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Background: Real-world studies have shown the sustained therapeutic effect and favourable safety profile of OnabotulinumtoxinA (BoNTA) in the long term and up to 4 years of treatment in chronic migraine (CM). This study aims to assess the safety profile and efficacy of BoNTA in CM after 5 years of treatment in a real-life setting. Methods: We performed a retrospective chart review of patients with CM in relation to BoNTA treatment for more than 5 years in 19 Spanish headache clinics. We excluded patients who discontinued treatment due to lack of efficacy or poor tolerability. Results: 489 patients were included [mean age 49, 82.8% women]. The mean age of onset of migraine was 21.8 years; patients had CM with a mean of 6.4 years (20.8% fulfilled the aura criteria). At baseline, patients reported a mean of 24.7 monthly headache days (MHDs) and 15.7 monthly migraine days (MMDs). In relation to effectiveness, the responder rate was 59.1% and the mean reduction in MMDs was 9.4 days (15.7 to 6.3 days; p < 0.001). The MHDs were also reduced by 14.9 days (24.7 to 9.8 days; p < 0.001). Regarding the side effects, 17.5% experienced neck pain, 17.3% headache, 8.5% eyelid ptosis, 7.5% temporal muscle atrophy and 3.2% trapezius muscle atrophy. Furthermore, after longer-term exposure exceeding 5 years, there were no serious adverse events (AE) or treatment discontinuation because of safety or tolerability issues. Conclusion: Treatment with BoNTA led to sustained reductions in migraine frequency, even after long-term exposure exceeding 5 years, with no evidence of new safety concerns.
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BACKGROUND AND PURPOSE: Anti-calcitonin gene-related peptide (CGRP) therapies are recent preventive therapies approved for both episodic and chronic migraine. One of the measures of effectiveness is the withdrawal of other preventive treatments. The objective of this study is to quantify the impact of anti-CGRP drugs in concomitant preventive treatment in patients with migraine. METHODS: This was an observational, retrospective, multicenter cohort study with patients from nine national headache units. Patients with migraine undergoing treatment for at least 6 months with anti-CGRP antibodies, who were initially associated with some preventive treatment (oral and/or onabotulinumtoxinA) were included. Demographic and clinical variables were collected, as well as variables related to headache. Differences according to withdrawal or nonwithdrawal were evaluated. RESULTS: A total of 408 patients were included, 86.52% women, 48.79 (SD = 1.46) years old. Preventive treatment was withdrawn in 43.87% (179/408), 20.83% partially and 23.04% totally. In 27.45% (112/408), it was maintained exclusively due to comorbidity and in 28.6% (117/408) due to partial efficacy. The most frequent time of withdrawal was between 3 and 5 months after the start of treatment. The baseline characteristics associated with nonwithdrawal were comorbidities: insomnia, hypertension and obesity, chronic migraine, and medication overuse. In the multivariate analysis, the absence of high blood pressure, a greater number of preventive treatments at the start, and a lower number of migraine days/month after anti-CGRP treatment were independently associated with withdrawal of the treatment (p < 0.05). CONCLUSIONS: Anti-CGRP antibodies allow the withdrawal of associated preventive treatment in a significant percentage of patients, which supports its effectiveness in real-life conditions.
