Headache Medication Research Articles

Outcome of topiramate in migraine prophylaxis.

A descriptive, prospective hospital-based study was conducted at Ibrahim Malik Hospital, National Center of Neurological Disease and Sciences from October 2018 to May 2019. A comprehensive, structural, close-ended questionnaire was used to collect data on demographics, clinical, risk factors, treatment, side effects, and outcome. This study covered 32 study participants; the mean age was 33±10 years, with a female predominance of 27 (84%). Nearly, half of them 15 (47%) migraine triggered by weather changes, and 13 (41%) had menstruation. About 17 (53%) was suffering from headache more than 24 months and most of them 26 (81%) used over-the-counter medications for acute pain headache. The mean frequency of attacks per month was reduced from 6.1 baselines to 3.2, in the severity means was 6.9 turns to 5. Reduction in frequency of attacks there was significant in both number and severity (P<0.001) with no significant difference in 50 and 100mg doses. Concerning adverse effects, 5 (15.6%) did not complain of any, more than a third 12 (38%) experienced weight loss, 7 (22%) both abdominal/gastrointestinal symptoms and dizziness, 5 (16%) mood changes, 4 (13%) both paresthesia and decreased memory, 3 (9%) both anorexia and sleepiness. Topiramate is effective in reducing headache frequency and reasonably well tolerated in adult Sudanese patients with episodic migraine. This may provide good evidence to support its use in routine clinical management.

Medication overuse headache

Medication overuse headache (MOH) is a secondary headache disorder attributed to overuse of acute headache medications by a person with an underlying headache disorder, usually migraine or tension-type headache. MOH is common among individuals with 15 or more headache days per month. Although MOH is associated with substantial disability and reductions in quality of life, this condition is often under-recognized. As MOH is both preventable and treatable, it warrants greater attention and awareness. The diagnosis of MOH is based on the history and an unremarkable neurological examination, and is made according to the diagnostic criteria of the International Classification of Headache Disorders third edition (ICHD-3). Pathophysiological mechanisms of MOH include altered descending pain modulation, central sensitization and biobehavioural factors. Treatment of MOH includes the use of headache preventive therapies, but essential to success is eliminating the cause, by reducing the frequency of use of acute headache medication, and perhaps withdrawing the overused medication altogether. Appropriate treatment is usually highly effective, leading to reduced headache burden and acute medication consumption.

Functional connectivity of the visual cortex in chronic migraine before and after medication withdrawal therapy

Acute withdrawal of headache medication in chronic migraine patients with medication overuse may lead to a dramatic reduction in headache frequency and severity. However, the brain networks underlying chronic migraine and a favorable response to acute withdrawal are still poorly understood. The goal of the present study was to characterize the pattern of intrinsic magnetic resonance imaging (MRI) functional connectivity (FC) specific to chronic migraine and to identify changes in FC that characterize subjects with CM reverting to less frequent headaches. Subjects with chronic migraine (N = 99) underwent a resting-state functional MRI scan before and after three months of medication withdrawal therapy. In addition, we included four control groups who were scanned once: healthy participants (N = 27), patients with episodic migraine (N = 25), patients with chronic back pain (N = 22), and patients with clinical depression (N = 17). Using dual regression analysis, we compared whole-brain voxel-level functional connectivity with ten well-known resting-state networks between chronic migraine and control groups, and between responders to treatment (≥50 % reduction in monthly headache days) and non-responders (<50 % reduction), before and after treatment. Subjects with chronic migraine showed differences in FC with a number of RS-networks, most of which involved the visual cortex, compared with healthy controls. A comparison with patients with episodic migraine, chronic pain and depression showed differences in the same direction, suggesting that altered patterns of functional connectivity in chronic migraine patients could to some extent be explained by shared symptomatology with other pain, depression, or migraine conditions. A comparison between responders and non-responders indicated that effective withdrawal reduced FC with the visual cortex for responders. Interestingly, responders already differed in functional connectivity of the visual cortex at baseline compared with non-responders. Altogether, we show that chronic migraine and successful medication withdrawal therapy are linked to changes in the functional connectivity of the visual cortex. These neuroimaging findings provide new insights into the pathways underlying migraine chronification and its reversibility.

