RE-START: Exploring the effectiveness of anti-calcitonin gene-related peptide resumption after discontinuation in migraine.

BACKGROUND AND PURPOSE: According to the latest European guidelines, discontinuation of monoclonal antibodies against calcitonin gene-related peptide (anti-CGRP MAb) may be considered after 12-18 months of treatment. However, some patients may worsen after discontinuation. In this study, we assessed the response following treatment resumption. METHODS: This was a prospective study conducted in 14 Headache Units in Spain. We included patients with response to anti-CGRP MAb with clinical worsening after withdrawal and resumption of treatment. Numbers of monthly migraine days (MMD) and monthly headache days (MHD) were obtained at four time points: before starting anti-CGRP MAb (T-baseline); last month of first treatment period (T-suspension); month of restart due to worsening (T-worsening); and 3 months after resumption (T-reintroduction). The response rate to resumption was calculated. Possible differences among periods were analysed according to MMD and MHD. RESULTS: A total of 360 patients, 82% women, with a median (interquartile range [IQR]) age at migraine onset of 18 (12) years. The median (IQR) MHD at T-baseline was 20 (13) and MMD was 5 (6); at T-suspension, the median (IQR) MHD was 5 (6) and MMD was 4 (5); at T-worsening, the median (IQR) MHD was 16 (13) and MMD was 12 (6); and at T-reintroduction, the median (IQR) MHD was 8 (8) and MHD was 5 (5). In the second period of treatment, a 50% response rate was achieved by 57.4% of patients in MHD and 65.8% in MMD. Multivariate models showed significant differences in MHD between the third month after reintroduction and last month before suspension of first treatment period (p < 0.001). CONCLUSION: The results suggest that anti-CGRP MAb therapy is effective after reintroduction. However, 3 months after resumption, one third of the sample reached the same improvement as after the first treatment period.

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.

Oral lacosamide for the treatment of refractory trigeminal neuralgia: A retrospective analysis of 86 cases.

BACKGROUND AND OBJECTIVES: First-line treatment for trigeminal neuralgia (TN) is limited to carbamazepine and oxcarbazepine, and in refractory cases, alternatives are scarce. Lacosamide has been suggested as a valid option. In this study, we describe a series of patients who received oral lacosamide as treatment for TN after first-line drug failure. METHODS: In this retrospective descriptive cohort study, we included patients with refractory TN who attended a tertiary center between 2015 and 2021 and were prescribed oral lacosamide after first-line treatment failure. The primary endpoints were pain relief and adverse effects. We secondarily analyzed clinical outcomes and compared responders versus nonresponders in the search for potential predictors of response. RESULTS: Eighty-six patients were included (mean age: 62 [SD 15.6] years; 54/86 [63%] female). The TN etiology was secondary in 16/86 (19%) patients. Concomitant continuous pain was present in 29/86 (34%) patients. The mean number of previous treatments was 2.7 [SD 1.5]. Pain relief was achieved in 57/86 (66%) cases, with 28/86 (33%) patients presenting adverse effects, all of which were mild. No statistically significant differences were observed between responders and nonresponders, but subtle clinical differences suggested potential predictors of response. CONCLUSION: Lacosamide may be an effective and relatively safe treatment for refractory pain in TN patients after first-line treatment failure.

Intravenous lacosamide and phenytoin for the treatment of acute exacerbations of trigeminal neuralgia: A retrospective analysis of 144 cases.

BACKGROUND: Scant evidence is available on the use of intravenous pain treatment in acute exacerbations of trigeminal neuralgia. The aim of this descriptive study was to evaluate the effectiveness and security of intravenous lacosamide and phenytoin in the treatment of acute trigeminal neuralgia pain. METHODS: We reviewed patients who attended the emergency department of a tertiary hospital between 2012 and 2020 for exacerbations of trigeminal neuralgia pain and were treated with either intravenous phenytoin or lacosamide for the first time. Primary endpoints were pain relief and adverse effects during the hospital stay. A comparative analysis between both treatment groups was performed. RESULTS: We studied 144 episodes in 121 patients (median age 61 years, 66.1% women). Trigeminal neuralgia etiology was secondary in 9.9%. Pain relief was observed in 77.8% of 63 patients receiving lacosamide infusions, and adverse effects in 1.6%. Pain relief was observed in 72.8% of 81 phenytoin infusions and adverse effects in 12.3%, all mild. No difference was observed in pain relief between groups, but the proportion of adverse effects was significantly different (p = 0.023). Statistically significant differences were also detected in readmissions within six months, time to readmission, and pain relief status at first follow-up visit. CONCLUSION: Intravenous lacosamide and phenytoin can be effective and safe treatments for acute pain in trigeminal neuralgia. According to our series, lacosamide might be better tolerated than phenytoin and lead to lower readmissions and sustained pain relief.