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Péptido Relacionado con Gen de Calcitonina , Trastornos Migrañosos , Humanos , Femenino , Lactante , Masculino , Péptido Relacionado con Gen de Calcitonina/uso terapéutico , Estudios Retrospectivos , Estudios de Cohortes , Trastornos Migrañosos/tratamiento farmacológico , Trastornos Migrañosos/prevención & control , CefaleaRESUMEN
OBJECTIVE: To evaluate clinical characteristics, effectiveness, and tolerability of preventive anti- calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) in the elderly. Anti-CGRP mAbs have demonstrated efficacy and safety in patients with migraine although there is limited information regarding the elderly. DESIGN: We performed a multicenter case-control study of cases (patients over 65 years old) and controls (sex-matched patients under 55 years old) with migraine receiving anti-CGRP mAbs. METHODS: We included the demographic characteristics, effectiveness-reduction in the number of monthly headache days (MHD) and monthly migraine days (MMD), 30%, 50%, and 75% responder rates-and treatment emergent adverse events (TEAEs). The primary endpoint was the 50% response rate regarding MHD at weeks 20-24; exploratory 50% response predictors in the elderly were evaluated. RESULTS: In total, 228 patients were included: 114 cases , 114 controls-. Among cases 84.2% (96/114) were women, 79.8% (91/114) CM; mean age of cases 70.1 years old (range: 66-86); mean age of controls was 42.9 years old(range: 38-49). Cases had a higher percentage of vascular risk factors (P < .05),older age of onset (P < .001) and more reported prior preventive treatments (P < .001). Regarding effectiveness in cases, 50% response rate was achieved by 57.5% (42/73) at 20-24 weeks, with lower reduction in the MHD at 8-12 weeks (5 [7.2], 8 [9.1]; P = .001) and a higher reduction in MMD at 20-24 weeks (10.7 [9.1], 9.2 [7.7]; P = .04) compared to the control group. The percentage of TEAEs was similar in the 2 groups. Diagnosis of episodic migraine (EM) (P = .03) and lower number of MHD at baseline (P = .001) were associated with a 50% response in the elderly in univariate analysis. CONCLUSIONS: Our study provides real world evidence of effectiveness and safety of anti-CGRP mAbs for migraine in patients without upper age-limit and possible predictors of anti-CGRP response in the elderly.
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Péptido Relacionado con Gen de Calcitonina , Trastornos Migrañosos , Anciano , Humanos , Femenino , Anciano de 80 o más Años , Adulto , Persona de Mediana Edad , Masculino , Estudios de Casos y Controles , Trastornos Migrañosos/tratamiento farmacológico , Trastornos Migrañosos/prevención & control , Cefalea , Grupos ControlRESUMEN
BACKGROUND: Chronic migraine (CM) causes great disability and affects an individual's quality of life. OnabotulinumtoxinA (OBT-A, Botox®) was the first prophylactic treatment specifically indicated for CM. The aim of this study was to describe the experiences of women with CM treated with OBT-A. MATERIALS AND METHODS: The study design is a qualitative descriptive study. A purposeful sampling of 30 women (mean age, 42.7; standard deviation, 10.6) who had received at least two administrations of OBT-A for CM (PREEMPT protocol) was performed. Data collection included in-depth interviews and researchers' field notes. A thematic analysis was carried out according to qualitative research guidelines. RESULTS: Five themes were identified: (a) A long way to go before Botox®, (b) First time hearing about the treatment and its expectations, (c) The administration of Botox®, (d) Treatment effects, and (e) Follow-up. Patients described a long history of treatment failures prior to the start of OBT-A treatment. Information about this migraine treatment came from the neurologist; following the information, patients had high expectations, including unrealistic expectations regarding the onset and duration of effect. They acknowledged fear of the injections and some discomfort due to the procedure. With treatment, participants reported better migraine control and an improvement in their quality of life. Follow-up had some barriers, such as delayed appointments for subsequent doses, but also strengths, such as effectiveness and few side effects. CONCLUSIONS: Qualitative research offers insight into how patients with CM experience treatment with OBT-A. Our results highlight some relevant aspects that should be considered when providing OBT-A treatment.
Women had unrealistic expectations regarding the onset and duration of OBT-A effect.With OBT-A treatment, women perceived better migraine control and improved quality of life.Follow-up had barriers, such as delayed appointments for subsequent doses.
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Toxinas Botulínicas Tipo A , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Trastornos Migrañosos , Humanos , Femenino , Adulto , Toxinas Botulínicas Tipo A/uso terapéutico , Calidad de Vida , Miedo , Trastornos Migrañosos/tratamiento farmacológicoRESUMEN
BACKGROUND AND PURPOSE: Several variables have been reported to be associated with anti-calcitonin gene-related peptide (CGRP) receptor or ligand antibody response, but with differing results. Our objective was to determine whether machine-learning (ML)-based models can predict 6-, 9- and 12-month responses to anti-CGRP receptor or ligand therapies among migraine patients. METHODS: We performed a multicenter analysis of prospectively collected data from patients with migraine receiving anti-CGRP therapies. Demographic and clinical variables were collected. Response rates in the 30% to 50% range, or at least 30%, in the 50% to 75% range, or at least 50%, and response rate of at least 75% regarding the reduction in the number of headache days per month at 6, 9 and 12 months were calculated. A sequential forward feature selector was used for variable selection and ML-based predictive models for the response to anti-CGRP therapies at 6, 9 and 12 months, with model accuracy not less than 70%, were generated. RESULTS: A total of 712 patients were included, 93% were women, and the mean (SD) age was 48 (11.6) years. Eighty-four percent of patients had chronic migraine. ML-based models using headache days/month, migraine days/month and the Headache Impact Test (HIT-6) yielded predictions with an F1 score range of 0.70-0.97 and an area under the receiver-operating curve score range of 0.87-0.98. SHAP (SHapley Additive exPlanations) summary plots and dependence plots were generated to evaluate the relevance of the factors associated with the prediction of the above-mentioned response rates. CONCLUSIONS: Our results show that ML models can predict anti-CGRP response at 6, 9 and 12 months. This study provides a predictive tool that can be used in a real-world setting.
