Migraine In Adults Research Articles

Reducing the Burden of Migraine: Safety and Efficacy of CGRP Pathway-Targeted Preventive Treatments.

Migraine is a highly disabling and often chronic neurological disease that affects more than one billion people globally. Preventive migraine treatment is recommended for individuals who have frequent and/or disabling attacks; however, many of the medications used for migraine prevention (e.g., antiepileptics, antidepressants, antihypertensives) were not specifically developed for migraine, and often have limited efficacy or poor tolerability. Four monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway, which is believed to play a crucial role in the pathophysiology of migraine, have been approved by the US Food and Drug Administration for the preventive treatment of migraine in adults. All four migraine-specific treatments have demonstrated efficacy based on reductions in monthly days with migraine for patients with both episodic and chronic migraine, including those with comorbidities. They have also demonstrated favorable safety and tolerability profiles. Based on these accounts, CGRP pathway-targeted monoclonal antibodies have the potential to revolutionize preventive treatment for patients with migraine.

Long-term reductions in disease impact in patients with chronic migraine following preventive treatment with eptinezumab

BackgroundEptinezumab is an anti-calcitonin gene-related peptide humanized monoclonal antibody approved for the preventive treatment of migraine in adults. The PREVAIL study demonstrated a favorable safety profile with sustained reductions in overall migraine-related burden in patients with chronic migraine (CM). This post hoc analysis aimed to examine item-level changes in the Migraine Disability Assessment (MIDAS) questionnaire over 2 years in participants with CM on eptinezumab treatment.MethodsPREVAIL was an open-label, phase 3 trial that included 96 weeks of treatment where 128 adults received intravenous eptinezumab administered over 30 min every 12 weeks (wks) for up to 8 doses of 300 mg. MIDAS was administered at baseline, Wk12, and every 12wks thereafter. Two supplementary MIDAS items not included in the total score calculation assessed number of headache days in the past 3 months (MIDAS headache) and average headache pain severity (from 0 [none] to 10 [worst]). MIDAS total scores were summed from 5 items, each quantifying the number of days in the past 3 months with migraine-related disability. Items 1, 3, and 5 assessed absenteeism, namely how many days the patient missed work/school (Q1), household work (Q3), or family/social/leisure activities (Q5). Items 2 and 4 were measures of presenteeism, namely how many days the patient had reduced productivity in work/school (Q2) or household work (Q4).ResultsMean MIDAS headache days decreased from 47.4 (baseline) to 17.1 (Wk12) and 16.3 (Wk104). The average headache pain severity score (0‒10) decreased from a mean of 7.3 (baseline) to 5.5 (Wk12) to 4.5 (Wk104). Mean MIDAS scores measuring absenteeism (Q1, 3, 5) changed from 9.7 days at baseline to 3.2 days (Wk12) and to 3.9 days (Wk104). Mean MIDAS scores measuring presenteeism (Q2, 4) at Wk12 decreased from 14.2 days at baseline to 5.2 days (Wk12, 104). Patients categorized with very severe MIDAS disability had a mean total MIDAS score of 84.8, with an average reduction of 56.7 days (Wk12), which was maintained at 32 days at Wk104.ConclusionsLong-term treatment with eptinezumab in patients with CM suggested sustained reductions in MIDAS-quantified disability, consistent with the sustained reductions in headache frequency and pain severity.Trial registrationClinicalTrials.gov identifier: NCT02985398.

Potential Channeling Bias in the Evaluation of Cardiovascular Risk: The Importance of Comparator Selection in Observational Research.