Chapter 13 - Chronic migraine and medication overuse

Though clearly described as far back as the 17th century, chronic migraine has defied precise categorization and has continued to develop as an important diagnostic concept with significant societal impact. Worldwide prevalence is estimated to be between 1% and 3%, and these patients form a dynamic group cycling between chronic and episodic migraine. Theories of pathogenesis are developing supported by recent imaging and other findings. Of the many determinants of progression to chronic migraine, overuse of acute abortive headache medications may be one of the most important modifiable factors. Treatment strategies, in addition to educational measures, have included various preventive migraine medications such as topiramate, valproate, and onabotulinumtoxinA. CGRP monoclonal antibodies are efficacious for the management of chronic migraine both with and without medication overuse.

Medication-overuse headache: clinical profile and management strategies.

Medication-overuse headache (MOH) is a disabling secondary headache disorder, with challenging consequences for affected patients and health care resources. It is defined as headache that occurs on ≥ 15 days per month in a patient known to have primary headache disorder due to regular overuse of acute or abortive headache medication for more than 3 months. MOH affects 1-2% of the world's population in their productive age. New advances in headache neurosciences and development of new treatment options specific for headache, along with an understanding of the clinical profile and pathophysiological mechanisms of MOH, can help improve patient outcomes and decrease the burden on the health care system. This work will review MOH, identify updated clinical assessments and recent management approaches.

Comparison of efficacy and frequency of akathisia and dystonia between olanzapine, metoclopramide and prochlorperazine in ED headache patients

Study objectiveTo compare the efficacy and frequency of akathisia and dystonia between the dopamine antagonist headache medications olanzapine, metoclopramide and prochlorperazine. MethodsThis was a retrospective observational cohort study of patients presenting to a large urban level one trauma center between 2010 and 2018. Inclusion criteria was age ≥ 18 who presented to the emergency department with a chief complaint of headache who received either olanzapine, metoclopramide or prochlorperazine. The primary outcome was need for rescue medication. Secondary outcomes were receiving medication for either akathisia or dystonia. Logistic regression was used to identify differences between the three cohorts up to 72 h from initial presentation. ResultsThere were 5643 patients who met inclusion criteria. Olanzapine was the most commonly used drug (n = 2994, 53%) followed by prochlorperazine (n = 2100, 37%) and metoclopramide (n = 549, 10%). After adjusting for age and gender, there were no differences in risk for receiving rescue therapy or developing akathisia or dystonia. ConclusionDuring initial ED visit and up to 72 h after receiving olanzapine, metoclopramide or prochlorperazine, we found no difference in risk for requiring rescue medication or developing akathisia or dystonia.

OnabotulinumtoxinA Add-On to Monoclonal Anti-CGRP Antibodies in Treatment-Refractory Chronic Migraine.

We sought to assess the effectiveness of combining dual therapy with onabotulinumtoxinA (BTX) add-on to anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (anti-CGRP MAbs) in treatment-refractory patients with chronic migraine (CM). We retrospectively reviewed the medical files of 19 treatment-refractory patients with CM who had failed to two oral migraine preventatives, at least three consecutive BTX cycles (less than 30% response rate), at least three consecutive sessions with either fremanezumab or erenumab (less than 30% response rate), and were eventually switched to dual therapy with BTX add-on to any of the already-given anti-CGRP MAbs. We then assessed from baseline to each monotherapy or dual intervention predefined efficacy follow-up the changes in the following efficacy outcomes: (i) monthly headache days (MHD), (ii) monthly days with moderate/severe peak headache intensity, and (iii) monthly days with intake of any acute headache medication. Response (50% reduction in MHD) rates, safety, and tolerability were also determined. In the majority of cases (n = 14), dual targeting proved effective and was associated with clinically meaningful improvement in all efficacy variables; 50% response rates (also disability and QOL outcomes) coupled with favorable safety/tolerability. Our results advocate in favor of the view that dual therapy is effective and should be considered in difficult-to-treat CM patients who have failed all available monotherapies.

