Immunohistochemical evaluation of fibrin/fibrinogen, d-dimers, and intravascular thrombosis in brains of dogs with meningoencephalitis of unknown origin.

Granulomatous meningoencephalitis (GME) and necrotizing encephalitides (NE) are the most common immune-mediated inflammatory diseases of the central nervous system in dogs. Activation of the fibrinolytic system in multiple sclerosis, a similar immune-mediated disease affecting the central nervous system in humans, seems to be related to disease progression. The aim of this study was to identify fibrin/fibrinogen and D-dimer deposition, as well as presence of intravascular thrombosis (IVT) in brains of dogs with a diagnosis of GME or NE. Immunohistochemical studies using antibodies against fibrin/fibrinogen and D-dimers were performed. Statistical analyses were performed to determine whether there were differences in the presence and location of fibrin/fibrinogen, D-dimers deposits, and IVT between GME and NE. Samples from sixty-four dogs were included in the study: 32 with a diagnosis of GME and 32 with a diagnosis of NE. Fibrin/fibrinogen depositions were detected in all samples and d-dimers were detected in 43/64 samples. IVT was present in 29/64 samples, with a significantly higher score in samples from dogs with NE than in samples from dogs with GME (P = 0.001). These data support hemostatic system activation in both diseases, especially NE. This finding might be related to the origin of the necrotic lesions seen in NE, which could represent chronic ischemic lesions. Further studies are needed to investigate the association between vascular lesions and the histopathological differences between GME and NE and the hemostatic system as a potential therapeutic target.

Predictive factors of six-week mortality in critically ill patients with SARS-CoV-2: A multicenter prospective study.

OBJECTIVE: The objective of the study is to identify the risk factors associated with mortality at six weeks, especially by analyzing the role of antivirals and munomodulators. DESIGN: Prospective descriptive multicenter cohort study. SETTING: 26 Intensive care units (ICU) from Andalusian region in Spain. PATIENTS OR PARTICIPANTS: Consecutive critically ill patients with confirmed SARS-CoV-2 infection were included from March 8 to May 30. INTERVENTIONS: None. VARIABLES: Variables analyzed were demographic, severity scores and clinical condition. Support therapy, drug and mortality were analyzed. An univariate followed by multivariate Cox regression with propensity score analysis was applied. RESULTS: 495 patients were enrolled, but 73 of them were excluded for incomplete data. Thus, 422 patients were included in the final analysis. Median age was 63 years and 305 (72.3%) were men. ICU mortality: 144/422 34%; 14 days mortality: 81/422 (19.2%); 28 days mortality: 121/422 (28.7%); 6-week mortality 152/422 36.5%. By multivariable Cox proportional analysis, factors independently associated with 42-day mortality were age, APACHE II score, SOFA score at ICU admission >6, Lactate dehydrogenase at ICU admission >470U/L, Use of vasopressors, extrarenal depuration, %lymphocytes 72h post-ICU admission <6.5%, and thrombocytopenia whereas the use of lopinavir/ritonavir was a protective factor. CONCLUSION: Age, APACHE II, SOFA>value of 6 points, along with vasopressor requirements or renal replacement therapy have been identified as predictor factors of mortality at six weeks. Administration of corticosteroids showed no benefits in mortality, as did treatment with tocilizumab. Lopinavir/ritonavir administration is identified as a protective factor.

Predictive factors of six-week mortality in critically ill patients with SARS-CoV-2: A multicenter prospective study / Factores predictivos de la mortalidad a las seis semanas en pacientes críticos con SARS-CoV-2: estudio multicéntrico prospectivo

Objective: The objective of the study is to identify the risk factors associated with mortality at six weeks, especially by analyzing the role of antivirals and munomodulators. Design: Prospective descriptive multicenter cohort study. Setting: 26 Intensive care units (ICU) from Andalusian region in Spain. Patients or participants: Consecutive critically ill patients with confirmed SARS-CoV-2 infection were included from March 8 to May 30. Interventions: None. Variables: Variables analyzed were demographic, severity scores and clinical condition. Support therapy, drug and mortality were analyzed. An univariate followed by multivariate Cox regression with propensity score analysis was applied. Results: 495 patients were enrolled, but 73 of them were excluded for incomplete data. Thus, 422 patients were included in the final analysis. Median age was 63 years and 305 (72.3%) were men. ICU mortality: 144/422 34%; 14 days mortality: 81/422 (19.2%); 28 days mortality: 121/422 (28.7%); 6-week mortality 152/422 36.5%. By multivariable Cox proportional analysis, factors independently associated with 42-day mortality were age, APACHE II score, SOFA score at ICU admission >6, Lactate dehydrogenase at ICU admission >470U/L, Use of vasopressors, extrarenal depuration, %lymphocytes 72h post-ICU admission <6.5%, and thrombocytopenia whereas the use of lopinavir/ritonavir was a protective factor. Conclusion: Age, APACHE II, SOFA>value of 6 points, along with vasopressor requirements or renal replacement therapy have been identified as predictor factors of mortality at six weeks. Administration of corticosteroids showed no benefits in mortality, as did treatment with tocilizumab. Lopinavir/ritonavir administration is identified as a protective factor (AU)