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Anticuerpos Monoclonales , Antagonistas del Receptor Peptídico Relacionado con el Gen de la Calcitonina , Trastornos Migrañosos , Adulto , Anticuerpos Monoclonales/uso terapéutico , Antagonistas del Receptor Peptídico Relacionado con el Gen de la Calcitonina/uso terapéutico , Femenino , Cefalea , Humanos , Ligandos , Aprendizaje Automático , Masculino , Persona de Mediana Edad , Trastornos Migrañosos/tratamiento farmacológicoRESUMEN
Background Infratrochlear neuralgia is a recently described painful cranial neuropathy that causes pain in the internal angle of the orbit and the medial upper eyelid, the upper bridge of the nose and/or the lacrimal caruncle. We aim to present seven new cases of infratrochlear neuralgia treated with anaesthetic nerve blocks. Methods Over an 18-month period, we prospectively identified seven cases of infratrochlear neuralgia among the patients attending the Headache Unit in a tertiary hospital. Anaesthetic blocks were performed by injecting 0.5 cc of bupivacaine 0.5% at the emergence of the nerve above the internal canthus. Results All patients were women, and the mean age was 49.1 years (standard deviation, 17.9). The pain appeared at the internal angle of the orbit and/or the medial upper eyelid in six cases, and the whole territory of the infratrochlear nerve in one case. Six patients had continuous pain and one had episodes lasting 8-24 hours. All patients showed sensory disturbances within the painful area and tenderness upon palpation of the infratrochlear nerve. Nerve blocks resulted in complete and long-lasting relief in four patients and short-lasting relief in the other three patients. Conclusions Infratrochlear neuralgia should be considered among the neuralgic causes of orbital and periorbital pain. Anaesthetic blocks may assist clinicians in the diagnosis and may also be an effective therapy.
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Neuralgia Facial/cirugía , Bloqueo Nervioso/métodos , Adulto , Anciano , Anciano de 80 o más Años , Anestésicos Locales/uso terapéutico , Bupivacaína/uso terapéutico , Femenino , Humanos , Persona de Mediana Edad , Nervio Troclear/efectos de los fármacosRESUMEN
OBJECTIVE: We aim to report 4 patients with brief pain paroxysms whose clinical features remind of typical epicrania fugax (EF), except for the direction along a transverse trajectory. BACKGROUND: EF has been defined as a brief paroxysmal head pain, with stabbing quality, describing a linear or zig-zag trajectory across the surface of one hemicranium. METHODS: We considered all patients attending the headache outpatient office at 3 tertiary hospitals from March 2008 to December 2015. We identified a total of 4 cases with dynamic pain paroxysms moving in coronal direction. RESULTS: The mean age at onset was 49 years (range 34-75). All the patients suffered a dynamic pain from parietal or temporal areas to the contralateral ones, crossing the midline in a linear or zig zag trajectory, the entire sequence lasting 2-3 seconds. No triggers were identified. One patient noticed mild interictal tenderness at the stemming point. The frequency of the attacks varied from 2 per week to 1 every 2 months. No underlying disorders were identified by physical and neurological exams and neuroimaging and laboratory tests. CONCLUSIONS: Our patients presented with a paroxysmal head pain that might correspond to a transverse variant of EF. These observations may not only expand the EF phenotype but also reinforce the distinction between EF and pericranial neuralgias.
