Observational Retrospective Study in Patients Treated with Galcanezumab as Preventive Treatment for Migraine: The ORYGAM Study.

INTRODUCTION: The efficacy of galcanezumab has been demonstrated in randomized controlled trials, but evidence about its use under clinical practice conditions is still limited. This study aimed to describe the characteristics of the patients treated with galcanezumab in routine clinical practice in Spain as well as treatment patterns, persistence, and effectiveness. METHODS: A retrospective chart review study was carried out in six hospitals. Information of adults with migraine, who started treatment with galcanezumab between November 2019 and September 2021, was analyzed until end or loss of follow-up. Continuous variables were described as mean (standard deviation, SD) and median (interquartile range, IQR), and categorical variables as frequency and percentages. Persistence to treatment was estimated using Kaplan-Meier analysis. RESULTS: A total of 314 patients were analyzed over median follow-up period of 17.5 months (13.8-20.7), with a mean age of 46.3 (12.6), 85% women, 80.6% chronic migraine, and reporting a mean of monthly migraine days of 16.7 (7.8). Overall, 72.9% had comorbid conditions, with anxiety and depression disorders being the most frequent. More than 60% had received ≥ 6 previous preventive drugs, the most common being antiepileptics, antidepressants, and botulinum toxin (95.2%, 89.8% and 84.1%, respectively). Overall, 60.3% of the patients with other preventive treatments maintained them after galcanezumab initiation. The median time on galcanezumab was 14.6 months (9.4-22.8); 95.7%, 82.0%, 76.2% and 59.8% of patients were persistent to treatment at 3, 6, 9 and 12 months, respectively. Of the patients who discontinued (151: 48.1%), 57.6% were due to lack of effectiveness and 31.1% were due to improvement in migraine. The average reduction of monthly migraine days at 3, 6, 9 and 12 months was 7.9 (7.2), 9.1 (7.5), 8.8 (6.6) and 9.0 (6.9) days, respectively. CONCLUSIONS: In real clinical practice, galcanezumab is an effective treatment and has a high persistence in patients with migraine, mostly chronic and with multiple use of previous preventive treatments.

Nueva era terapéutica para el ataque de migraña con los recientemente aprobados anticuerpos monoclonales, ditanes y gepantes / New therapeutic era for migraine attacks with recently approved monoclonal antibodies, ditans and gepants

El tratamiento de los ataques de migraña se aconseja en todos los pacientes, utilizando antiinflamatorios no esteroideos cuando el dolor es leve y triptanes cuando la intensidad del dolor es moderada-grave. Sin embargo, la efectividad de estos fármacos es modesta, un porcentaje elevado de pacientes presenta efectos secundarios y los triptanes están contraindicados en las personas con antecedentes de ictus, cardiopatía isquémica o hipertensión mal controlada. Por tanto, es imprescindible disponer de nuevas alternativas terapéuticas. En los últimos años han ido apareciendo nuevos fármacos para los ataques de migraña, entre los que destacan los ditanes (lasmiditán) y los gepantes (ubrogepant y rimegepant). Por otro lado, el eptinezumab, que ha sido aprobado para el tratamiento preventivo de la migraña en adultos, se ha utilizado también para los ataques de migraña. En este manuscrito se revisan los resultados de eficacia y seguridad de los nuevos fármacos para los ataques de migraña que se comercializarán próximamente. (AU)

Treatment of migraine attacks is advised in all patients, using non-steroidal anti-inflammatory drugs when the pain is mild and triptans when the pain intensity is moderate-severe. However, the effectiveness of these drugs is moderate, a high percentage of patients have side effects, and triptans are contraindicated in people with a history of stroke, ischaemic heart disease or poorly controlled hypertension. Hence, there is an urgent need for new therapeutic alternatives. In recent years, new drugs for migraine attacks have become available, most notably ditans (lasmiditan) and gepants (ubrogepant and rimegepant). Furthermore, eptinezumab, which has been approved for the preventive treatment of migraine in adults, has also been used for migraine attacks. This manuscript reviews the efficacy and safety results of the new drugs for migraines that will soon be on the market. (AU)

Effectiveness and safety of anti-CGRP monoclonal antibodies in patients over 65 years: a real-life multicentre analysis of 162 patients.