A phase 3, randomised, placebo-controlled study of erenumab for the prevention of chronic migraine in patients from Asia: the DRAGON study

AbstactBackgroundDRAGON was a phase 3, randomised, double-blind, placebo-controlled study which evaluated the efficacy and safety of erenumab in patients with chronic migraine (CM) from Asia not adequately represented in the global pivotal CM study.MethodsDRAGON study was conducted across 9 Asian countries or regions including mainland China, India, the Republic of Korea, Malaysia, the Philippines, Singapore, Taiwan, Thailand, and Vietnam. Patients (N = 557) with CM (aged 18–65 years) were randomised (1:1) to receive once-monthly subcutaneous erenumab 70 mg or matching placebo for 12 weeks. The primary endpoint was the change in monthly migraine days (MMD) from baseline to the last 4 weeks of the 12-week double-blind treatment phase (DBTP). Secondary endpoints included achievement of ≥ 50% reduction in MMD, change in monthly acute headache medication days, modified migraine disability assessment (mMIDAS), and safety. Study was powered for the primary endpoint of change from baseline in MMD.ResultsAt baseline, the mean (SD) age was 41.7 (± 10.9) years, and 81.5% (n = 454) patients were women. The mean migraine duration was 18.0 (± 11.6) years, and the mean MMD was 19.2 (± 5.4). 97.8% (n = 545) randomised patients completed the DBTP. Overall, demographics and baseline characteristics were balanced between the erenumab and placebo groups except for a slightly higher proportion of women in the placebo group. At Week 12, the adjusted mean change from baseline in MMD was − 8.2 days for erenumab and − 6.6 days for placebo, with a statistically significant difference for erenumab versus placebo (adjusted mean difference vs placebo: − 1.57 [95%CI: − 2.83, − 0.30]; P = 0.015). A greater proportion of patients treated with erenumab achieved ≥ 50% reduction in MMD versus placebo (47.0% vs 36.7%, P = 0.014). At Week 12, greater reductions in monthly acute headache medication days (− 5.34 vs − 4.66) and mMIDAS scores (− 14.67 vs − 12.93) were observed in patients treated with erenumab versus placebo. Safety and tolerability profile of erenumab was comparable to placebo, except the incidence of constipation (8.6% for erenumab vs 3.2% for placebo).ConclusionDRAGON study demonstrated the efficacy and safety of erenumab 70 mg in patients with CM from Asia. No new safety signals were observed during the DBTP compared with the previous trials.Trial registrationNCT03867201

Effects on neuromodulation, acupuncture, and aerobic exercises on migraine and tension-type headache outcomes: A systematic review and meta-analysis.

Headache disorders are common diseases that cause a social burden. This systematic review and meta-analysis aimed to evaluate the effects of various non-pharmacological treatments to address or prevent acute headaches, including neuromodulation, acupuncture, and aerobic exercises in patients with episodic migraine and tension-type headache (TTH). We performed a systematic search of the electronic databases PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure, WANFANG MEDICINE ONLINE, and Chinese Medical Journal database using Stata/SE 14.0 to obtain weighted mean differences (WMDs). The outcomes included monthly headache days, headache intensity, headache duration, days per month of acute medication use, and the Medical Outcomes Study 36-Item Short-Form Health Survey. Of 872 identified articles, 27 were included in the meta-analysis. Neuromodulation was associated with reduced headache days (WMD: -1.274, 95% CI [-1.914, -0.634], P < .001), duration (WMD: -2.2, 95% CI [-3.32, -0.107], P < .001) and medication consumption (WMD: -1.808, 95% CI [-2.546, -1.071], P < .001) in cases of migraine. Acupuncture was associated with the alleviation of headache days (WMD: -0.677, 95% CI [-0.932, -0.422], P < .001) and intensity (WMD: -0.893, 95% CI [-1.573, -0.212], P = .01) in cases of migraine and acute medication use (WMD: -3.29, 95% CI [-4.86, -1.72], P < .001) in cases of TTH. Aerobic exercise was associated with reduced headache duration (WMD: -5.1, 95% CI [-8.97, -1.22], P = .01) in cases of TTH. The risk of bias for included articles was moderate. There is low- and moderate-quality evidence that neuromodulation, acupuncture, and aerobic exercises are associated with attenuated headache symptoms in patients with episodic migraine or TTH. However, high-quality studies are needed to draw more detailed conclusions.