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)

Estudio comparativo de grupos independientes de pacientes con migraña episódica tratados preventivamente con flunaricina o nadolol / A study to compare independent groups of patients with episodic migraine who were treated preventively with flunarizine or nadolol

Introducción. La flunaricina, con nivel de evidencia A, y el nadolol, con nivel de evidencia C, estarían indicados como tratamiento preventivo de la migraña. No existen estudios previos que comparen la efectividad de ambos fármacos. Objetivo. Comparar parámetros de efectividad en grupos independientes de pacientes tratados preventivamente con uno de los fármacos del estudio a los que se aplicó el mismo protocolo. Pacientes y métodos. Se seleccionó a pacientes con migraña episódica (criterios de la Sociedad Internacional de Cefaleas del 2004) que se habían sometido a tratamiento preventivo por primera vez, con flunaricina (5 mg/día) o nadolol (20-40 mg/día). Se analizaron las variables principales de efectividad (reducción del número de crisis al cuarto mes de tratamiento y tasa de respondedores). Resultados. Se incluyó a 227 pacientes con intención de recibir tratamiento: 155 con flunaricina (80,5% mujeres; edad media: 38,3 ± 12,1 años) y 72 con nadolol (63,8% mujeres; edad media: 37,1 ± 12,0 años). La media de crisis en el mes previo al tratamiento fue de 6,09 ± 2,6 en el grupo de la flunaricina y de 5,1 ± 1,7 en el grupo del nadolol (p = 0,0079); la media de crisis al cuarto mes de tratamiento fue de 2,61 ± 2,4 en el grupo de la flunaricina y de 2,77 ± 2,4 en el grupo del nadolol (p = NS). Porcentaje de reducción de migrañas: 55,2% con flunaricina y 50,4% con nadolol (p = NS). La tasa de respondedores fue del 69% con flunaricina y del 67% con nadolol (p = NS). La tasa de respuesta excelente (reducción mayor o igual al 75% de las crisis) fue del 52,2% con flunaricina y del 36,1% con nadolol (p = 0,0077). Porcentaje de efectos adversos: 48,3% con flunaricina frente a 25% con nadolol (p = 0,0009). La tasa de satisfacción fue del 68%, similar en ambos grupos. Conclusión. Tanto la flunaricina como el nadolol mostraron ser efectivos en el tratamiento preventivo de la migraña episódica. La flunaricina se utilizó con mayor frecuencia en nuestro medio y fue peor tolerada (AU)

Introduction. Flunarizine, with level of evidence A, and nadolol, with evidence level C, would be indicated as preventive treatment of migraine. Yet, no previous studies have been conducted to compare the effectiveness of the two drugs. Aim. To compare the effectiveness parameters in independent groups of patients treated preventively with one of the pharmaceuticals from the study, the same protocol being applied in both cases. Patients and methods. The subjects selected for the study were patients with episodic migraine (according to 2004 International Headache Society criteria) who had undergone preventive treatment for the first time, with flunarizine (5 mg/day) or nadolol (20-40 mg/day). The main effectiveness variables (reduction in the number of seizures at four months of treatment and responder rates) were analysed. Results. The study included 227 patients who intended to receive treatment: 155 with flunarizine (80.5% females; mean age: 38.3 ± 12.1 years) and 72 with nadolol (63.8% females; mean age: 37.1 ± 12.0 years). The mean number of seizures prior to treatment was 6.09 ± 2.6 in the flunarizine group and 5.1 ± 1.7 in the nadolol group (p = 0.0079); at four months of treatment it was 2.61 ± 2.4 in the flunarizine group and 2.77 ± 2.4 in the nadolol group (p = NS). Percentage of reduction of migraines: 55.2% with flunarizine and 50.4% with nadolol (p = NS). The responder rate was 69% with flunarizine and 67% with nadolol (p = NS). The excellent response rate (reduction in the number of seizures by 75% or more) was 52.2% with flunarizine and 36.1% with nadolol (p = 0.0077). Percentage of adverse side effects: 48.3% with flunarizine and 25% with nadolol (p = 0.0009). The satisfaction rate was similar in both groups, 68%. Conclusions. Both flunarizine and nadolol proved to be effective in the preventive treatment of episodic migraine. Flunarizine is used more often in our milieu and was less well tolerated (AU)

[Comparative study of the effectiveness of topiramate and nadolol in the preventive treatment of episodic migraine in independent series of patients]. / Estudio comparativo de la efectividad del topiramato y del nadolol en el tratamiento preventivo de la migraña episodica en series independientes de pacientes.

INTRODUCTION: Topiramate and nadolol with levels A and C of scientific evidence, respectively, would be indicated as preventive treatments of migraine. To date only one study of satisfaction has been carried out to compare the two pharmaceuticals. AIM: To compare the effectiveness parameters in independent groups of patients treated preventively with one of the pharmaceuticals from the study. PATIENTS AND METHODS: From a database of 700 patients with migraine, those with episodic migraine and who had followed a course of preventive treatment, for the first time, with topiramate or nadolol were selected for the study. The effectiveness variables (reduction in the number of crises at four months of preventive treatment and responder rates) were analysed. RESULTS: Altogether 208 patients with were included for treatment: 140 with topiramate (77.8% females; mean age, 37.9) and 68 with nadolol (69% females; mean age, 36.9). The mean number of crises in the month prior to treatment was: topiramate group, 6.3 +/- 2.6; nadolol group 5.3 +/- 2.0 (p = 0.0066). At four months after starting treatment: topiramate group, 2.69 +/- 2.6; nadolol group 2.6 +/- 2.2 (NS). The percentage of reduction in the number of migraines was 56.6% with topiramate and 51.6% with nadolol (NS). The responder rate (reduction in the frequency of crises by at least 50%) was 71.3% with topiramate versus 69% with nadolol (NS). The excellent response rate (reduction in crises by at least 75%) was 53.3% with topiramate versus 32.2% with nadolol (p = 0.0077). Adverse side effects were reported by 54% of patients treated with topiramate versus 30.8% of those treated with nadolol (p = 0.0015). The rate of satisfaction was 61% for the topiramate group and 71% for the group with nadolol (NS). CONCLUSIONS: Both topiramate and nadolol proved to be effective in the preventive treatment of episodic migraine. Topiramate was found to be more effective than nadolol, although it was used in patients with a higher frequency of crises, and was not tolerated so well.