Objetivo: Identificar los factores de riesgo asociados con la mortalidad a las seis semanas. Diseño: Estudio prospectivo multicéntrico. Ámbito: Se incluyeron a 26 pacientes de la Unidad de Cuidados Intensivos (UCI) de Andalucía. Pacientes o participantes: Pacientes ingresados en UCI por neumonía grave por SARS-CoV-2 del 8 de marzo al 30 de mayo de 2020. Intervenciones: Ninguna. Variables de interés principales: Características demográficas, clínicas y escalas de gravedad. Se analizaron tratamientos de soporte, fármacos y la mortalidad. Resultados: Se incluyeron 495 pacientes, 73 fueron excluidos por incompletos y 422 pacientes se incorporaron en el análisis final. La mediana de edad fue de 63 años, 305 (72,3%) eran hombres. La mortalidad en la UCI fue: 144/422 34%; mortalidad a los 14 días: 81/422 (19,2%); mortalidad a los 28 días: 121/422 (28,7%); mortalidad a las seis semanas 152/422 36,5%. Los factores asociados con la mortalidad a los 42 días fueron la edad, APACHE II, SOFA > 6 y LDH al ingreso > 470 U/L, uso de vasopresores, necesidad de técnicas de reemplazo de la función renal, porcentaje de linfocitos a las 72 horas del ingreso en UCI < 6,5%, y trombocitopenia, mientras que el uso de lopinavir/ritonavir fue identificado como un factor protector. Conclusiones: La edad, gravedad y fracaso orgánico junto con la necesidad de terapias de soporte fueron identificadas como factores predictores de mortalidad a las seis semanas. La administración de corticoesteroides a dosis altas no mostró beneficios en la mortalidad, al igual que el tratamiento con tocilizumab, lopinavir/ritonavir se identificaron como un factor protector (AU)

Early postoperative mortality in liver transplant recipients involving indications other than hepatocellular carcinoma. A retrospective cohort study / Mortalidad postoperatoria precoz en los receptores de trasplante hepático por indicaciones distintas al carcinoma hepatocelular (non-HCC). Estudio retrospectivo de cohortes

Aims: To analyze the perioperative differences in a consecutive cohort of liver transplant recipients (LTRs) classified according to the indication of transplantation, and assess their impact upon early mortality 90 days after transplantation. Design: A retrospective cohort study was carried out.ScopeA single university hospital. Patients: A total of 892 consecutive adult LTRs were included from January 1995 to December 2017. Recipients with acute liver failure, retransplantation or with grafts from non-brain death donors were excluded. Two cohorts were analyzed according to transplant indication: hepatocellular carcinoma (HCC-LTR) versus non-carcinoma (non-HCC-LTR). Main variables of interest: Recipient early mortality was the primary endpoint. The pretransplant recipient and donor characteristics, surgical time data and postoperative complications were analyzed as independent predictors. ResultsThe crude early postoperative mortality rate related to transplant indication was 13.3% in non-HCC-LTR and 6.6% in HCC-LTR (non-adjusted HR=2.12, 95%CI=1.25–3.60; p=0.005). Comparison of the perioperative features between the cohorts revealed multiple differences. Multivariate analysis showed postoperative shock (HR=2.02, 95%CI=1.26–3.24; p=0.003), early graft vascular complications (HR=4.01, 95%CI=2.45–6.56; p<0.001) and multiorgan dysfunction syndrome (HR=18.09, 95%CI=10.70–30.58; p<0.001) to be independent predictors of mortality. There were no differences in early mortality related to transplant indication (adjusted HR=1.60, 95%CI=0.93–2.76; p=0.086). Conclusions: The crude early postoperative mortality rate in non-HCC-LTR was higher than in HCC-LTR, due to a greater incidence of postoperative complications with an impact upon mortality (shock at admission to intensive care and the development of multiorgan dysfunction syndrome). (AU)