BackgroundComparator selection is an important consideration in the design of observational research studies that evaluate potential associations between drug therapies and adverse event risks. It can affect the validity of observational study results, and potentially impact data interpretation, regulatory decision making, and patient medication access.ObjectiveThe aim of this study was to assess the impact of comparator selection bias using two real-world case studies evaluating an increased rate of acute myocardial infarction (AMI).MethodsData from the Truven Health Analytics MarketScan® electronic medical claims database were used to conduct two retrospective observational cohort studies, utilizing a cohort new-user design, comparing AMI risk between testosterone replacement therapy (TRT) and phosphodiesterase-5 inhibitors (PDE5is) in men treated for hypogonadism, and triptans versus other prescribed acute treatments for migraine in adults. All patients were enrolled continuously in a health plan (no enrollment gap > 31 consecutive days) for ≥ 1 year before index. Baseline period was defined as 365 days prior to index. Exposure was defined by prescription and outcome of interest was defined as occurrence of AMI. Using Cox proportional hazard models, primary analysis for the TRT cohort compared AMI risk between propensity score (PS)-matched TRT-treated and untreated patients; secondary analysis evaluated risk between PS-matched TRT-treated and PDE5i-treated patients. For the triptan cohort, primary analysis compared AMI/ischemic stroke risk between PS-matched triptan-treated and opiate-treated patients; secondary analysis evaluated risk between PS-matched triptan-treated and nonsteroidal anti-inflammatory drug (NSAID)-treated patients and PS-matched non-prescription-treated migraine patients and general patients.ResultsNo significant association between TRT and AMI was observed among TRT-treated (N = 198,528, mean age 52.4 ± 11.4 years) versus PDE5i-treated men (N = 198,528, mean age 52.3 ± 11.5 years) overall (adjusted hazard ratio [aHR] 1.01; 95% CI 0.95–1.07; p = 0.80). Among patients with prior cardiovascular disease (CVD), risk of AMI was significantly increased for TRT-treated versus PDE5i-treated patients (aHR 1.13; 95% CI 1.03–1.25). The triptan study included three comparisons (triptans [N = 436,642] vs prescription NSAIDs [N = 334,152], opiates [N = 55,234], and untreated migraine [N = 1,168,212]), and a positive control (untreated vs general non-migraine patients [N = 11,735,009]). Analyses of MI risk in migraine patients prescribed triptans versus NSAIDs/opiates had mixed results: the point estimate ranged from 0.33 to 0.84 depending on chosen study window.ConclusionsCardiovascular outcomes were not worse in hypogonadism patients with TRT versus PDE5i; however, a potential association with AMI was found in patients with prior CVD receiving TRT versus PDE5i. Findings pointed to a pseudo-protective effect of triptans versus untreated migraine patients or those potentially older and less healthy patients exposed to prescription NSAIDs or opiates. Triptan users should not be compared with those using other anti-migraine prescriptions when evaluating cardiovascular outcomes in migraine patients. Presence of high cardiovascular risks may contribute to channeling bias—healthier subjects being selected to receive treatment—highlighting the importance of choosing comparators wisely in observational studies.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40290-022-00433-z.

Efficacy and Safety of Melatonin as Prophylaxis for Migraine in Adults: A Meta-analysis.

To evaluate the efficacy and safety of melatonin for migraine prophylaxis in adults. After a comprehensive literature search in the MEDLINE, Cochrane Database, and International Clinical Trial Registry Platform databases, reviewers extracted data from three relevant articles. PRISMA guidelines were followed in the selection, analysis, and reporting of the findings. Quality assessment was performed using the Cochrane risk of bias assessment tool. A random-effects model was used to estimate the effect size, and meta-regression was performed for variables with a likely influence on effect size. Subgroup analysis was performed based on the comparison used in the included studies. Melatonin therapy in migraine was associated with a significantly higher responder rate when compared to both placebo and standard therapy (OR = 1.84; 95% CI: 1.08 to 3.14; P = .03). The results of the meta-analyses indicated that melatonin can achieve a significant reduction in frequency of migraine attacks (MD = 1.00; 95% CI: 0.02 to 1.98; P = .04), migraine attack duration (MD = 5.02; 95% CI: 0. 91 to 9.13; P = .02), use of analgesics (MD = 1.43; 95% CI: 0.38 to 2.48; P = .008), and migraine severity (MD = 1.93; 95% CI: 1.23 to 2.63; P < .0001) over placebo, but had no significant effects in comparison to amitriptyline or valproate. There was no significant difference in the occurrence of common adverse drug reactions, such as drowsiness and fatigue, between the melatonin group and the comparison groups. Melatonin showed a beneficial prophylactic role in migraine, with a better responder rate in comparison to placebo in reducing migraine severity, mean attack duration, mean attack frequency, and analgesic use, but did not show significant effects in comparison to amitriptyline or valproate.