Prevalence, frequency, and disability of migraine headaches and tension headaches among the general population in the Eastern Region of Saudi Arabia

A tension-type headache (TTH) is a recurrent headache that is mild to moderate in intensity, unlike migraine (MH), which is accompanied by crippling effects of nausea, vomiting, photophobia, or phonophobia. TTH is more frequent than migraine, but it is less likely to cause severe pain and physical dysfunction. TTHs account for more lost workdays due to their prevalence. The study aimed to evaluate the prevalence, frequency, and disability of MHs and TTHs among the general population in the Eastern Region of Saudi Arabia. A cross-sectional study was employed using a validated questionnaire. The questionnaire implemented the HARDSHIP algorithm to diagnose MH and TTH and questions to correlate their prevalence to socio-demographic data, measurement of the level of disability, headache management, and treatment effectiveness using the chi-square test. The study reviewed 877 subjects (46.6% males vs. 53.4% females). 52.9% of the participants experienced headaches during the previous three months, and 35.6% experienced headaches recently. The most common type of headache was a probable MH (32.1%), followed by a TTH (26.9%), probable TTH (19.5%), and MH (15%). It was reported that some disability was attributed to 47% of MHs and 26% of TTHs. The most commonly used headache medication was paracetamol (53.5%). This study revealed that TTH and MH are common illnesses in Saudi Arabia's Eastern Region. TTH and MH are correlated with significant individual and social burdens, particularly for MH. Headache sufferers mostly manage their headaches using conventional over-the-counter methods.

Real-world experience with 240 mg of galcanezumab for the preventive treatment of cluster headache

BackgroundGalcanezumab of 300 mg monthly is the FDA approved preventive medication for cluster headache (CH) during the cluster period. Compared to the 120 mg galcanezumab syringe for the treatment of migraines, the 100 mg syringe for CH has globally not been as widely available. The aim of our study was to investigate the preventive efficacy and tolerability of two 120 mg galcanezumab doses for episodic CH in clinical practices.MethodsWe evaluated patients with CH who received at least 1 dose of 240 mg (2 prefilled syringe of 120 mg) of galcanezumab in the 3 university hospitals from February 2020 to September 2021. In the patients with episodic CH, the efficacy and safety data of galcanezumab were analyzed regarding to the presence of the conventional preventive therapy at the timing of therapy of galcanezumab. The data of other subtypes of CH were separately described.ResultsIn 47 patients with episodic CH, galcanezumab was started median 18 days after the onset of current bout (range 1–62 days) and 4 patients (10.8%) received second dose of galcanezumab. The median time to the first occurrence of 100% reduction from baseline in CH attacks per week after galcanezumab therapy was 17 days (25% to 75% quartile range: 5.0 ~ 29.5) in all patients with episodic CH, 15.5 days (3.8 ~ 22.1) in 36 patients with galcanezumab therapy add-on conventional preventive therapy, 21.0 days (12.0 ~ 31.5) in 11 patients started galcanezumab as initial preventive therapy. Among 33 patients with headache diary, the proportion of patients with 50% or more reduction in weekly CH attacks at week 3 from baseline were 78.8%. There was no significant difference in the proportion of patients with a reduction of at least 50% in weekly frequency of CH attacks at week 3 between 24 patients received galcanezumab therapy add-on conventional preventive therapy and 9 patient who received initial galcanezumab therapy. (83.3%, vs 66.7%, p = 0.36). There were no significant differences in proportion of “very much better or “much better” between 36 patients received galcanezumab therapy add-on conventional preventive therapy and 11 patient who received initial GT (86.1%, vs 63.6%, p = 0.18).ConclusionOne 240 mg dose of galcanezumab with/without conventional therapy for the prevention of CH is considered effective and safe in clinical practices, as seen in the clinical trial of galcanezumab.

