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OBJECTIVE: This study was undertaken to evaluate perampanel (PER) when used under real-world conditions to treat people with idiopathic generalized epilepsy (IGE) included in the PERaMpanel pooled analysIs of effecTiveness and tolerability (PERMIT) study. METHODS: The multinational, retrospective, pooled analysis PERMIT explored the use of PER in people with focal and generalized epilepsy treated in clinical practice across 17 countries. This subgroup analysis included PERMIT participants with IGE. Time points for retention and effectiveness measurements were 3, 6, and 12 months (last observation carried forward, defined as "last visit," was also applied to effectiveness). Effectiveness was evaluated by seizure type (total seizures, generalized tonic-clonic seizures [GTCS], myoclonic seizures, absence seizures) and included ≥50% responder rate and seizure freedom rate (defined as no seizures since at least the previous visit). Safety/tolerability was monitored throughout PER treatment and evaluated by documenting the incidence of adverse events (AEs), including psychiatric AEs and those leading to treatment discontinuation. RESULTS: The Full Analysis Set included 544 people with IGE (51.9% women, mean age = 33.3 years, mean epilepsy duration = 18.1 years). At 3, 6, and 12 months, 92.4%, 85.5%, and 77.3% of participants were retained on PER treatment, respectively (Retention Population, n = 497). At the last visit, responder and seizure freedom rates were, respectively, 74.2% and 54.6% (total seizures), 81.2% and 61.5% (GTCS), 85.7% and 66.0% (myoclonic seizures), and 90.5% and 81.0% (absence seizures) (Effectiveness Population, n = 467). AEs occurred in 42.9% of patients and included irritability (9.6%), dizziness/vertigo (9.2%), and somnolence (6.3%) (Tolerability Population, n = 520). Treatment discontinuation due to AEs was 12.4% over 12 months. SIGNIFICANCE: This subgroup analysis of the PERMIT study demonstrated the effectiveness and good tolerability of PER in people with IGE when administered under everyday clinical practice conditions. These findings are in line with clinical trial evidence, supporting PER's use as broad-spectrum antiseizure medication for the treatment of IGE.
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Epilepsias Mioclónicas , Epilepsia Tipo Ausencia , Epilepsia Generalizada , Adulto , Femenino , Humanos , Masculino , Anticonvulsivantes/uso terapéutico , Quimioterapia Combinada , Epilepsias Mioclónicas/tratamiento farmacológico , Epilepsia Tipo Ausencia/tratamiento farmacológico , Epilepsia Generalizada/tratamiento farmacológico , Inmunoglobulina E/uso terapéutico , Piridonas/uso terapéutico , Estudios Retrospectivos , Convulsiones/tratamiento farmacológico , Convulsiones/inducido químicamente , Resultado del TratamientoRESUMEN
PURPOSE: We conducted an observational study to investigate the opinions of neurologists and psychiatrists all around the world who are taking care of patients with seizures [epilepsy and functional seizures (FS)]. METHODS: Practicing neurologists and psychiatrists from around the world were invited to participate in an online survey. On 29th September 2022, an e-mail including a questionnaire was sent to the members of the International Research in Epilepsy (IR-Epil) Consortium. The study was closed on 1st March 2023. The survey, conducted in English, included questions about physicians' opinions about FS and anonymously collected data. RESULTS: In total, 1003 physicians from different regions of the world participated in the study. Both neurologists and psychiatrists identified "seizures" as their preferred term. Overall, the most preferred modifiers for "seizures" were "psychogenic" followed by "functional" by both groups. Most participants (57.9%) considered FS more difficult to treat compared to epilepsy. Both psychological and biological problems were considered as the underlying cause of FS by 61% of the respondents. Psychotherapy was considered the first treatment option for patients with FS (79.9%). CONCLUSION: Our study represents the first large-scale attempt of investigating physicians attitudes and opinions about a condition that is both frequent and clinically important. It shows that there is a broad spectrum of terms used by physicians to refer to FS. It also suggests that the biopsychosocial model has gained its status as a widely used framework to interpret and inform clinical practice on the management of patients.