Migraine, Cognitive Decline, and Dementia in Older Adults: A Population-Based Study.

The potential impact of migraine on cognitive aging among older adults remains controversial. To examine the relationship of migraine and subtypes with cognitive decline and dementia in an older Swedish population. This population-based study included 3,069 participants (age ≥ 60 years) from the Swedish National study on Aging and Care in Kungsholmen, Stockholm. Baseline examination was conducted in 2001-2004, and participants were followed every 3 or 6 years until 2013-2016. Data were collected through face-to-face interviews, clinical examinations, laboratory tests, and linkage with registers. Global cognitive function was measured with the Mini-Mental State Examination (MMSE). Dementia was diagnosed according to the DSM-IV criteria. Migraine and subtypes were defined following the international classification system. Data were analyzed using logistic regression, Cox regression, and linear mixed-effects models. At baseline, 305 participants were defined with non-migraine headache and 352 with migraine. The cross-sectional analysis showed that the multivariable-adjusted odds ratio (95% confidence interval) of prevalent dementia was 0.49 (0.20-1.21) for migraine and 0.66 (0.26-1.66) for migraine without aura. The longitudinal analysis showed that the multivariable-adjusted hazard ratios of incident dementia associated with migraine and subtypes ranged 0.68-0.89 (p > 0.05). Furthermore, migraine and subtypes were not significantly associated with either baseline MMSE score or MMSE changes during follow-ups (p > 0.05). The nonsignificant associations did not vary substantially by age, APOEɛ4 allele, cerebrovascular disease, and antimigraine treatment (p for interactions > 0.05). This study shows no evidence supporting the associations of migraine and its subtypes with cognitive decline and dementia among older adults.

CO114 Real-World Reductions in Acute Medication Use for Patients with Migraine Initiating Fremanezumab: A 12-Month Retrospective US Claims Analysis

Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is approved for preventive treatment of migraine in adults. A prior database study found claims for acute medication were reduced 6 months post-initiation of fremanezumab versus 6 months pre-initiation. Twelve-month post-initiation data are now available. Changes in acute medication use in the 12 months prior to fremanezumab initiation and during a 12-month follow-up period were retrospectively analyzed.

EE57 Real-World Reductions in Migraine-Related Health Care Resource Utilization and Costs for Patients Initiating Fremanezumab: A 12-Month Retrospective US Claims Analysis

Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is approved for preventive treatment of migraine in adults. This retrospective analysis assessed baseline patient characteristics and migraine-related health care resource utilization (HCRU) and costs in US patients with migraine 12 months before and 12 months after initiating fremanezumab treatment.

Atogepant for the Prevention of Episodic Migraine in Adults: A Systematic Review and Meta-Analysis of Efficacy and Safety.