BACKGROUND: Anti-CGRP monoclonal antibodies have shown notable effectiveness and tolerability in migraine patients; however, data on their use in elderly patients is still lacking, as clinical trials have implicit age restrictions and real-world evidence is scarce. In this study, we aimed to describe the safety and effectiveness of erenumab, galcanezumab and fremanezumab in migraine patients over 65 years old in real-life. METHODS: In this observational real-life study, a retrospective analysis of prospectively collected data from 18 different headache units in Spain was performed. Migraine patients who started treatment with any anti-CGRP monoclonal antibody after the age of 65 years were included. Primary endpoints were reduction in monthly migraine days after 6 months of treatment and the presence of adverse effects. Secondary endpoints were reductions in headache and medication intake frequencies by months 3 and 6, response rates, changes in patient-reported outcomes and reasons for discontinuation. As a subanalysis, reduction in monthly migraine days and proportion of adverse effects were also compared among the three monoclonal antibodies. RESULTS: A total of 162 patients were included, median age 68 years (range 65-87), 74.1% women. 42% had dyslipidaemia, 40.3% hypertension, 8% diabetes, and 6.2% previous cardiovascular ischaemic disease. The reduction in monthly migraine days at month 6 was 10.1 ± 7.3 days. A total of 25.3% of patients presented adverse effects, all of them mild, with only two cases of blood pressure increase. Headache and medication intake frequencies were significantly reduced, and patient-reported outcomes were improved. The proportions of responders were 68%, 57%, 33% and 9% for reductions in monthly migraine days ≥ 30%, ≥ 50%, ≥ 75% and 100%, respectively. A total of 72.8% of patients continued with the treatment after 6 months. The reduction in migraine days was similar for the different anti-CGRP treatments, but fewer adverse effects were detected with fremanezumab (7.7%). CONCLUSIONS: Anti-CGRP mAbs are safe and effective treatments in migraine patients over 65 years old in real-life clinical practice.

[The myth of tension-type headache]. / El mito de la cefalea tensional.

Tension-type headache is an entity recognised by the International Headache Society in its International Headache Classification. The limits of this condition, however, are somewhat fuzzy and poorly defined, and its diagnostic criteria are a sort of negation of the symptoms of migraine. In this review we are especially interested in highlighting the diagnostic vagueness in patients with chronic tension-type headache. This refers, above all, to those with a clear history of migraine and who continue to suffer a number of crises with symptoms of migraine, although they have headaches with tension-type features on a daily basis. Emphasis will be placed on the novel concept of chronic migraine which, today, can include these patients, and has not only diagnostic but also, and above all, therapeutic implications. Tension-type headache is a clinical syndrome that probably covers a series of entities with important aetiopathogenic differences from one to another and, perhaps sometime in the future, many patients who are now labelled as having been diagnosed with this condition will be classified further as having other better-defined diseases. In any case, although it might sound like a myth or just pie-in-the-sky, the tension-type headache is still needed to encompass these entities that are lacking any better-defined diagnoses.

TITLE: El mito de la cefalea tensional.La cefalea tensional es una entidad reconocida por la Sociedad Internacional de Cefaleas en su Clasificacion Internacional de Cefaleas. Sin embargo, los limites de dicha entidad quedan muy difusos y mal definidos en ella, y sus criterios diagnosticos son una suerte de negacion de los sintomas de la migraña. En la presente revision nos interesa especialmente resaltar la vaguedad diagnostica de los pacientes con cefalea tensional cronica. Sobre todo, de aquellos con antecedentes claros de migraña y que siguen sufriendo algunas crisis con sintomas migrañosos, aunque tengan cefalea de caracteristicas tensionales a diario. Haremos hincapie en el nuevo concepto de migraña cronica que, en la actualidad, permite acoger en su seno a estos pacientes, con implicaciones no solo diagnosticas, sino, sobre todo, terapeuticas. La cefalea tensional es probablemente un sindrome clinico que abarca una serie de entidades con grandes diferencias etiopatogenicas entre ellas y, quizas en un futuro, muchos pacientes que ahora son etiquetados con este diagnostico sean desgranados en distintas enfermedades mejor definidas. De todos modos, aunque suene a mito o entelequia, la cefalea tensional es aun necesaria para englobar a estas entidades huerfanas de diagnosticos mejor definidos.

Factors associated with the differences in migraine prevalence rates between Spanish regions.

We have analyzed the relation of prevalence rates in Spanish regions with a series of human, environmental, and ecological factors. We find that the variability in migraine rates found between Spanish regions may be explained by interregional differences in the percentage of daily smokers, percentage of alcohol consumers, percentage of population presenting physical and/or psychological life-limiting conditions, percentage of population engaging in physical exercise, minimum absolute temperatures per year, number of days under 0 °C per year, and altitude.

