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Background The burden of migraine goes beyond the pain and associated symptoms. We aimed to describe the impact of migraine in healthcare resource utilization (HCRU), work productivity, and mood disorders, as well as its economic cost. Methods Case–control study nested in a cross-sectional analysis of patient-reported data collected between 30/12/2019 and 20/04/2020 as part of the National Health and Wellness Survey, from respondents located in Spain. Adults (≥ 18 years old) who reported a physician diagnosis of migraine and ≥ 1 monthly headache days (MHD) in the previous 30 days were included. HCRU, health-related quality-of-life, depression scores, work and activity impairment, and the associated direct and indirect costs were assessed for four cohorts of migraine patients, according to the frequency of headache (MHD: 1–3, 4–7, 8–14, ≥ 15) and compared to a no-migraine control, matched to migraine cases by a propensity score based on demographic and clinical variables. Results The survey was completed by 595 people with active migraine, of whom 461 (77.4%) experienced < 8 MHDs and 134 (22.6%) ≥ 8 MHDs, and 1,190 non-migraine matched controls. Migraine patients presented worse mental and physical health functioning (SF-12 MCS: 41.9 vs. 44.7, p  < 0.001; SF-12 PCS: 48.6 vs. 51.5, p  < 0.001), worse self-reported health (EQ-5D VAS: 65.8 vs. 73.5, p  < 0.001), more severe depression (PHQ-9: 8.9 vs. 6.1, p  < 0.001), and higher overall work impairment (WPAI: 41.4 vs. 25.5, p  < 0.001). People with migraine had higher HCRU, twice higher hospitalization rates (17.0% vs. 8.3%, p  < 0.001) and 1.6 higher emergency room (ER) visit rates (51.4% vs. 31.2%, p  < 0.001). Having migraine translated into higher annual costs with HCRU (€894 vs. €530) and productivity losses (€8,000 vs. €4,780) per person. Respondents with more MHDs presented worse outcomes and higher costs but suffering from 1–3 MHD also increased costs by 51.3%. Conclusions Having migraine not only causes a massive impact on patients’ quality of life and ability to work, but it also generates considerable economic costs for society. In Spain, having migraine was associated to 1.7 higher costs per patient. The clinical and economic burden increases with the frequency of headaches but is higher than controls even in patients suffering from 1–3 MHD. Graphical Abstract

BackgroundErenumab was approved in Europe for migraine prevention in patients with ≥ 4 monthly migraine days (MMDs). In Spain, Novartis started a personalized managed access program, which allowed free access to erenumab before official reimbursement. The Spanish Neurological Society started a prospective registry to evaluate real-world effectiveness and tolerability, and all Spanish headache experts were invited to participate. We present their first results.MethodsPatients fulfilled the ICHD-3 criteria for migraine and had ≥ 4 MMDs. Sociodemographic and clinical data were registered as well as MMDs, monthly headache days, MHDs, prior and concomitant preventive treatment, medication overuse headache (MOH), migraine evolution, adverse events, and patient-reported outcomes (PROs): headache impact test (HIT-6), migraine disability assessment questionnaire (MIDAS), and patient global improvement change (PGIC). A > 50% reduction of MMDs after 12 weeks was considered as a response.ResultsWe included 210 patients (female 86.7%, mean age 46.4 years old) from 22 Spanish hospitals from February 2019 to June 2020. Most patients (89.5%) suffered from chronic migraine with a mean evolution of 8.6 years. MOH was present in 70% of patients, and 17.1% had migraine with aura. Patients had failed a mean of 7.8 preventive treatments at baseline (botulinum toxin type A—BoNT/A—had been used by 95.2% of patients). Most patients (67.6%) started with erenumab 70 mg. Sixty-one percent of patients were also simultaneously taking oral preventive drugs and 27.6% were getting simultaneous BoNT/A. Responder rate was 37.1% and the mean reduction of MMDs and MHDs was -6.28 and -8.6, respectively. Changes in PROs were: MIDAS: -35 points, HIT-6: -11.6 points, PIGC: 4.7 points. Predictors of good response were prior HIT-6 score < 80 points (p = 0.01), ≤ 5 prior preventive treatment failures (p = 0.026), absence of MOH (p = 0.039), and simultaneous BoNT/A treatment (p < 0.001). Twenty percent of patients had an adverse event, but only two of them were severe (0.9%), which led to treatment discontinuation. Mild constipation was the most frequent adverse event (8.1%).ConclusionsIn real-life, in a personalized managed access program, erenumab shows a good effectiveness profile and an excellent tolerability in migraine prevention in our cohort of refractory patients.