IntroductionThe inhibition of the calcitonin gene-related peptide (CGRP) pathway has attracted interest in pharmacological research on migraine. Atogepant is a potent, selective, orally available antagonist of the CGRP receptor approved as a preventive treatment of episodic migraine. This systematic review with meta-analysis aims to evaluate the efficacy and safety of atogepant for the prevention of episodic migraine in adult patients.MethodsRandomized, placebo-controlled, single or double-blinded trials were identified through a systematic literature search (December week 4, 2021). Main outcomes included the changes from baseline in monthly migraine days and the incidence of adverse events (AEs) and treatment withdrawal due to AEs. Mean difference (MD) and risk ratio (RR) with 95% confidence intervals (95% CIs) were estimated.ResultsTwo trials were included, overall enrolling 1550 patients. A total of 408 participants were randomized to placebo, 314 to atogepant 10 mg, 411 to atogepant 30 mg, and 417 to atogepant 60 mg once daily. The mean age of the patients was 41.0 years and 87.7% were women. The reduction in the mean number of migraine days from baseline across the 12-week treatment period was significantly greater among patients treated with atogepant at either the daily dose of 10 mg (MD − 1.16, 95% CI − 1.60 to − 0.73, p < 0.001), 30 mg (MD − 1.15, 95% CI − 1.54 to − 0.76, p < 0.001), or 60 mg (MD − 1.20, 95% CI − 2.18 to − 0.22, p = 0.016) than with placebo. There were no differences in the occurrence of AEs and drug withdrawal due to AEs between atogepant and placebo groups. Constipation was more commonly observed in patients treated with atogepant at 30 mg/day than placebo (RR 5.19, 95% CI 2.00–13.46; p = 0.001). Treatment with atogepant at the daily dose of 60 mg was associated with a higher risk of constipation (RR 4.92, 95% CI 1.89–12.79; p = 0.001) and nausea (RR 2.73, 95% CI 1.47–5.06; p = 0.001) than placebo.ConclusionAtogepant is an efficacious and overall well-tolerated treatment for the prevention of episodic migraine in adults.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40120-022-00370-8.

Association of migraine with Gastritis in Pakistani young adults and its impact on their educational performance

Young adults worldwide are suffering from migraine as well as from gastritis problems. Reportedly, both of these situations has been occurring at the same time in young adults. For this purpose, a sample size of 30 subjects ranging from 10-24years, who were suffering from gastritis were selected in this study. To conduct the analysis, the subjects filled the questionnaires, in the presence of an investigator. This questionnaire comprised migraine differentiation questions, lifestyle factors, and the Migraine Disability Assessment test (MIDAS). MIDAS was used to estimate the impact of migraine on the class performance of young adults. With female to male ratio of 3.3:1, the average age of participants was 10-24. The prevalence of migraine associated with gastritis was found to be 53.3% significant. A significant relationship was identified between migraine, gastritis, and migraine in young adults. MIDAS test indicated that migraine had a significant impact on the class performance of young adults indicating that no impact, mild impact, moderate impact, and severe impact had a prevalence of 26.7%, 30%, 26.7%, and 16.7%, respectively. Hence, significant associations were found between migraine and gastritis in the young adults. Shocking alteration in the lifestyle of Pakistani community was seen, while conducting this study. Further studies can be conducted to understand the factors associated with day-by-day altering trends in the country.

Migraine Pathophysiology in Children and Adolescents: A Review of the Literature.

Although migraine in adult and pediatric patients are overall very similar to each other, differences in prevalence, presentation, and treatment efficacy may reflect slight differences in the pathophysiological processes underlying migraine in these patient groups, perhaps because of ongoing development of the nervous system during childhood and adolescence. Although major gains have been made in understanding the pathophysiology of migraine in adults in recent years, equivalent research on migraine in pediatric patients continues to lag behind. In this review, we will describe the current state of migraine research in pediatric patients with regard to presentation and frequency of prodromal and postdromal symptoms, ictal and interictal calcitonin gene-related peptide elevation, and evidence for cortical spreading depression, thus covering all phases of migraine, and discuss how the findings seen here may relate to possible underlying pathophysiological mechanisms of migraine. We aim to elucidate possible differences between migraine in children and adults, and the need for further research specific to pediatric patients with migraine in order to improve treatment in this patient group.

Pfizer to buy Biohaven for $11.6 billion

Seeking Nurtec, a pill approved to treat and prevent migraine in adults, Pfizer has agreed to acquire its maker, Biohaven Pharmaceuticals, in a cash deal valued at $11.6 billion. Pfizer has plenty of cash on hand, thanks to sales of its COVID-19 antiviral Paxlovid and its COVID-19 vaccine Comirnaty. It is now looking to Nurtec (rimegepant), a small-molecule drug considered a potential blockbuster for an underserved therapeutic category, as part of the bulwark it is building against future patent expiries. “The deal fulfills Pfizer’s promise to investors to expand its late-stage and commercial portfolio with near-term growth drivers and puts Pfizer at the center of a growing therapeutic area dominated by other big pharma rivals, chiefly AbbVie Inc., Eli Lilly and Company and Amgen,” Jessica Merrill, an analyst at Informa Pharma Intelligence, wrote in a report on the deal. The multibillion-dollar value of the deal compares with the $50 million