Pathophysiology of Chronic Migraine: Insights from Recent Neuroimaging Research

Chronic migraine (CM) is a highly disabling primary headache disorder with a substantial impact on patients' quality of life. Episodic migraine (EM) and CM are dynamic states; CM usually evolves from EM alongside increased headache frequency, comorbidities, and medication overuse, supporting the notion that migraine is a spectrum disorder. This narrative review aims to summarize neuroimaging studies to better understand the pathophysiology of CM. Positron emission tomography studies have revealed abnormal energy metabolism and metabolic changes in the dorsal rostral pons in individuals with CM, suggesting that this structure has a key role in the pathophysiology of migraine generation and chronification. Magnetic resonance spectroscopy studies have suggested that thalamocortical pathway dysfunction may contribute to migraine chronification, while functional magnetic resonance imaging studies have highlighted that hypothalamic activity may be involved. Recent evidence highlights functional and structural alterations in cortical and subcortical pain-related brain regions in patients with CM. Whether these functional and structural abnormalities of the brain cause migraine chronification or are a consequence of repeated attacks is still debated. In the future, imaging patterns that predict the transformation from EM to CM should be identified.

Prevalence and risk factors of migraine headache among university students: A cross-sectional study in Lebanon

Background Migraine constitutes a major public health concern since it negatively affects both the quality of life and the productivity of patients. Migraine among students can cause impaired academic performance and limit their daily activities. Objective This study aims to assess the prevalence of migraine among university students using the ID Migraine screening tool and to evaluate risk factors associated with migraine. Methods A cross-sectional study was performed over a period of six months targeting 1144 university students recruited from the different faculties. Results Migraine was suggested in 35.8% of subjects based on ID-Migraine. Migraine prevalence was significantly higher among women (42% versus 23.3% of men). After adjusting for covariates, women, daily coffee consumption, having unorganized meals, eating fast food and fasting were the main predictors of migraine. Almost 41% of migraine students had a family history of migraine and only 26.7% sought medical help. Interestingly, most of the migraine students (84.8%) took headache medications without referring them to their doctor. Conclusion Recognizing headache risk factors among migraine students and adopting lifestyle changes accordingly can be an effective strategy to prevent the chronification of the attacks, decrease headache frequency and improve patients’ quality of life.

Quantity changes in acute headache medication use among patients with chronic migraine treated with eptinezumab: subanalysis of the PROMISE-2 study

