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 10.17.3 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

Risk factors for relapse in alcohol use disorder

El presente estudio describe la manera en que determinados factores sociodemográficos, características del consumo o distintas modalidades de tratamiento condicionan la recaída en pacientes con diagnóstico de trastorno por uso de alcohol siguiendo los criterios establecidos en el DSM-V. Para ello se emplean datos obtenidos en una población muestral de 110 pacientes incluidos en el Programa de Deshabituación Alcohólica llevado a cabo por el servicio de Psiquiatría del Hospital Universitario “Marqués de Valdecilla” entre Febrero 2001 y Febrero 2008. Se encontró, entre otros datos que: i) el craving constituye el principal factor predictor de recaída, ii) la puntuación basal obtenida en el AUDIT se correlaciona de manera significativa con el riesgo de recaída, iii) la asistencia a grupos de apoyo y un buen apoyo socio-familiar constituyen factores protectores de recaída, iv) no se encuentra significación estadística entre riesgo de recaída y factores sociodemográficos como sexo, estado civil o nivel educativo. Los resultados ponen en evidencia la importancia de la terapia combinada en el tratamiento de los trastornos por consumo de alcohol. Estudios futuros deberán ir dirigidos a implementar estrategias eficaces para combatir el craving en estos pacientes.The present study describes the way in which certain sociodemographic factors, characteristics of the consumption or different treatment modalities influence on relapse in patients with diagnosis of alcohol use disorder following the criteria established in the DSM-V. Data were obtained from a sample population of 110 patients included in the Alcohol Withdrawal Program carried out by the Psychiatric Service of the University Hospital “Marqués de Valdecilla” between February 2001 and February 2008. It was found that: i) craving is the main predictor of relapse, ii) the baseline score obtained in AUDIT correlates significantly with the risk of relapse, iii) assistance to support groups and socio-family support are protective factors for relapse, iv) there is no relationship between risk of relapse and sociodemographic factors such as sex, marital status or educational level. The results highlight the importance of psychotherapy in the treatment of alcohol-related disorders. Future studies should be directed to develop effective strategies against craving in these patients.Grado en Medicin

Treatment of Primary Nummular Headache: A Series of 183 Patients from the NUMITOR Study

Nummular headache (NH) is a primary headache characterized by superficial coin-shaped pain. NUMITOR (NCT 05475769) is an observational study evaluating the responder rate of preventive drugs in NH patients. The treatment response was assessed between weeks 8 and 12 compared with the baseline. Patients were included between February 2002 and October 2022. Demographic and clinical variables were assessed; treatment response was estimated by 50%, 30%, and 75% responder rates and treatment discontinuation due to inadequate tolerability. A total of 183 out of 282 patients fulfilled eligibility criteria and completed the study. Patients were aged 49.5 (standard deviation (SD): 16.8) years, and 60.7% were female. NH phenotype was a parietal circular pain of four centimeters’ diameter, moderate intensity, and oppressive quality. At baseline, patients had 25 (interquartile range) pain days per month. Preventive treatment was used by 114 (62.3%) patients. The highest 50% and 75% responder rates corresponded to onabotulinumtoxinA (62.5%, 47.5%), followed by gabapentin (43.7%, 35.2%). Oral preventive drugs were not tolerated by 12.9–25%. The present study provides class IV evidence of the effectiveness of oral preventive drugs and onabotulinumtoxinA in the treatment of primary NH. OnabotulinumtoxinA was the most effective and best-tolerated drug, positioning it as first-line treatment of NH

sj-pdf-1-cep-10.1177_03331024231201576 - Supplemental material for Long-term outcomes of nummular headache: A series of 168 patients and 1198 patient-years of follow-up

Supplemental material, sj-pdf-1-cep-10.1177_03331024231201576 for Long-term outcomes of nummular headache: A series of 168 patients and 1198 patient-years of follow-up by Cristina García-Iglesias, Ana González-Celestino, Álvaro Sierra Mencía, Yésica González Osorio, Andrea Recio García, Cristina Martínez-Badillo, Ana Echavarría Íñiguez, Berta Varona-Galán, David García-Azorín Ángel Luis Guerrero-Peral in Cephalalgia</p

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

Abstract 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. Graphical Abstrac