Real-world effectiveness after initiating fremanezumab treatment in US patients with episodic and chronic migraine or difficult-to-treat migraine

BackgroundFremanezumab, a fully humanized monoclonal antibody (mAb; IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is approved for the preventive treatment of migraine in adults. The efficacy and safety of fremanezumab for migraine prevention have been demonstrated in randomized, double-blind, placebo-controlled trials. Real-world effectiveness data are needed to complement clinical trial data. This study assessed the effectiveness of fremanezumab across different subgroups of adult patients with episodic migraine (EM), chronic migraine (CM), or difficult-to-treat (DTT) migraine in real-world clinical settings.MethodsThis retrospective, panel-based online chart review used electronic case report forms. Patient inclusion criteria were a physician diagnosis of EM or CM; age ≥ 18 years at the time of first fremanezumab initiation; ≥ 1 dose of fremanezumab treatment; ≥ 1 follow-up visit since first initiation; and ≥ 2 measurements of monthly migraine days (MMD; with 1 within a month before or at first initiation and ≥ 1 after first initiation). Changes in MMD and monthly headache days were assessed during the follow-up period. These endpoints were evaluated in subgroups of patients by migraine type (EM/CM) and in subgroups with DTT migraine (diagnosis of medication overuse [MO], major depressive disorder [MDD], generalized anxiety disorder [GAD], or prior exposure to a different CGRP pathway–targeted mAb [CGRP mAb]).ResultsData were collected from 421 clinicians and 1003 patients. Mean (percent) reductions from baseline in MMD at Month 6 were − 7.7 (77.0%) in EM patients, − 10.1 (68.7%) in CM patients, − 10.8 (80.6%) in the MO subgroup, − 9.9 (68.3%) in the MDD subgroup, − 9.5 (66.4%) in the GAD subgroup, and − 9.0 (68.7%) in the prior CGRP mAb exposure subgroup. Improvements in MDD or GAD severity were reported by 45.5% and 45.8% of patients with comorbid MDD or GAD, respectively.ConclusionsIn this real-world study, fremanezumab demonstrated effectiveness for migraine regardless of migraine type or the presence of factors contributing to DTT migraine (MO, GAD, MDD, or prior exposure to a different CGRP mAb).

Efficacy and tolerability of the ketogenic diet and its variations for preventing migraine in adolescents and adults: a systematic review.

Migraine is a headache of variable intensity that is associated with focal and systemic symptoms. A ketogenic diet (KD), a very-low-carbohydrate diet with a proportional increase in fat, causes brain metabolic alterations, which could be beneficial for some neurologic conditions. A systematic review was conducted to assess the efficacy and tolerability of KD in preventing migraine in adolescents and adults. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses standard was used to review articles found in the PubMed, EMBASE, Scopus, Web of Science, LILACS, LIVIVO, Science Direct, and Cochrane Central Register of Controlled Trials databases. The Google Scholar, DOAJ, ProQuest, and OpenGrey databases were included. The population, intervention, comparison, outcome, and study design strategy included assessing the quality of the evidence using Grading of Recommendations Assessment Development and Evaluation and the risk of bias after applying the JBI critical appraisal tools. Most of the 10 selected studies reported that KD reduced the number and severity of migraine attacks in patients, with few reported adverse effects. The evidence on the effectiveness of the KD is low, so whether the final effect is due to the treatment remains inconclusive. This study represents an initial effort to systematize information on the efficacy and tolerability of KD and its variations in the prevention of migraine. PROSPERO registration no. CRD42020186253.