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Epilepsia , Psiquiatría , Humanos , Neurólogos/psicología , Encuestas y Cuestionarios , Epilepsia/terapia , Epilepsia/etiología , Actitud , Electroencefalografía/efectos adversosRESUMEN
Epilepsy syndromes have been recognized for >50 years, as distinct electroclinical phenotypes with therapeutic and prognostic implications. Nonetheless, no formally accepted International League Against Epilepsy (ILAE) classification of epilepsy syndromes has existed. The ILAE Task Force on Nosology and Definitions was established to reach consensus regarding which entities fulfilled criteria for an epilepsy syndrome and to provide definitions for each syndrome. We defined an epilepsy syndrome as "a characteristic cluster of clinical and electroencephalographic features, often supported by specific etiological findings (structural, genetic, metabolic, immune, and infectious)." The diagnosis of a syndrome in an individual with epilepsy frequently carries prognostic and treatment implications. Syndromes often have age-dependent presentations and a range of specific comorbidities. This paper describes the guiding principles and process for syndrome identification in both children and adults, and the template of clinical data included for each syndrome. We divided syndromes into typical age at onset, and further characterized them based on seizure and epilepsy types and association with developmental and/or epileptic encephalopathy or progressive neurological deterioration. Definitions for each specific syndrome are contained within the corresponding position papers.
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Epilepsia Generalizada , Epilepsia , Síndromes Epilépticos , Electroencefalografía/efectos adversos , Epilepsia/diagnóstico , Epilepsia/etiología , Epilepsia Generalizada/complicaciones , Síndromes Epilépticos/complicaciones , Humanos , Convulsiones/diagnósticoRESUMEN
In 2017, the International League Against Epilepsy (ILAE) Classification of Epilepsies described the "genetic generalized epilepsies" (GGEs), which contained the "idiopathic generalized epilepsies" (IGEs). The goal of this paper is to delineate the four syndromes comprising the IGEs, namely childhood absence epilepsy, juvenile absence epilepsy, juvenile myoclonic epilepsy, and epilepsy with generalized tonic-clonic seizures alone. We provide updated diagnostic criteria for these IGE syndromes determined by the expert consensus opinion of the ILAE's Task Force on Nosology and Definitions (2017-2021) and international external experts outside our Task Force. We incorporate current knowledge from recent advances in genetic, imaging, and electroencephalographic studies, together with current terminology and classification of seizures and epilepsies. Patients that do not fulfill criteria for one of these syndromes, but that have one, or a combination, of the following generalized seizure types: absence, myoclonic, tonic-clonic and myoclonic-tonic-clonic seizures, with 2.5-5.5 Hz generalized spike-wave should be classified as having GGE. Recognizing these four IGE syndromes as a special grouping among the GGEs is helpful, as they carry prognostic and therapeutic implications.
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Epilepsia Tipo Ausencia , Epilepsia Generalizada , Niño , Electroencefalografía , Epilepsia Generalizada/diagnóstico , Epilepsia Generalizada/genética , Humanos , Inmunoglobulina E , Convulsiones , SíndromeRESUMEN
The goal of this paper is to provide updated diagnostic criteria for the epilepsy syndromes that have a variable age of onset, based on expert consensus of the International League Against Epilepsy Nosology and Definitions Taskforce (2017-2021). We use language consistent with current accepted epilepsy and seizure classifications and incorporate knowledge from advances in genetics, electroencephalography, and imaging. Our aim in delineating the epilepsy syndromes that present at a variable age is to aid diagnosis and to guide investigations for etiology and treatments for these patients.