BackgroundPatients with chronic migraine (CM) treated with eptinezumab in the PROMISE-2 trial achieved greater reductions in migraine and headache frequency, impact, and acute headache medication (AHM) use than did patients who received placebo. This post hoc analysis examines relationships between headache frequency reductions and changes in AHM use in patients in PROMISE-2.MethodsPROMISE-2 was a double-blind, placebo-controlled trial conducted in adults with CM. Patients were randomized to eptinezumab 100 mg, 300 mg, or placebo, administered intravenously once every 12 weeks for up to two doses. Patients recorded headache/AHM information daily and for each event in an electronic diary; data from all days with daily reports were included. Shifts in headache frequency and AHM use were assessed in the three populations: total CM population, patients with CM and medication-overuse headache (MOH), and patients with CM and MOH who were ≥ 50% responders during treatment (response over weeks 1–24).ResultsA total of 1072 adults with CM received treatment (eptinezumab, n = 706; placebo, n = 366). Mean baseline headache frequency was 20.5 days; mean baseline AHM days was 13.4; 431 patients had MOH, of which 225 (52.2%) experienced ≥50% response over weeks 1–24. Relative to baseline, the proportion of days with both headache and AHM use decreased 25.1% (eptinezumab) versus 17.0% (placebo) in the total population (N = 1072), 29.2% versus 18.4% in the MOH subpopulation (n = 431), and 38.3% versus 31.5% in the CM with MOH population with ≥50% response subgroup (n = 225) during weeks 1–24. The proportion of days with headache and triptan use decreased 9.1% (eptinezumab) versus 5.8% (placebo), 11.8% versus 7.2%, and 14.5% versus 12.6%, respectively. Reductions in other AHM types were smaller.ConclusionsIn this post hoc analysis, eptinezumab use in patients with CM was associated with greater decreases in days with headache with AHM overall and with triptans in particular. The magnitude of effect was greater in the subgroup of CM patients with MOH and ≥ 50% response.Trial registrationClinicalTrials.gov Identifier: NCT02974153.Graphical abstractEptinezumab reduces headache frequency and acute medication use in patients with chronic migraine.

Management of medication overuse (MO) and medication overuse headache (MOH) S1 guideline

IntroductionChronic headache due to the overuse of medication for the treatment of migraine attacks has a prevalence of 0.5–2.0%. This guideline provides guidance for the management of medication overuse (MO) and medication overuse headache (MOH).RecommendationsTreatment of headache due to overuse of analgesics or specific migraine medications involves several stages. Patients with medication overuse (MO) or medication overuse headache (MOH) should be educated about the relationship between frequent use of symptomatic headache medication and the transition from episodic to chronic migraine (chronification), with the aim of reducing and limiting the use of acute medication. In a second step, migraine prophylaxis should be initiated in patients with migraine and overuse of analgesics or specific migraine drugs. Topiramate, onabotulinumtoxinA and the monoclonal antibodies against CGRP or the CGRP-receptor are effective in patients with chronic migraine and medication overuse. In patients with tension-type headache, prophylaxis is performed with amitriptyline. Drug prophylaxis should be supplemented by non-drug interventions. For patients in whom education and prophylactic medication are not effective, pausing acute medication is recommended. This treatment can be performed in an outpatient, day hospital or inpatient setting. Patients with headache due to overuse of opioids should undergo inpatient withdrawal. The success rate of the stepped treatment approach is 50–70% after 6 to 12 months. A high relapse rate is observed in patients with opioid overuse. Tricyclic antidepressants, neuroleptics (antiemetics) and the administration of steroids are recommended for the treatment of withdrawal symptoms or headaches during the medication pause. Consistent patient education and further close monitoring reduce the risk of relapse.

The Association of the First Surge of the COVID-19 Pandemic with the High- and Low-Value Outpatient Care Delivered to Adults in the USA.

BackgroundThe first surge of the COVID-19 pandemic entirely altered healthcare delivery. Whether this also altered the receipt of high- and low-value care is unknown.ObjectiveTo test the association between the April through June 2020 surge of COVID-19 and various high- and low-value care measures to determine how the delivery of care changed.DesignDifference in differences analysis, examining the difference in quality measures between the April through June 2020 surge quarter and the January through March 2020 quarter with the same 2 quarters’ difference the year prior.ParticipantsAdults in the MarketScan® Commercial Database and Medicare Supplemental Database.Main MeasuresFifteen low-value and 16 high-value quality measures aggregated into 8 clinical quality composites (4 of these low-value).Key ResultsWe analyzed 9,352,569 adults. Mean age was 44 years (SD, 15.03), 52% were female, and 75% were employed. Receipt of nearly every type of low-value care decreased during the surge. For example, low-value cancer screening decreased 0.86% (95% CI, −1.03 to −0.69). Use of opioid medications for back and neck pain (DiD +0.94 [95% CI, +0.82 to +1.07]) and use of opioid medications for headache (DiD +0.38 [95% CI, 0.07 to 0.69]) were the only two measures to increase. Nearly all high-value care measures also decreased. For example, high-value diabetes care decreased 9.75% (95% CI, −10.79 to −8.71).ConclusionsThe first COVID-19 surge was associated with receipt of less low-value care and substantially less high-value care for most measures, with the notable exception of increases in low-value opioid use.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11606-022-07757-1.