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Cefalea/complicaciones , Umbral del Dolor/fisiología , Dolor/complicaciones , Cuero Cabelludo/fisiopatología , Adulto , Anciano , Femenino , Cefalea/diagnóstico , Humanos , Masculino , Persona de Mediana Edad , Estimulación Física , Estudios Retrospectivos , Centros de Atención Terciaria , Escala Visual AnalógicaRESUMEN
BACKGROUND: Prolonged auras such as those of hemiplegic migraine or migraine with brainstem aura may be extremely disabling. The availability of effective treatments is limited, but two case reports described cessation of the aura symptoms after a greater occipital nerve (GON) blockade. CASE: A 26-year-old woman with a history of hemiplegic migraine with prolonged auras came to our office with an episode of motor and sensory aura 1 hour after onset. Both muscle strength and sensory function started to improve immediately after a GON anesthetic blockade, and the patient was fully relieved in 50 minutes. CONCLUSION: GON blockade may be an effective option for the acute treatment of hemiplegic aura or other prolonged migraine auras.
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Hemiplejía/cirugía , Migraña con Aura/cirugía , Bloqueo Nervioso , Nervios Espinales/cirugía , Adulto , Anestésicos Locales/administración & dosificación , Bupivacaína/administración & dosificación , Femenino , Humanos , Inyecciones , Resultado del TratamientoRESUMEN
INTRODUCTION: Intermittent fever has been occasionally related to migraine, either as a migraine equivalent or as a migraine accompaniment. We present a case of recurrent increase in body temperature consistently associated with migraine headaches. METHODS: A 15-year-old girl reported a 3-year lasting history of migraine without aura, with a feeling of warmth occurring in each episode. Ancillary tests did not show any evidence of secondary headaches or any systemic disease. A 2-month headache diary was obtained, with daily records of headache intensity (0, no headache; 1, mild pain; 2, moderate pain; 3, severe pain) and simultaneous measurements of axillary temperature. Both parameters were registered in the evening, at 6:00 pm every day. The distribution of headache intensity and body temperature as well as the relationship between both variables over time were analyzed with nonparametric tests. RESULTS: The number of days without pain was 28 (45.2%); a mild headache was present on 13 days (21%), a moderate headache on 15 days (24.2%), and a severe headache on 6 days (9.7%). Headache days were associated with higher body temperature than headache-free days (median values: 37.3°C vs 36.6°C; Mann-Whitney U-test, P < 0.001). Moreover, a positive correlation was found between headache intensity and body temperature (Spearman's rho coefficient: 0.83, P < 0.001). CONCLUSIONS: Recurrent increase in body temperature may be another manifestation of the complex clinical spectrum of migraine. This symptom is probably related to hypothalamic involvement.
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Temperatura Corporal/fisiología , Trastornos Migrañosos/fisiopatología , Adolescente , Femenino , Flunarizina/uso terapéutico , Humanos , Hipotálamo/fisiopatología , Registros Médicos , Trastornos Migrañosos/tratamiento farmacológico , Examen Neurológico , Dimensión del Dolor , Vasodilatadores/uso terapéuticoRESUMEN
OBJECTIVE: Epicrania fugax (EF) is a primary headache of recent description. We aimed to report 19 new cases of EF, and thus contribute to the characterization of this emerging headache. BACKGROUND: EF is characterized by painful paroxysms starting in a particular area of the head, and rapidly radiating forwards or backwards through the territories of different nerves. The pain is felt in quick motion along a lineal or zigzag trajectory. To date, 47 cases have been published, 34 with forward EF and 13 with backward EF. METHODS: We performed a descriptive study of all EF cases attending our Headache Unit from April 2010 to December 2012. Demographic and clinical data were recorded with a structured questionnaire. RESULTS: Overall, there were 12 women and 7 men. Mean age at onset was 51.7 ± 16.2. Fourteen patients had forward EF, while 5 patients had backward EF. Painful paroxysms lasted 1-4 seconds. Pain intensity was usually moderate or severe, and pain quality was mostly electric. Four patients had ocular autonomic accompaniments. Pain frequency was extremely variable, and 7 patients identified some triggers. Between attacks, 13 patients had some pain or tenderness in the stemming area. Thirteen patients required therapy for their pain. Neuromodulators, indomethacin, anesthetic blockades, and steroid injections were used in different cases, with partial or complete response. CONCLUSION: EF appears as a distinct headache syndrome and could be eventually included in future editions of the International Classification of Headache Disorders.