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Epilepsia , Síndromes Epilépticos , Comités Consultivos , Electroencefalografía/efectos adversos , Epilepsia/complicaciones , Epilepsia/diagnóstico , Síndromes Epilépticos/complicaciones , Humanos , Convulsiones/diagnósticoRESUMEN
BACKGROUND: Erenumab is a fully human monoclonal antibody and a highly potent, first-in-class calcitonin gene-related peptide receptor inhibitor approved for migraine prevention in adults. Randomised, placebo-controlled trials show that erenumab treatment results in clinically meaningful responses, including significant reductions in monthly migraine days. Real-world evidence of the effectiveness of erenumab in patients with migraine is accruing, but gaps remain, and findings may vary according to region. We evaluated the usage patterns and effectiveness of erenumab in real-world settings in patients with migraine in the United Arab Emirates (UAE). METHODS: This retrospective, observational real-world study enrolled patients ≥ 18 years with migraine who were prescribed erenumab in the UAE. Data were collected at baseline and Months 1, 3 and 6. The primary study objective was to characterise usage patterns of erenumab in patients with chronic migraine (CM) or episodic migraine (EM) in real-world settings in the UAE. RESULTS: Of the 166 patients, 124 (74.7%) were females. The mean (standard deviation) age at migraine onset was 29 (7.93) years. Seventy-one patients (42.8%) had CM and 95 (57.2%) had EM. In the overall population, the mean monthly headache/migraine days (MHD) at baseline was 15.7 (8.45) and mean change from baseline was - 8.2 (8.83) at Month 1, - 11.0 (9.15) at Month 3 and - 11.3 (8.90) at Month 6. The mean change from baseline in monthly acute migraine-specific medication days (MSMD) was - 9.0 (8.07) at Month 1, - 9.7 (8.73) at Month 3 and - 10.7 (8.95) at Month 6. At all time points, most patients achieved at least 50% reduction in MHD (80%-91%) and MSMD (84%-94%). Similar reductions in MHD and MSMD and clinical benefit in CM or EM were seen with erenumab monotherapy or erenumab add-on therapy, with or without dose escalation and for treatment naïve or ≥ 1 previous preventive treatment failures, with additional clinical benefit in the erenumab add-on therapy and dose escalation to 140 mg subgroups. CONCLUSION: In this real-world study on erenumab use in the UAE, patients prescribed erenumab achieved clinically meaningful reductions in MHD and MSMD at all assessed time points. Erenumab was well tolerated with no new safety events.
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Enfermedad Injerto contra Huésped , Trastornos Migrañosos , Adulto , Anticuerpos Monoclonales Humanizados , Antagonistas del Receptor Peptídico Relacionado con el Gen de la Calcitonina/uso terapéutico , Método Doble Ciego , Femenino , Enfermedad Injerto contra Huésped/tratamiento farmacológico , Humanos , Masculino , Trastornos Migrañosos/tratamiento farmacológico , Trastornos Migrañosos/epidemiología , Trastornos Migrañosos/prevención & control , Estudios Retrospectivos , Resultado del Tratamiento , Emiratos Árabes Unidos/epidemiologíaRESUMEN
OBJECTIVE: To investigate the opinions and attitudes of neurologists on the counseling about sudden unexpected death in epilepsy (SUDEP) worldwide. METHODS: Practicing neurologists from around the world were invited to participate in an online survey. On February 18th, 2021, we emailed an invitation including a questionnaire (using Google-forms) to the lead neurologists from 50 countries. The survey anonymously collected the demographic data of the participants and answers to the questions about their opinions and attitudes toward counseling about SUDEP. RESULTS: In total, 1123 neurologists from 27 countries participated; 41.5% of the respondents reported they discuss the risk of SUDEP with patients and their care-givers only rarely. Specific subgroups of patients who should especially be told about this condition were considered to be those with poor antiseizure medication (ASM) adherence, frequent tonic-clonic seizures, or with drug-resistant epilepsy. The propensity to tell all patients with epilepsy (PWE) about SUDEP was higher among those with epilepsy fellowship. Having an epilepsy fellowship and working in an academic setting were factors associated with a comfortable discussion about SUDEP. There were significant differences between the world regions. CONCLUSION: Neurologists often do not discuss SUDEP with patients and their care-givers. While the results of this study may not be representative of practitioners in each country, it seems that there is a severe dissociation between the clinical significance of SUDEP and the amount of attention that is devoted to this matter in daily practice by many neurologists around the world.