Objetivos: Analizar las diferencias perioperatorias de una cohorte de trasplantados hepáticos (LTR) clasificados por la indicación de trasplante, y evaluar su impacto sobre la mortalidad precoz (90 días postrasplante). Diseño: Estudio de cohorte retrospectivo. Ámbito: Institución universitaria. Pacientes: Desde 1995 hasta 2017 fueron incluidos 892 LTR. Se excluyeron los receptores con fallo hepático agudo, retrasplante o de donantes sin muerte cerebral. Se analizaron 2 cohortes según el motivo del trasplante: carcinoma hepatocelular (HCC-LTR) vs. causas diferente al carcinoma (non-HCC-LTR).Principales variables de interés: La variable principal fue la mortalidad precoz. Las características pretrasplante de receptores, donantes, tiempo quirúrgico y complicaciones postoperatorias se estudiaron como predictores independientes. Resultados: La mortalidad postoperatoria temprana bruta relacionada con la indicación de trasplante fue del 13,3% en non-HCC-LTR y del 6,6% en HCC-LTR (HR no ajustada: 2,12; IC 95%: 1,25-3,60; p=0,005). La comparación de características perioperatorias entre las cohortes mostró múltiples diferencias. El shock postoperatorio (HR: 2,02; IC 95%: 1,26-3,24), complicaciones vasculares tempranas del injerto (HR: 4,01; IC 95%: 2,45-6,56) y síndrome de disfunción multiorgánica (HR: 18,09; IC 95%: 10,70-30,58) fueron predictores independientes de mortalidad. La indicación de trasplante no mostró significación en el análisis multivariante (HR ajustada: 1,60; IC 95%: 0,93-2,76; p=0,086). Conclusiones: La mortalidad postoperatoria temprana bruta en non-HCC-LTR fue mayor que en HCC-LTR debido a la mayor incidencia de complicaciones postoperatorias con impacto en la mortalidad (shock al ingreso en la UCI y aparición del síndrome de disfunción multiorgánica). (AU)

Early postoperative mortality in liver transplant recipients involving indications other than hepatocellular carcinoma. A retrospective cohort study.

AIMS: To analyze the perioperative differences in a consecutive cohort of liver transplant recipients (LTRs) classified according to the indication of transplantation, and assess their impact upon early mortality 90 days after transplantation. DESIGN: A retrospective cohort study was carried out. SCOPE: A single university hospital. PATIENTS: A total of 892 consecutive adult LTRs were included from January 1995 to December 2017. Recipients with acute liver failure, retransplantation or with grafts from non-brain death donors were excluded. Two cohorts were analyzed according to transplant indication: hepatocellular carcinoma (HCC-LTR) versus non-carcinoma (non-HCC-LTR). MAIN VARIABLES OF INTEREST: Recipient early mortality was the primary endpoint. The pretransplant recipient and donor characteristics, surgical time data and postoperative complications were analyzed as independent predictors. RESULTS: The crude early postoperative mortality rate related to transplant indication was 13.3% in non-HCC-LTR and 6.6% in HCC-LTR (non-adjusted HR=2.12, 95%CI=1.25-3.60; p=0.005). Comparison of the perioperative features between the cohorts revealed multiple differences. Multivariate analysis showed postoperative shock (HR=2.02, 95%CI=1.26-3.24; p=0.003), early graft vascular complications (HR=4.01, 95%CI=2.45-6.56; p<0.001) and multiorgan dysfunction syndrome (HR=18.09, 95%CI=10.70-30.58; p<0.001) to be independent predictors of mortality. There were no differences in early mortality related to transplant indication (adjusted HR=1.60, 95%CI=0.93-2.76; p=0.086). CONCLUSIONS: The crude early postoperative mortality rate in non-HCC-LTR was higher than in HCC-LTR, due to a greater incidence of postoperative complications with an impact upon mortality (shock at admission to intensive care and the development of multiorgan dysfunction syndrome).

Predictive factors of six-week mortality in critically ill patients with SARS-CoV-2: A multicenter prospective study.