El mito de la cefalea tensional / The myth of tension-type headache

La cefalea tensional es una entidad reconocida por la Sociedad Internacional de Cefaleas en su Clasificación Internacional de Cefaleas. Sin embargo, los límites de dicha entidad quedan muy difusos y mal definidos en ella, y sus criterios diagnósticos son una suerte de negación de los síntomas de la migraña. En la presente revisión nos interesa especialmente resaltar la vaguedad diagnóstica de los pacientes con cefalea tensional crónica. Sobre todo, de aquéllos con antecedentes claros de migraña y que siguen sufriendo algunas crisis con síntomas migrañosos, aunque tengan cefalea de características tensionales a diario. Haremos hincapié en el nuevo concepto de migraña crónica que, en la actualidad, permite acoger en su seno a estos pacientes, con implicaciones no sólo diagnósticas, sino, sobre todo, terapéuticas. La cefalea tensional es probablemente un síndrome clínico que abarca una serie de entidades con grandes diferencias etiopatogénicas entre ellas y, quizás en un futuro, muchos pacientes que ahora son etiquetados con este diagnóstico sean desgranados en distintas enfermedades mejor definidas. De todos modos, aunque suene a mito o entelequia, la cefalea tensional es aún necesaria para englobar a estas entidades huérfanas de diagnósticos mejor definidos (AU)

Tension-type headache is an entity recognised by the International Headache Society in its International Headache Classification. The limits of this condition, however, are somewhat fuzzy and poorly defined, and its diagnostic criteria are a sort of negation of the symptoms of migraine. In this review we are especially interested in highlighting the diagnostic vagueness in patients with chronic tension-type headache. This refers, above all, to those with a clear history of migraine and who continue to suffer a number of crises with symptoms of migraine, although they have headaches with tension-type features on a daily basis. Emphasis will be placed on the novel concept of chronic migraine which, today, can include these patients, and has not only diagnostic but also, and above all, therapeutic implications. Tension-type headache is a clinical syndrome that probably covers a series of entities with important aetiopathogenic differences from one to another and, perhaps sometime in the future, many patients who are now labelled as having been diagnosed with this condition will be classified further as having other better-defined diseases. In any case, although it might sound like a myth or just pie-in-the-sky, the tension-type headache is still needed to encompass these entities that are lacking any better-defined diagnoses (AU)

Los triptanes en la práctica clínica: eficacia, tolerancia y satisfacción del paciente con los fármacos (estudio TRIPRACLI) / Triptans in clinical practice: effectiveness, tolerance and patient’s satisfaction with medication (TRIPRACLI study)

Introducción y objetivos. Conocer en nuestro medio la eficacia, tolerabilidad y satisfacción del paciente migrañoso con diferentes triptanes en función de las características de sus crisis e intentar establecer un modelo predictivo para recomendar uno u otro en función de dichas características. Pacientes y métodos. Estudio retrospectivo observacional multicéntrico en unidades de cefalea. Se incluyen pacientes con migraña que utilizan un mismo triptán para el tratamiento de sus crisis. Se analizan datos de preferencia, eficacia, rapidez y tolerancia. Resultados. Se analizan 160 pacientes (88 mujeres), con una edad media de 42,92 años. Los triptanes más utilizados fueron eletriptán, almotriptán y rizatriptán. Tanto pacientes como médicos mostraron un alto grado de satisfacción (88% y 65%, respectivamente) con el triptán utilizado. En las encuestas de preferencia, los pacientes preferían el triptán actual sobre el previo (83%) o fármacos no específicos (93%). La valoración global en una escala analógica visual estuvo por encima de 7 para todos los triptanes, sin diferencias entre ellos. Al analizar la utilización de un determinado triptán en función de las características de las crisis, no se encontraron diferencias estadísticamente significativas. Conclusiones. En este grupo seleccionado de pacientes, los triptanes son un tratamiento por el que los pacientes muestran un alto grado de satisfacción. Aunque no existen diferencias globales en las puntuaciones entre los diferentes triptanes, el hecho de que determinados triptanes sean más utilizados por los pacientes después de experiencias previas con otros sugiere una mayor eficacia por su parte. No hemos encontrado ningún parámetro que prediga la utilización de un determinado triptán(AU)