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Muerte Súbita e Inesperada en la Epilepsia , Actitud , Consejo , Muerte Súbita/epidemiología , Muerte Súbita/etiología , Humanos , Neurólogos , Factores de Riesgo , Encuestas y CuestionariosRESUMEN
OBJECTIVES: In this international study, we aimed to investigate the opinions of physicians dealing with patients with functional seizures (FS) worldwide on working restrictions and disability benefits eligibility. METHODS: International online survey of neurologists/mental health professionals from Argentina, Venezuela, Colombia, Italy, France, Iran, Iraq, United Arab Emirates (UAE), Qatar, Saudi Arabia, Georgia, and Russia. RESULTS: Six hundred and twenty-seven physicians from 12 countries participated in the study. Working as a neurologist was a predictor to think that patients with FS should not be counseled to avoid performing all jobs or professions as long as they have active disease (OR: 0.46; 95% CI: 0.30 to 0.68; pâ¯<â¯0.001). Having managed more than 200 patients was associated with the opinion that patients should not be counseled to avoid performing any type of work (OR: 2.17; 95% CI: 1.02 to 4.59; pâ¯=â¯0.043). Working as a psychiatrist/psychologist was associated with the idea that patients with FS should be qualified for disability benefits (OR: 1.97; 95% CI: 1.21-3.21; pâ¯=â¯0.006), and receive these benefits lifelong (OR: 0.43; 95% CI: 0.22-0.84; pâ¯=â¯0.014). CONCLUSION: Neurologists and mental health professionals have different attitudes and opinions toward working restrictions and disability benefits for patients with FS. Further studies should investigate the reasons for these differences, and propose solutions to avoid discrimination and unequal access to employment and disability benefits.
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Médicos , Convulsiones , Argentina , Actitud , Colombia , Francia , Humanos , Irán , Italia , Qatar , Federación de Rusia , Arabia Saudita , Emiratos Árabes UnidosRESUMEN
PURPOSE: To investigate the opinions of physicians on the use of complementary and alternative medicine (CAM) in patients with epilepsy (PWE) worldwide. METHODS: Online survey addressed to neurologists and psychiatrists from different countries. RESULTS: Totally, 1112 physicians from 25 countries (different world region: Europe, North America, South America, Middle-East, Africa, Former Soviet Union Republics) participated; 804 (72.3%) believed that CAM might be helpful in PWE. The most commonly endorsed CAM included meditation (41%) and yoga (39%). Female sex, psychiatry specialization, and working in North and South America were associated with the belief that CAM is helpful in PWE. Two-hundred and forty five out of 1098 participants (22.3%) used/prescribed CAM to PWE; among them, 174 (71%) people perceived CAM to be less effective and 114 (46.5%) people found CAM to be safer than conventional antiseizure medications (ASMs). The most common reasons to prescribe CAM for PWE were: to satisfy the patient (49.9%), dissatisfaction with the efficacy (35.6%), and dissatisfaction with the adverse effects (31.2%) of conventional therapies. CONCLUSION: Although the evidence supporting the use of CAM for the treatment of epilepsy is extremely sparse, most physicians worldwide believe that it could be integrated with the use of conventional ASMs, at least in some patients. High-quality controlled trials are warranted to provide robust evidence on the usefulness of CAM options in PWE.
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Terapias Complementarias , Epilepsia , Médicos , África , Epilepsia/terapia , Europa (Continente) , Femenino , Humanos , Medio Oriente , América del Norte , América del Sur , Encuestas y CuestionariosRESUMEN
PURPOSE: To explore various social aspects of life (i.e., employment, education, and driving) in a large sample of patients with functional seizures (FS) living in seven countries from four continents. METHODS: In this retrospective study, we investigated adult patients with FS, who were admitted to the epilepsy monitoring units at centers in Iran, Qatar, USA, France, Georgia, Egypt, and United Arab Emirates (UAE). We studied the social aspects of life in the whole cohort. Then, we compared the social aspects of life between different world regions. RESULTS: Four hundred and forty patients were included (241 from Iran, 56 from Qatar, 52 from France, 41 from the USA, 19 from UAE, 18 from Egypt, and 13 from Georgia). One hundred and twenty six people (30%) had college education, 142 (33%) were employed, and 101 (28%) drove a motor vehicle in their routine daily lives. People with FS and college education were more likely to report a history of sexual abuse compared with those with a lower education. Patients with no loss of responsiveness with their FS were more likely to be employed. Male patients and patients without aura were more likely to drive a motor vehicle in their routine daily lives. None of the social characteristics of the patients with FS showed significant differences among the two large culturally different groups (Muslim nations vs. Christian nations). CONCLUSION: It appears that patients with FS across cultures have significant problems in their social aspects of life.