In the sustainable development goals (SDG) context of seeking universal health coverage, the expanding gap between the supply of specialized and primary health-care providers of headache-related health care and the care needs of the very large number of people affected by headache is a formidable but not insoluble public-health challenge. Structured headache services provide a cost-effective framework wherein controlled patient flows enable the care needs of people with headache to be met at appropriate levels, but these services may still be overwhelmed by inappropriate demand. Community pharmacists are an underutilized resource, potentially well able to provide the solution. To do so, they must, as a profession, be integrated into structured headache services. What remains to be determined is how to achieve this integration in an encouraging climate for change, which recognises the potential for relieving strained health-care systems and meeting a range of health-care needs by expanding pharmacists’ scope of practice. This position statement on behalf of the European Headache Federation (EHF) and Lifting The Burden (LTB) is formally endorsed by the International Pharmaceutical Federation (FIP).

The trochlear region is a source of distinct pain that may give rise to specific primary pain disorders (primary trochlear headache), but also modulate other pre-existing headache disorders such as migraine. The sensory innervation of this region, by a branch of the ophthalmic division of the trigeminal nerve, may explain the modulatory influence of the nociceptive afferents of this region over migraine headache. We propose the term \"trochlear migraine\" to refer to the coexistence of strictly unilateral migraine and ipsilateral trochleodynia, with the improvement of migraine being dependent on the resolution of the trochleodynia. Trochleitis is an inflammatory trochleodynia, being frequently idiopathic and rarely secondary to usually immunologic and rheumatologic disorders. We postulate that nociceptive afferents from the inner part of the orbit may sustain the activation of trigeminal neurons, thus sensitizing or exacerbating migraine. Decreasing the possible wind-up induced from this nociceptive afferent stimulation may be effective in controlling headache.

IntroductionDespite advances in the management of headache disorders, some patients with migraine do not experience adequate pain relief with acute and preventive treatments. It is the aim of the present document to provide a definition of those migraines which are difficult-to-treat, to create awareness of existence of this group of patients, to help Healthcare Authorities in understanding the implications, and to create a basis to develop a better pathophysiological understanding and to support further therapeutic advances.Main bodyDefinitions were established with a consensus process using the Delphi method.Patients with migraine with or without aura or with chronic migraine can be defined as having resistant migraine and refractory migraine according to previous preventative failures. Resistant migraine is defined by having failed at least 3 classes of migraine preventatives and suffer from at least 8 debilitating headache days per month for at least 3 consecutive months without improvement; definition can be based on review of medical charts. Refractory migraine is defined by having failed all of the available preventatives and suffer from at least 8 debilitating headache days per month for at least 6 consecutive months. Drug failure may include lack of efficacy or lack of tolerability. Debilitating headache is defined as headache causing serious impairment to conduct activities of daily living despite the use of pain-relief drugs with established efficacy at the recommended dose and taken early during the attack; failure of at least two different triptans is required.ConclusionsWe hope, that the updated EHF definition will be able to solve the conflicts that have limited the use of definitions which have been put forward in the past. Only with a widely accepted definition, progresses in difficult-to-treat migraine can be achieved. This new definition has also the aim to increase the understanding of the impact of the migraine as a disease with all of its social, legal and healthcare implications. It is the hope of the EHF Expert Consensus Group that the proposed criteria will stimulate further clinical, scientific and social attention to patients who suffer from migraine which is difficult-to-treat.

Migraine is a disabling primary headache disorder that directly affects more than one billion people worldwide. Despite its widespread prevalence, migraine remains under-diagnosed and under-treated. To support clinical decision-making, we convened a European panel of experts to develop a ten-step approach to the diagnosis and management of migraine. Each step was established by expert consensus and supported by a review of current literature, and the Consensus Statement is endorsed by the European Headache Federation and the European Academy of Neurology. In this Consensus Statement, we introduce typical clinical features, diagnostic criteria and differential diagnoses of migraine. We then emphasize the value of patient centricity and patient education to ensure treatment adherence and satisfaction with care provision. Further, we outline best practices for acute and preventive treatment of migraine in various patient populations, including adults, children and adolescents, pregnant and breastfeeding women, and older people. In addition, we provide recommendations for evaluating treatment response and managing treatment failure. Lastly, we discuss the management of complications and comorbidities as well as the importance of planning long-term follow-up.In this Consensus Statement, which is endorsed by the European Headache Federation and the European Academy of Neurology, an expert panel provides recommendations for the diagnosis and management of migraine to support clinical decision-making by general practitioners, neurologists and headache specialists.