A real-world study of acute and preventive medication use, adherence, and persistence in patients prescribed fremanezumab in the United States

BackgroundFollowing approval of fremanezumab for the prevention of migraine in adults, health care decision makers are interested in understanding real-world clinical characteristics and treatment patterns among patients initiating fremanezumab therapy.MethodsData were obtained for this retrospective (pre-post) study from the Veradigm Health Insights database. The study period was January 1, 2014, to June 30, 2019. Patients were included if they were aged ≥ 18 years; had ≥ 1 migraine diagnosis during the study period; and had a medication record for fremanezumab on or after diagnosis during the identification period (September 1, 2018–December 31, 2018). Treatment patterns, including adherence, persistence, and utilization of acute and preventive migraine medication prescriptions, were evaluated.ResultsOf 987 patients initiating fremanezumab during the study period, 738 (74.8%) were adherent to fremanezumab by proportion of days covered (PDC; ≥ 80%) and 780 (79.0%) were adherent by medication possession ratio (MPR; ≥ 80%). A total of 746 (75.6%) patients were persistent for ≥ 6 months. Quarterly fremanezumab (n = 186) was associated with higher rates of adherence versus monthly fremanezumab (n = 801) by PDC (quarterly, 91.3%; monthly, 84.9%; P < 0.001) and MPR (quarterly, 92.2%; monthly, 87.9%; P = 0.006) and higher persistence at ≥ 6 months (quarterly, 82.8%; monthly, 73.9%; P = 0.011). After fremanezumab initiation, patients who were persistent for ≥ 6 months experienced significant reductions from baseline in the mean monthly number of acute and preventive migraine medication prescriptions (P < 0.001). Subgroup analyses in patients with comorbid depression and anxiety showed meaningful real-world benefits based on significant reductions in the number of patients who were prescribed antidepressants (baseline, 68.6%; follow-up, 56.4%; P = 0.0025) and anxiolytic medications (baseline, 55.0%; follow-up, 47.2%; P = 0.037), respectively. In a subgroup of patients with comorbid hypertension at baseline, fremanezumab treatment resulted in nonsignificant reductions in blood pressure.ConclusionsOverall, adherence and persistence to fremanezumab in this real-world study was high in patients with migraine, with higher rates observed for quarterly fremanezumab. Patients who were persistent for ≥ 6 months experienced significant reductions in acute and preventive migraine medication use, while a subgroup of migraine patients with comorbid depression and anxiety at baseline showed significant reductions in antidepressant and anxiolytic medication use.

A study of cardiac autonomic functions in patients with chronic migraine versus chronic Tension-type Headache (TTH) in adults cardiac autonomic functions in headache

Objective: To assess cardiac autonomic functions in patients with chronic migraine and chronic tension-type headache (TTH) in adults using heart rate variability (HRV). Methods: Two groups of patients having chronic migraine (n = 25) and chronic TTH (n = 25) were enrolled for this study. HRV was analyzed with the help of BIOPAC MP150. Statistical analysis was performed with SPSS version 21. Unpaired t-test and Mann-Whitney test were used for parameters with normal and nonnormal distribution, respectively. Results: In chronic migraine group, SDNN (38.90 ± 22.14 vs 41.71 ± 20.81 ms, p=1.000), RMSSD (39.20 ± 25.14 vs 64.11 ± 156.74 ms, p=0.437) and pNN50 (13.37 ± 17.94 vs 18.56 ± 20.42, p=0.496) were lower than in chronic THH group. Frequency domain parameters like LF (614.20 ± 604.89 ms2 vs 595.81 ± 597.08 ms2, p=0.823) and HF (1190.68 ± 1330.87 ms vs 832.52 ± 1356.70 ms2, p=0.148 were higher for chronic THH group compared to chronic migraine group. The total power for chronic THH group was higher compared to chronic migraine group (2447.93 ± 2215.03 ms2 vs 1845.27 ± 1550.38 ms2, p=0.308).

Attention deficit hyperactivity disorder and risk of migraine: A nationwide longitudinal study.