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Electroencefalografía , Convulsiones , Adulto , Egipto/epidemiología , Francia/epidemiología , Humanos , Irán , Masculino , Qatar , Estudios Retrospectivos , Convulsiones/epidemiología , Emiratos Árabes UnidosRESUMEN
PURPOSE: The study aimed to investigate the marital status in a cohort of patients with functional seizures from seven countries in four continents. Factors associated with marital status were also explored. METHODS: Adult patients with functional seizures who were admitted to the epilepsy monitoring units at centers in Iran, Qatar, USA, France, Georgia, Egypt, and United Arab Emirates (UAE) were retrospectively identified. Marital status was assessed in the whole cohort. RESULTS: Four hundred thirty-two patients were included (241 from Iran, 52 from France, 48 from Qatar, 41 from the USA, 19 from UAE, 18 from Egypt, and 13 from Georgia); 302 were women and 130 were men. One hundred fifty (35%) subjects were single, 245 (57%) were married, and 37 (8%) were separated (31 divorced, 7%; 6 widowed, 1%). Auras with functional seizures were less frequently reported by single people in comparison with that by married patients (54% vs. 61%) [odds ratio (OR)â¯=â¯0.58]. Separated people compared with those who were married less often had auras with their functional seizures (27% vs. 61%; ORâ¯=â¯0.26) and more often reported a history of sexual abuse (49% vs. 12%; ORâ¯=â¯6.14). CONCLUSION: The marital status has significant associations with the semiology of functional seizures. A history of sexual abuse is significantly associated with being separated and should be inquired and tackled appropriately during the management process of patients with functional seizures.
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Convulsiones , Adulto , Egipto , Femenino , Francia/epidemiología , Humanos , Irán , Masculino , Estado Civil , Qatar , Estudios Retrospectivos , Convulsiones/epidemiología , Emiratos Árabes UnidosRESUMEN
PURPOSE: We conducted a multicenter international cross-cultural comparative study to investigate clinical semiology and predisposing factors of functional seizures in a large cohort of patients living in different countries around the world. We hypothesized that semiology and predisposing factors of functional seizures differ between various world regions. METHODS: We conducted this retrospective observational study in adults with functional seizures admitted to epilepsy centers in Iran, Qatar, USA, France, Georgia, Egypt, and United Arab Emirates (UAE). We assessed and compared the demographic and clinical seizure characteristics of these patients, according to the patients' reports and review of the ictal recordings during video-electroencephalogram (EEG) monitoring. RESULTS: Five hundred nine patients were included (270 from Iran, 74 from Qatar, 63 from France, 43 from the USA, 22 from Egypt, 20 from UAE, and 17 from Georgia). Although all major manifestations of functional seizures (e.g., aura, loss of responsiveness, generalized motor seizures, ictal injury) were seen in all world regions, seizure semiology differed significantly across countries. Auras, ictal urinary incontinence, and ictal injury were more commonly reported by the American patients than patients from other world regions, whereas loss of responsiveness and generalized motor seizures were more frequently observed in the Iranian and American patients than the European and Arab patients. CONCLUSION: Semiology of functional seizures seems to vary across various regions of the world; socioeconomic, cultural, ethnic, and religious differences may play an essential role in the modulation of functional seizures semiology across different nations and cultures.