Use of preventive therapy for migraine is often recommended for only 6–9 months, but no randomised, placebo-controlled trials have investigated migraine frequency after the end of prophylaxis. We assessed the effects of discontinuation of topiramate after a treatment period of 6 months. 818 patients who have migraines were enrolled from 88 clinics in 21 countries. After a 4–8-week lead-in period, patients received topiramate in a 26-week open-label phase. Daily dose was increased from 25 mg to 100 mg in steps of 25 mg every week; the dose could be adjusted further in the range 50–200 mg/day, but was stable for the final 4 weeks. Patients were randomly assigned to continue this dose or switch to placebo for a 26-week double-blind phase. The primary endpoint was the difference in number of days with migraine during the last 4 weeks of the double-blind phase compared with the last 4 weeks of the open-label phase. Analysis was by intention to treat. This trial is registered with EudraCT, number 2005-000321-29. 559 patients (68·3%) completed the open-label phase; 514 entered the double-blind phase and were assigned to topiramate (n=255) or placebo (n=259). The mean increase in number of migraine days was greater in the placebo group (1·19 days in 4 weeks, 95% CI 0·71 to 1·66; p<0·0001) than in the topiramate group (0·10, −0·36 to 0·56; p=0·5756; mean difference between groups −1·09, −1·75 to −0·43). Patients in the placebo group had a greater number of days on acute medication than did those in the topiramate group (mean difference between groups −0·95, −1·49 to −0·41; p=0·0007). Quality of life, as assessed by the MIDAS questionnaire, fell in the placebo group but remained stable in the topiramate group. Patients were more satisfied with the efficacy of topiramate than with that of placebo, whereas satisfaction with tolerability was similar in both treatment groups. Sustained benefit was reported after discontinuation of topiramate, although number of migraine days did increase. These findings suggest that patients should be treated for 6 months, with the option to continue to 12 months in some patients.

Lasmiditan, a highly selective 5-hydroxytryptamine receptor 1F (5-HT1F) agonist, is the first drug in its class and is lacking triptan-like vasoactive properties. The US Food and Drug Administration (FDA) has recently approved lasmiditan for the acute treatment of migraine in adults based on positive results of two pivotal phase III trials, which showed a significant difference to placebo in the proportion of patients achieving total migraine freedom within 2 h. More patients with lasmiditan achieved headache freedom and, in addition, freedom from the most bothersome symptom, that is, photophobia, than with placebo. Treatment-related side effects seem to be related to the rapid penetration of the drug into the brain and include dizziness, paresthesia and drowsiness, mostly of mild to moderate intensity. Interim results from an ongoing long-term phase III trial suggest a decrease in the frequency of adverse events after multiple lasmiditan use. Lasmiditan is a promising acute anti-migraine therapy, in particular for patients with cardiovascular risk factors, contraindications, or unwanted side effects to triptans.

Objectives: To analyze the trajectory to diagnosis and information provided in a series of cluster headache (CH) patients from five headache clinics. Methods: CH patients were asked to fill in an ad hoc questionnaire. Results: Seventy-five patients (mean age 41.5 years, 67 males) completed the questionnaire. Patients had visited during an average of 4.9 years a mean of 4.6 physicians who had obtained 2.5 neuroimaging procedures per patient before getting a diagnosis of CH. Sixty-three (84%) had received no diagnosis (21 cases; 28%), while 43 (57%) had been given an average of 2.1 alternative diagnoses. Migraine, trigeminal neuralgia and sinusitis were the most frequent mistakes. After diagnosis, 55% had subjectively received poor/very poor information on CH. Ninety-five percent had poor or incorrect information about the nature of the disease, or acute (70%) and preventive (61%) treatments. Etiology (90%), management options (36%) and potential adverse events of medications (29%) were their main information demands. Conclusions: Although CH is an invalidating and clinically clear-cut disorder suffered by around 1/1,000 people, it is still frequently unrecognized and/or mistaken for other disorders, which calls for a better knowledge and education in the diagnosis of the main primary headaches.