Headache, Opiate Use, and Prescribing Trends in Women With Idiopathic Intracranial Hypertension: A Population-Based Matched Cohort Study.

Physician prescribing habits for opiates and headache therapies have not been previously evaluated in a large, matched cohort study in idiopathic intracranial hypertension (IIH). Our objective was to evaluate opiate and headache medication prescribing habits in women with IIH compared with matched women with migraine and population controls. We also investigated the occurrence of new onset headache in IIH compared with population controls. We performed a population-based matched, retrospective cohort study to explore headache outcomes. Cross-sectional analyses were used to describe medication prescribing patterns. We used data from IQVIA Medical Research Data, an anonymized, nationally representative primary care electronic medical record database in the United Kingdom, from January 1, 1995, to September 25, 2019. Women aged 16 years and older were eligible for inclusion. Women with IIH (exposure) were matched by age and body mass index with up to 10 control women without IIH but with migraine (migraine controls), and without IIH or migraine (population controls). A total of 3,411 women with IIH, 13,966 migraine controls, and 33,495 population controls were included. The adjusted hazard ratio for new onset headache in IIH compared with population controls was 3.09 (95% CI 2.78-3.43). In the first year after diagnosis, 58% of women with IIH were prescribed acetazolamide and 20% topiramate. In total, 20% of women with IIH were prescribed opiates within the first year of their diagnosis, reducing to 17% after 6 years, compared with 8% and 11% among those with migraine, respectively. Twice as many women with IIH were prescribed opiates compared with migraine controls, and 3 times as many women with IIH were prescribed opiates compared with population controls. Women with IIH were also prescribed more headache preventative medications compared with migraine controls. Women with IIH were more likely to be prescribed opiate and simple analgesics compared with both migraine and population controls. Women with IIH trialed more preventative medications over their disease course suggesting that headaches in IIH may be more refractory to treatment.

Reductions in acute medication use and healthcare resource utilization in patients with chronic migraine: a secondary analysis of a phase 3, randomized, double-blind, placebo-controlled study of galcanezumab with open-label extension (REGAIN)

Aims To analyze secondary objectives of the REGAIN study related to acute headache medication use and healthcare resource utilization (HCRU) in patients with chronic migraine treated with galcanezumab, a monoclonal antibody to calcitonin gene-related peptide. Methods Adults with chronic migraine (N = 1,113) were randomized (2:1:1) and treated with double-blind monthly injections of placebo, galcanezumab-120 mg, or galcanenzumab-240 mg for 3 months, followed by a 9-month open-label extension with 120 or 240 mg/month galcanezumab. Headache and medication information was collected by daily eDiary. HCRU was reported for the 6 months before randomization, monthly thereafter, and converted to rate per 100-patient-years. Results At baseline, 63–64% of patients met criteria for acute headache medication overuse. At Month 3, incidence of headache medication overuse in the galcanezumab groups (33% and 33%) was significantly lower than in the placebo group (46%, both p < .001) and was 16% and 23% in the previous-galcanezumab groups at Month 12. From a baseline of 14.5 to 15.5, reduction in mean number of monthly migraine headache days with acute headache medication use was also significantly greater in the galcanezumab groups at Month 3 (−4.2 and −4.9) than in placebo (−2.6, both p < .001), with reductions of −6.8 and −7.6 in the previous-galcanezumab groups at Month 12. Migraine-specific HCRU rates decreased for all groups, with no significant between-group differences at Month 3. At Month 12, in the two previous-galcanezumab groups, emergency room visits decreased by 58% and 75%, hospital admissions by 100%, and healthcare professional visits by 54% and 67%. Limitations Only 3 months of double-blind, placebo-controlled data, a longer HCRU recall period for baseline than postbaseline, and patients receiving care in the clinical trial itself, may limit generalizability. Conclusions Treatment with galcanezumab resulted in significant reductions in headache medication overuse and migraine headache days requiring acute medication use, with notable reductions in migraine-specific HCRU.