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Comparación Transcultural , Internacionalidad , Trastornos Psicofisiológicos/etnología , Trastornos Psicofisiológicos/psicología , Convulsiones/etnología , Convulsiones/psicología , Adolescente , Adulto , Anciano , Estudios Transversales , Electroencefalografía/métodos , Electroencefalografía/tendencias , Femenino , Hospitalización/tendencias , Humanos , Masculino , Anamnesis/métodos , Persona de Mediana Edad , Trastornos Psicofisiológicos/fisiopatología , Estudios Retrospectivos , Convulsiones/fisiopatología , Adulto JovenRESUMEN
PURPOSE: Lacosamide (LCM) was recently introduced in the Middle East. The aim of this study was to evaluate the safety, tolerability, and efficacy of LCM in patients with focal onset seizures and determine if our results are comparable with those derived from Western countries. METHODS: This is a retrospective analysis from two medical centers on consecutive patients diagnosed as having focal onset seizures and treated with add-on LCM. The primary efficacy variables were the 50% responder and seizure-free rates, and the secondary outcome variables included the percentages of patients who achieved seizure remission during the last 6-month follow-up period and the percentages of discontinuation due to lack of efficacy or tolerability. RESULTS: One hundred four patients with a mean age of 30.9â¯years and experiencing a mean of 9.4 seizures per month during baseline were included. The 50% responder rates were 69% and 70% at 6- and 24-month follow-ups, respectively. Patients concomitantly treated with a sodium channel blocker were less likely to achieve seizure remission during the last 6-month follow-up period while the early introduction of LCM resulted in a significantly higher likelihood of achieving such a remission. Eighty-eight percent of patients were still maintained on LCM at the last follow-up, and the most common adverse events consisted of dizziness and somnolence, double vision, and nausea/vomiting. CONCLUSIONS: Our data show similar efficacy and tolerability to those reported from Western countries. Our results also substantiate the early introduction of LCM and support the dose reduction of baseline AED especially that of sodium channel blockers to minimize adverse events.
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Anticonvulsivantes/uso terapéutico , Epilepsias Parciales/tratamiento farmacológico , Lacosamida/uso terapéutico , Convulsiones/tratamiento farmacológico , Adolescente , Adulto , Anciano , Anticonvulsivantes/efectos adversos , Niño , Mareo/inducido químicamente , Relación Dosis-Respuesta a Droga , Femenino , Humanos , Lacosamida/efectos adversos , Masculino , Persona de Mediana Edad , Medio Oriente , Vigilancia de Productos Comercializados , Estudios Retrospectivos , Resultado del Tratamiento , Vómitos/inducido químicamente , Adulto JovenRESUMEN
The objective of this study was to examine the relationship between legal status and guardedness in patients who attempted suicide in Abu Dhabi, United Arab Emirates. The consultation-liaison team assessed 355 patients admitted for suicidal/self-injurious behavior, recording their guardedness before knowing whether they were legally charged. Patients who were legally charged for the suicidal act (n = 139) were 1.6 times (p = .03) more guarded in volunteering information than patients who were not legally charged. Legally charging suicide attempters might have a negative impact on risk assessment and psychiatric care.
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Intento de Suicidio/legislación & jurisprudencia , Intento de Suicidio/psicología , Revelación de la Verdad , Adolescente , Adulto , Anciano , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Persona de Mediana Edad , Intento de Suicidio/estadística & datos numéricos , Emiratos Árabes Unidos , Adulto JovenRESUMEN
Depression and anxiety are highly prevalent in patients with epilepsy (PWE), with prevalence rates ranging from 20% to 55%. Unfortunately, the rates, patterns, and risk factors have not been well studied in the Middle East and, to our knowledge, have not been studied at all in the UAE. We screened 186 patients attending an epilepsy clinic using standardized screening tools to determine the rates of both depression and anxiety and compared these rates with that of age- and sex-matched controls. Almost one-third of our patients scored in the depression and anxiety ranges, which was significantly higher compared with the age- and sex-matched controls. Using a multiregression model, none of the studied variables were associated with an increased risk of having either disorder. Depression or anxiety symptoms independently and significantly increased the risk of association with the other disorder. Almost two-thirds of patients with depression and anxiety were not prescribed antidepressant or antianxiety medications.
