PeriodicalIF":5.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141456358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ubrogepant users' real-world experience: Patients on ubrogepant, characteristics and outcomes (UNIVERSE) study.","authors":"Anand R Shewale, Weijie Poh, Michael L Reed, Jinjie Liu, Francois Cadiou, Ali Ezzati, Kate Burslem, Shivaji Manthena, Richard B Lipton","doi":"10.1111/head.14839","DOIUrl":"10.1111/head.14839","url":null,"abstract":"<p><strong>Objective: </strong>To assess the real-world effectiveness of ubrogepant by evaluating self-reported satisfaction with pain relief, ability to think clearly, and return to normal function in individuals who had used ubrogepant to treat a migraine episode within the preceding 14 days.</p><p><strong>Background: </strong>Ubrogepant is an oral calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine in adults. Few studies have evaluated the real-world effectiveness of ubrogepant.</p><p><strong>Methods: </strong>The UNIVERSE study was an observational, cross-sectional survey conducted between February 2021 and April 2021 in US adult Migraine Buddy application (app) users currently treated with ubrogepant. Individuals who were 18 years of age or older and reported at least one dose of ubrogepant in the previous 14 days completed a 30-question survey in the app. The survey assessed respondent demographics, migraine history, acute treatment patterns, and treatment satisfaction with ubrogepant. Respondents also reported prior acute medication use and reasons for switching to ubrogepant.</p><p><strong>Results: </strong>Of the 1303 ubrogepant users contacted, 302 (23.2%; 50 mg, 120 participants; 100 mg, 182 participants) were included in this study. The mean (standard deviation) age was 41.9 (11.2) years, and 90.1% (272/302) were female. Satisfaction with migraine relief at 2, 4, and 24 h post-dose was reported by 75.8% (229/302), 83.4% (252/302), and 78.5% (237/302) of participants, respectively. Satisfaction with the ability to think clearly after taking ubrogepant was reported by 85.1% (257/302) of participants, and 83.8% (253/302) were satisfied with their ability to return to normal function. Furthermore, 90.7% (274/302) of participants reported that they were likely to continue using ubrogepant to treat their migraine. Most participants (n = 264 [87%]) reported switching to ubrogepant due to inadequate treatment response with their previous treatment. In this subgroup, comparable outcomes were observed with respect to satisfaction with migraine relief, ability to think clearly, and return to normal function.</p><p><strong>Conclusions: </strong>Ubrogepant demonstrated real-world effectiveness in the acute treatment of migraine, as evidenced by high levels of treatment satisfaction and a strong indication of their intent to continue using the medication.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1244-1252"},"PeriodicalIF":5.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142345160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost per treatment responder analysis of atogepant compared to rimegepant for the preventive treatment of episodic migraine.","authors":"Jessica Ailani, Pranav Gandhi, Anjana Lalla, Rashmi Halker Singh, Peter McAllister, Jonathan H Smith, Brett Dabruzzo, Natty Chalermpalanupap, Kari Kelton, Stephanie J Nahas","doi":"10.1111/head.14824","DOIUrl":"10.1111/head.14824","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To estimate the number needed to treat and cost per additional responder for atogepant and rimegepant versus placebo for the preventive treatment of episodic migraine (EM) in the United States.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Migraine has an enormous impact on a person's daily activities and quality of life, and results in significant clinical and economic burden to both individuals and society. It is important to understand the comparative efficacy and economic value of oral calcitonin gene-related peptide receptor antagonists (gepants) for preventive treatment of EM. Currently, atogepant and rimegepant are US Food and Drug Administration approved for preventive treatment of migraine (rimegepant for EM and atogepant for EM and for chronic migraine). In the absence of head-to-head trials, we utilized an indirect treatment comparison on efficacy data from clinical trials conducted for the preventive treatment of EM. We estimated number needed to treat, a valuable metric used in clinical practice to compare treatment efficacy, and cost per additional responder, which can be used to establish the cost effectiveness of a treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;An indirect treatment comparison was conducted to compare the efficacy of atogepant 60 mg once daily and rimegepant 75 mg once every other day as preventive treatments for EM using published data from the registrational trials of atogepant (ADVANCE) and rimegepant (BHV3000-305). The efficacy outcome of interest was ≥50% reduction from baseline in mean monthly migraine/headache days (≥50% responder rate), which was variably defined for a base case and two scenario analyses. Number needed to treat and cost per additional responder versus placebo were calculated and compared between both treatments (weeks 9-12 in the base case analysis; weeks 1-12 and 9-12 for atogepant and during weeks 9-12 for rimegepant in the scenario analyses).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;In the base case analysis, ≥50% responder rates were 64.9% (95% confidence interval [CI], 53.9-74.5) for atogepant and 51.8% (95% CI, 42.9-60.6) for rimegepant, compared to 44.1% (95% CI, 39.4-49.0) for placebo. The median number needed to treat versus placebo in the base case scenario was 4.8 (95% CI, 3.1-9.0) for atogepant compared to 13.0 (95% CI, 5.9-75.1) for rimegepant. The cost per additional responder versus placebo in the base case scenario was estimated to be $15,823 (95% CI, $11,079-$29,516) for atogepant compared to $73,029 (95% CI, $32,901-$422,104) for rimegepant. Results of the two scenario analyses were consistent with the base case analysis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Atogepant had substantially lower numbers needed to treat and costs per additional responder versus placebo than rimegepant for the preventive treatment of EM across all evaluated scenarios. These analyses suggest that atogepant may be more cost effective than rimegepant for the preventive treatment of EM. Limit","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1253-1263"},"PeriodicalIF":5.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}