The headache registry of the German Migraine and Headache Society (DMKG): baseline data of the first 1,351 patients

BackgroundAlthough good treatment options exist for many headache disorders, not all patients benefit and disability continues to be large. To design strategies for improving headache care, real-world data observing standard care is necessary. Therefore, the German Migraine and Headache Society (DMKG) has established the DMKG Headache Registry. Here we present methods and baseline data.MethodsAccredited German headache centers (clinic-based or private practice) can offer participation to their patients. Patients provide headache history, current headache load (including a mobile headache diary), medication and comorbidities and answer validated questionnaires, prior to their physician appointment. Physicians use these data as the base of their history taking, and add, change or confirm some central information. Before the next visit, patients are asked to update their data. Patients will continuously be included over the next years.ResultsThe present analysis is based on the first 1,351 patients (1110 females, 39.6 ± 12.9 years) with a completed first visit. Most participants had a migraine diagnosis. Participants had 14.4 ± 8.5 headache days and 7.7 ± 6.1 acute medication days per month and 63.9% had a migraine disability assessment (MIDAS) grade 4 (severe disability). 93.6% used at least one acute headache medication, most frequently a triptan (60.0%) or non-opioid analgesic (58.3%). 45.0% used at least one headache preventive medication, most frequently an antidepressant (11.4%, mostly amitriptyline 8.4%) or a CGRP(receptor) antibody (9.8%). Most common causes for discontinuation of preventive medication were lack of effect (54.2%) and side effects (43.3%).ConclusionThe DMKG Headache Registry allows to continuously monitor headache care at German headache centers in both a cross-sectional and a longitudinal approach.Trial registrationThe DMKG Headache Registry is registered with the German Clinical Trials Register (DRKS 00021081).

A Comprehensive Review of Zavegepant as Abortive Treatment for Migraine.

Migraine headache is a widespread and complex neurobiological disorder that is characterized by unilateral headaches that are often accompanied by photophobia and phonophobia. Migraine is one of the leading chief complaints in the emergency department with negative impacts on quality of life and activities of daily living. The high number of emergency presentations also results in a significant economic burden. Its risk factors include family history, genetics, sex, race, socioeconomics, the existence of comorbid conditions, and level of education. Triggers include stress, light, noise, menstruation, weather, changes in sleep pattern, hunger, dehydration, dietary factors, odors, and alcohol. The International Headache Society has defined criteria for the diagnosis of migraine with and without aura. The pathophysiology of migraine headaches is multifactorial so there are a variety of treatment approaches. The current treatment approach includes abortive medications and prophylactic medications. Abortive medications include the first-line treatment of triptans, followed by ergot alkaloids, and calcitonin gene-related peptide (CGRP) receptor antagonists along with supplemental caffeine and antiemetics. Trigeminal afferents from the trigeminal ganglion innervate most cranial tissues and many areas of the head and face. These trigeminal afferents express certain biomarkers such as calcitonin gene-related peptide (CGRP), substance P, neurokinin A, and pituitary adenylate cyclase-activating polypeptide that are important to the pain and sensory aspect of migraines. In this comprehensive review, we discuss Zavegepant, a calcitonin gene-related peptide receptor antagonist, as a new abortive medication for migraine headaches.