This study explored the risk of migraine in children, adolescents, and young adults with attention deficit hyperactivity disorder (ADHD) and its association with ADHD medications. The prevalence of migraine peaks between the ages of 35 and 39years. Recent studies have reported a positive association between ADHD and migraine. This longitudinal case-cohort study was conducted using data from the Taiwan National Health Insurance Database. Between 2001 and 2009, we enrolled 81,441 participants with ADHD and a 1:1-matched control cohort for age, sex, and physical and psychiatric comorbidities. All participants had no diagnosis of migraine before enrollment and were followed up to the end of 2011. We examined the risk of newly diagnosed migraine among patients with ADHD and matched controls after adjusting for demographics and physical/psychiatric comorbidities. Patients with ADHD had a higher incidence of migraine than those in the control group (462/81441 [0.6%] vs. 212/81441 [0.3%] patients, p<0.001). After adjusting for potential confounders, the hazard ratio (HR) was 1.92 (95% CI, 1.64-2.34) for migraine in patients with ADHD versus controls. The subgroup analyses stratified by age showed the HRs were 2.01 (95% CI, 1.63-2.49), 1.94 (95% CI, 1.35-2.79), and 1.31 (95% CI, 0.58-2.98) for children (<12years old), adolescents (12-17), and young adults (18-29), respectively, versus controls. When stratified by sex, the HR was 1.97 (95% CI, 1.58-2.46) for men and 1.94 (95% CI, 1.44-2.62) for women versus controls. The cumulative daily dose of ADHD medications was not associated with the risk of migraine. Children and adolescents with ADHD were associated with an increased risk of migraine compared with matched controls. The increased risk was not observed in young adults with ADHD. Further studies are required to examine the mechanisms between migraine and ADHD.

Real-world effectiveness of fremanezumab in migraine patients initiating treatment in the United States: results from a retrospective chart study

BackgroundThe efficacy and tolerability of fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP) and is approved for the preventive treatment of migraine in adults, have been demonstrated in randomized, double-blind, placebo-controlled trials. Real-world data can further support those clinical trial data and demonstrate the full clinical benefits of fremanezumab. This chart review assessed the effectiveness of fremanezumab for improving clinical outcomes in adult patients with migraine treated according to real-world clinical practice.MethodsThis retrospective, panel-based, online physician chart review study used electronic case report forms with US physicians. Patient inclusion criteria were a physician diagnosis of migraine, fremanezumab treatment initiation at ≥ 18 years of age after US Food and Drug Administration approval, ≥ 1 dose of fremanezumab treatment, and ≥ 2 assessments of monthly migraine days (MMD; 1 within 30 days before treatment initiation and ≥ 1 after initiation). Changes from baseline in MMD, monthly headache days (MHD), and Migraine Disability Assessment (MIDAS) and 6-item Headache Impact Test (HIT-6) scores were assessed over 6 months. These endpoints were evaluated in the overall population and subgroups divided by dosing schedule and number of prior migraine preventive treatment failures.ResultsThis study included data from 421 clinicians and 1003 patients. Mean age at fremanezumab initiation was 39.7 years, and most patients were female (75.8%). In the overall population, mean baseline MMD and MHD were 12.7 and 14.0, respectively. Mean (percent) reductions from baseline in MMD and MHD, respectively, were − 4.6 (36.2%) and − 4.7 (33.6%) at Month 1, − 6.7 (52.8%) and − 6.8 (48.6%) at Month 3, and − 9.2 (72.4%) and − 9.8 (70.0%) at Month 6. Mean (percent) reductions from baseline in MIDAS and HIT-6 scores also increased over the 6-month study period, from − 6.2 (21.6%) and − 8.4 (14.0%) at Month 1 to − 18.1 (63.1%) and − 16.2 (27.0%) at Month 6, respectively. Improvements in these outcomes over 6 months were observed across all evaluated subgroups.ConclusionsThis real-world study demonstrated effectiveness of fremanezumab treatment for up to 6 months, irrespective of dosing regimen or number of prior migraine preventive treatment failures, reflecting ongoing, clinically meaningful improvements in patient outcomes.