Introduction and aims. This study was aimed determining the effectiveness, tolerance and satisfaction of patients with migraine as regards different triptans, according to the characteristics of their attacks. At the same time it sought to establish a predictive model that can be used to recommend one or another, depending on those characteristics. Patients and methods. Retrospective observation-based study conducted in headache units in a number of different centres. Patients included in the study were those with migraine who used the same triptan to treat their attacks. Data concerning preference, effectiveness, speed and tolerance were analysed. Results. The analysis included 160 patients (88 females), with a mean age of 42.92 years. The most commonly used triptans were eletriptan, almotriptan and rizatriptan. Both patients and doctors reported a high degree of satisfaction (88% and 65%) with the triptan that was used. In the surveys on preference, patients preferred their current triptan to the previous one (83%) or to non-specific drugs. The overall score on a visual analogue scale was above 7 for all the triptans, without any differences from one to another. On analysing the use of a particular triptan depending on the characteristics of the attacks, no statistically significant differences were found. Conclusions. In this selected group of patients, triptans are a treatment that patients claim to be very satisfied with. Although there are no overall differences in the scores among different triptans, the fact that certain triptans are used more by patients after previous experiences with others suggests that they are more effective. We did not find any parameter that predicts the use of a particular triptan(AU)

Improved patient satisfaction and pain evolution with almotriptan in migraine: a primary care study.

BACKGROUND/OBJECTIVE: The START study was a large general practice observational study involving 400 patients with migraine. Given the large sample size, a sub-analysis was planned to ascertain whether any patient characteristics/behaviors might help predict/explain the responses observed in this study, which demonstrated that almotriptan administered early when pain was mild significantly improved pain-related outcomes compared with non-early/non-mild treatment. METHODS: This pre-planned sub-analysis assessed the impact of predictors of patient satisfaction, medication history, delayed drug intake, etc. on the primary pain endpoints of the START study. RESULTS: Patients had previously tried an average of 2.5 drugs for migraine relief and were currently taking a mean of 1.4 drugs. Almotriptan had been tried by 21% of the sample and was still being used by 83% of this sub-group. Treatment satisfaction was higher in the subset of patients taking almotriptan than in almotriptan-naїve individuals (p < 0.001) and this may explain why this group had the highest continuation rate of all drugs evaluated. On completion of the study, patient satisfaction was higher in the early/mild treatment group than the non-early/non-mild group (p = 0.049). Many patients delayed taking almotriptan, despite being instructed otherwise. Patients reported that this was primarily because they believed that they should only take the medication in the case of a severe migraine attack and/or to ensure that the symptoms were definitely due to migraine headache. The limitations of the trial include its open, observational design, and the small number of individuals who managed to treat their migraine attack within 1 hour when it was still mild. CONCLUSIONS: Almotriptan was associated with increased patient satisfaction, particularly when taken early. Further action is required to increase patient compliance with early treatment regimens to improve clinical outcomes.

One-year prevalence of migraine in Spain: a nationwide population-based survey.

AIM: The purpose of the study was to estimate the one-year prevalence of migraine among a population-based sample of Spanish adults. METHOD: Men and women aged 18-65 years were selected at random according to quotas for age, sex, size of habitat (<10,000 inhabitants, 10,001-50,000 inhabitants, 50,001-200,000 inhabitants and >200,000 inhabitants) and residence proportional to the population size of the geographical location. A random-digit-dial, computer-assisted telephone interview (CATI) survey was conducted between April and July 2006. The 2004 International Headache Society operational diagnostic criteria were applied. RESULTS: From a total of 70,692 telephone calls and 26,255 (31.7%) valid contacts, 5,668 (21.6%) respondents completed the CATI survey. A total of 476 subjects (8.4%, 95% confidence interval [CI] 7.7-9.1%) with strict migraine and 236 with probable migraine (4.2%, 95% CI 3.7-4.7%) were recorded. The 1-year prevalence of total migraine (N = 712) was 12.6% (95% CI 11.6-13.6) (17.2% in females, 8.0% in males). The prevalence rates showed significant geographic variations, from 7.6% in Navarra to 18% in the Canary Islands. One-half of the subjects had migraine with aura. One-third of subjects were never diagnosed for migraine. CONCLUSIONS: The one-year prevalence of migraine in Spain is 12.6%, with a prevalence of migraine with and without aura of 8.4% and probable migraine of 4.2%. These findings add data to the current understanding of migraine.