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Ansiedad/epidemiología , Depresión/epidemiología , Epilepsia/complicaciones , Epilepsia/psicología , Adolescente , Adulto , Anciano , Anticonvulsivantes/uso terapéutico , Ansiedad/etiología , Ansiedad/psicología , Estudios Transversales , Depresión/etiología , Depresión/psicología , Egipto/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Escalas de Valoración Psiquiátrica , Riesgo , Factores de Riesgo , Convulsiones/epidemiología , Factores Socioeconómicos , Encuestas y Cuestionarios , Adulto JovenRESUMEN
Drug-induced seizures are rare causes of hospital admissions (Coleman, 2004). Various classes of drugs are reported to induce seizures either directly, due to their epileptogenic potential or due to drug withdrawal effect, or indirectly, due to systemic and CNS-related side effects (Thundiyil et al., 2011). Midwakh is commonly used among young Emiratis. However, its CNS-related adverse effects are not well studied. We report seven consecutive patients with a history of seizures provoked by smoking midwakh and a negative workup for epilepsy. Six of these patients had no further seizures after they had agreed to discontinue smoking midwakh.
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Convulsiones/inducido químicamente , Fumar/efectos adversos , Adolescente , Adulto , Humanos , Masculino , Emiratos Árabes Unidos , Adulto JovenRESUMEN
INTRODUCTION: The introduction of clacitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) has revolutionized the treatment of migraines. In clinical practice gepants might be considered as a valid option to treat acute attacks in patients with migraine who are treated with mAbs. However, the safety and tolerability of such a combination is not well addressed in the real-world setting. We designed this study to evaluate the safety and tolerability of combining CGRP mAbs with gepants in the management of migraines. METHODS: This was a retrospective, real-world, exploratory study. The participants included within the study were adult (≥ 18 years) patients diagnosed with migraine. Screening for patients who were treated with at least one GCRP mAbs was done. Data was collected from one site, the American Center for Psychiatry and Neurology, Abu Dhabi UAE. A total of 516 patients taking CGRP mAbs were identified. Extracted data from patients' electronic medical records included patient demographics, migraine characteristics, prescribed treatments, and adverse events (AEs). The tolerability and safety of the combination therapy was evaluated on the basis of documented AEs. RESULTS: Among the identified 516 patients, 234 were administered gepants in addition to the CRGP mAb (215, rimegepant; 19, ubrogepant). Eleven of the 234 patients switched from rimegepant to urogepant as a result of lack of efficacy; one patient switched from urogepant to zolmitriptan because of the lack of insurance coverage of the former medication. Among all the patients included in this study, three AEs were documented. These AEs were generally mild and transient and hence did not lead to discontinuation of treatment. Moreover, 42 of the 234 (17.9%) patients were switched from one class of CGRP mAbs to another at least once while continuing treatment with the assigned gepants. CONCLUSION: The findings of this study demonstrate that combining CGRP mAbs with gepants is a safe and well-tolerated treatment approach for migraine. Future studies are warranted to further validate these findings and explore long-term outcomes.
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INTRODUCTION: Migraine, characterized by recurrent headaches and often accompanied by other symptoms like nausea, vomiting, and sensitivity to light and sound, significantly impacts patients' quality of life (QoL) and daily functioning. The global burden of migraines is reflected not only in terms of reduced QoL but also in the form of increased healthcare costs and missed work or school days. While UAE (United Arab Emirates)-specific consensus-based recommendations for the effective use of preventive calcitonin gene-related peptide (CGRP)-based migraine therapies have been published previously, an absence of such regional guidance on the management of acute migraine represents a gap that needs to be urgently addressed. METHODS: A task force of eight neurologists from the UAE with expertise in migraine management conducted a comprehensive literature search and developed a set of expert statements on the management of acute migraine that were specific to the UAE context. To ensure diverse perspectives are considered, a Delphi panel comprising 16 neurologists plus the task force members was set up. Consensus was achieved using a modified Delphi survey method. Consensus was predefined as a median rating of 7 or higher without discordance (if > 25% of the Delphi panelists rate an expert statement as 3 or lower on the Likert scale). Expert statements achieving consensus were adopted. RESULTS: The Modified Delphi method was used successfully to achieve consensus on all nine expert statements drafted by the task force. These consensus statements aim to provide a comprehensive guide for UAE healthcare professionals in treating acute migraine. The statements cover all aspects of acute migraine treatment, including what goals to set, the timing of treatment, treatment strategy to use in case of inadequate response to triptans, safety aspects of combining gepants for acute attacks with preventive CGRP-based therapies, special population (pregnant and pediatric patients) considerations, and the management of the most bothersome symptoms (MBS). CONCLUSIONS: Adopting these consensus statements on the treatment of acute migraine can help enhance patient care, improve outcomes, and standardize treatment practices in the UAE. The collaborative effort of experts with diverse experiences in developing these consensus statements will strengthen the credibility and applicability of these statements to various healthcare settings in the country.