Perceived Parental Styles and Alexithymia in Adult Iranian Migraine Patients: The Mediating Role of Emotional Schemas

Migraine, which is a highly prevalent headache, is often comorbid with alexithymia. Parental styles contribute to the development of alexithymia. The core psychological mechanisms that connect parenting to alexithymia and can be targeted in psychotherapy are not yet studied. The objective of this study was to explore the role of emotional schemas as a possible mediator between perceived parental styles and alexithymia in migraine patients. Study participants consisted of 208 (67 males and 141 females) Iranians who completed the Farsi version of Toronto Alexithymia Scale (FTAS-20), Leahy Emotional Schema Scale (LESS II), and Measure of Parental Styles (MOPS) online. For mediation analysis, structural equation modeling was used based on Baron and Kenny’s mediation model. The results demonstrated that mother overprotection and mother indifference were significantly related to alexithymia in migraine patients. Emotional schemas and alexithymia were also positively and significantly related. Additionally, mother overprotection and father indifference showed positive and significant covariation with emotional schemas. Data analysis with structural equation modeling revealed that emotional schemas partially mediate the relationship between parental styles and alexithymia in migraine patients. The current study expands our knowledge of possible mechanisms that relate childhood experiences of being parented and alexithymia in migraine patients. Findings of this research imply psychological treatments can benefit from targeting emotional schemas in migraine patients with alexithymia.

The role of perinatal factors in the development of primary headaches in children

In both children and adult patients, migraine and tension type headache (TTH) are the most common primary headaches, they affect about 15% and 21% of the world’s population, respectively. The role of genetic, psychosocial, hormonal factors is traditionally considered in the genesis of primary headaches. Obviously, neurobiological factors including early brain damage, genetic predisposition are involved in the formation of the pathophysiological basis of primary headaches, which interact with a complex of other factors, including external (psychosocial) factors, leading to changes in the pain mechanisms both at the peripheral and central levels. The literature review presents up-to-date data on the influence of pre- and perinatal factors on the risk of developing primary headaches. Intrauterine growth retardation, smoking and alcohol consumption by mothers during pregnancy are analyzed as risk factors for the development of migraine in children. The connection between the manifestations of increased neuroexcitability in children in the first 6 months with the development of primary headaches in subsequent periods of life is considered. The data of comparison of the results of the assessment of early anamnesis in clinical groups of patients with frequent episodic and chronic TTH are presented. The review examines the possible mechanisms of functional disorders of the nervous system that lead to the occurrence of primary headaches in the future. It is necessary to continue research on the role of perinatal factors in the genesis of primary headaches, to clarify the prognosis regarding the possible chronization of pain syndromes and develop differentiated approaches to the treatment tactics for these patients.

A Markov Analysis of Surgical versus Medical Management of Chronic Migraines.

Refractory chronic migraine is a common and debilitating neurologic condition, affecting over 8 million people in the United States. It is associated with billions of dollars in lost productivity annually. Novel medical (anti-calcitonin gene-related peptide antibodies) and surgical treatment modalities have emerged for chronic migraine in recent years. The current study investigated the cost-utility of surgical versus medical management of refractory chronic migraine. A Markov cohort analysis using hybrid Monte Carlo patient simulation was performed to compare surgical decompression versus erenumab for the treatment of refractory chronic migraine in adults. Both societal and payer perspectives were considered. Primary model outcomes included incremental cost-effectiveness ratio, or cost per quality-adjusted life-year gained. Over a 5-year period, migraine surgery was associated with an increase of 0.2 quality-adjusted life-year per patient when compared to erenumab. In terms of costs, the results demonstrated a $19,337 decrease in direct medical costs and a $491 decrease in indirect costs (productivity lost) for the surgery cohort compared to erenumab. Because surgery improved quality of life and decreased costs compared to erenumab, even when considering revision surgery needs, surgery was the overall dominant treatment in terms of cost-effectiveness. Sensitivity analyses demonstrated that surgery was cost-effective compared to erenumab when patients required therapy for at least 1 year. Surgical deactivation of migraine trigger sites may pose a cost-effective approach to treating refractory chronic migraine in adults. This is especially the case when patients are anticipated to require therapy for more than 1 year.