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Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) have shown promising effectiveness in migraine management compared to other preventative treatment options. Many questions remain regarding switching between antibody classes as a treatment option in patients with migraine headaches. This preliminary retrospective real-world study explored the treatment response of patients who switched between CGRP mAb classes due to lack of efficacy or poor tolerability. A total of 53 patients with migraine headache switched between three of the CGRP mAbs types due to lack of efficacy of the original prescribed CGRP mAbs, specifically eptinezumab, erenumab, and galcanezumab. Fremanezumab was not included due to unavailability in the UAE. Galcanezumab and eptinezumab target the CGRP ligand (CGRP/L), while erenumab targets CGRP receptors (CGRP/R). The analysis of efficacy demonstrated that some improvements were seen in both class switch cohorts (CGRP/R to CGRP/L and CGRP/L to CGRP/R). The safety of switching between CGRP classes was well observed, as any adverse events presented before the class switch did not lead to the discontinuation of treatment following the later switch. The findings of this study suggest that switching between different classes of CGRP mAbs is a potentially safe and clinically viable practice that may have some applications for those experiencing side effects on their current CGRP mAb or those witnessing suboptimal response.
RESUMEN
INTRODUCTION: Eptinezumab is a humanized IgG1 immunoglobulin monoclonal antibody administered intravenously as a preventative migraine treatment. Previously conducted randomized, double-blind, placebo-controlled trials exhibited significant reductions in monthly migraine frequency among adults experiencing episodic and chronic migraine. The present study seeks to expand upon the current findings and to evaluate eptinezumab's efficacy as a preventative treatment for chronic and episodic migraine patients in the United Arab Emirates. This study is intended to represent the first real-world evidence and will hopefully serve as a valuable complement to the existing literature on the subject. METHODS: This was a retrospective exploratory study. The participants included within the study were adult (≥ 18 years) patients diagnosed with either episodic or chronic migraine. Patients were categorized according to their history of previous preventative treatment failure. For the final assessment of treatment efficacy, we included only patients with a minimum of 6 months of clinical follow-up data. Patients were assessed at baseline for their monthly migraine frequency and assessed again at months 3 and 6. The primary objective was to evaluate the efficacy of eptinezumab in reducing migraine frequency among chronic and episodic migraine patients. RESULTS: A total of 100 participants were identified, of whom 53 completed the study protocol at month 6. Of the total, 40 (75.47%) were female, 46 (86.79%) were Emirati locals, and 16 (30.19%) were pharmaceutically naïve, having never tried any prior preventative therapy. Additionally, 25 (47.17%) patients met the criteria for chronic migraine (CM), whereas the remaining 28 (52.83%) were diagnosed with episodic migraine (EM). The baseline monthly migraine frequency (MMD) was 12.23 (4.97) days across all participants, 15.56 (3.97) for CM patients, and 9.25 (3.76) for EM patients; by month 6, these frequencies reduced to 3.66 (4.21), 4.76 (5.32), and 2.68 (2.61), respectively. Overall, 58.49% of those enrolled experienced > 75% reduction in MMD frequency by month 6. CONCLUSION: Patients enrolled in this trial experienced clinically significant reductions in MMD by month 6. Eptinezumab was well tolerated and with one AE of significance that led to discontinuation from the study.