OBJECTIVE: The objective of the study is to identify the risk factors associated with mortality at six weeks, especially by analyzing the role of antivirals and munomodulators. DESIGN: Prospective descriptive multicenter cohort study. SETTING: 26 Intensive care units (ICU) from Andalusian region in Spain. PATIENTS OR PARTICIPANTS: Consecutive critically ill patients with confirmed SARS-CoV-2 infection were included from March 8 to May 30. INTERVENTIONS: None. VARIABLES: Variables analyzed were demographic, severity scores and clinical condition. Support therapy, drug and mortality were analyzed. An univariate followed by multivariate Cox regression with propensity score analysis was applied. RESULTS: 495 patients were enrolled, but 73 of them were excluded for incomplete data. Thus, 422 patients were included in the final analysis. Median age was 63 years and 305 (72.3%) were men. ICU mortality: 144/422 34%; 14 days mortality: 81/422 (19.2%); 28 days mortality: 121/422 (28.7%); 6-week mortality 152/422 36.5%. By multivariable Cox proportional analysis, factors independently associated with 42-day mortality were age, APACHE II score, SOFA score at ICU admission >6, Lactate dehydrogenase at ICU admission >470U/L, Use of vasopressors, extrarenal depuration, %lymphocytes 72h post-ICU admission <6.5%, and thrombocytopenia whereas the use of lopinavir/ritonavir was a protective factor. CONCLUSION: Age, APACHE II, SOFA>value of 6 points, along with vasopressor requirements or renal replacement therapy have been identified as predictor factors of mortality at six weeks. Administration of corticosteroids showed no benefits in mortality, as did treatment with tocilizumab. Lopinavir/ritonavir administration is identified as a protective factor.

Adherencia al uso de audífonos en adultos mayores con hipoacusia: Un ensayo clínico aleatorizado para evaluar un programa de rehabilitación auditiva

Resumen Introducción: La presbiacusia es una condición muy prevalente. Habitualmente se implementan audífonos como tratamiento, pero un problema es la baja adherencia exhibida que puede rondar un 50%. Objetivo: Evaluar si el programa de rehabilitación auditiva Active Communication Education (ACE) mejora la adherencia al uso del audífono. Material y Método: Se realizó un ensayo clínico aleatorizado controlado para evaluar la efectividad del programa ACE sumado a un refuerzo teleeducativo para mejorar la adherencia al uso del audífono. El proyecto fue aprobado por comité de ética y cada participante firmó consentimiento informado. La adherencia se evaluó por medio de la escala CIRUA y Dr. Yueh. Cada participante fue seguido en su domicilio en controles cada 3 meses hasta 1 año posterior a la intervención por encuestadores entrenados. Resultados: Se incluyeron 202 participantes, 101 en cada rama. La mediana de edad fue de 78 años y el 59,9% de la muestra fue de sexo femenino. El PTP promedio óseo fue de 48,59 dB y el aéreo fue de 55 dB. El grupo control tuvo adherencia de 65,91% y 62,30%. El grupo intervencional tuvo una adherencia de 78,41% y 72,28%. Hubo diferencias significativas en el porcentaje de adherencia entre grupo control y experimental según CIRUA (p = 0,027) y Yueh (p = 0,011). Conclusión: El programa de rehabilitación auditiva ACE es eficaz para mejorar la adherencia al uso del audífono en pacientes adultos mayores con hipoacusia. Este estudio representa uno de los mayores esfuerzos publicados para evaluar la efectividad de los programas de rehabilitación auditiva en adultos mayores con hipoacusia.

Abstract Introduction: Hearing loss associated with older adults is a very prevalent condition. Hearing aids are usually implemented as treatment, but there is low adherence exhibited, which can be around 50%. Aim: To assess whether the Active Communication Education (ACE) hearing rehabilitation program improves adherence to hearing aid use. Material and Method: A randomized controlled clinical trial was carried out to evaluate the effectiveness of the ACE program added to a tele-educational reinforcement to improve adherence to hearing aid use. The project was approved by the ethics committee of the institution and each participant signed an informed consent. Adherence was evaluated using the CIRUA scale and Dr. Yueh scale. Each participant was followed at home in controls every 3 months up to 1 year after the intervention by trained interviewers. Results: 202 participants were included, 101 in each branch. The median age was 78 years and 59.9% of the sample was female. The average bone PTA was 48.59 dB and air PTA was 55 dB. Adherence in the control group was 65.91% and 62.30%. In the interventional group, adherence was 78.41% and 72.28%. There were significant differences in the percentage of adherence between the control and experimental groups according to CIRUA (p = 0.027) and Yueh (p = 0.011). Conclusion: The ACE auditory rehabilitation program improves adherence to hearing aid use in older adults with hearing loss. This study represents one of the largest published efforts to evaluate the effectiveness of auditory rehabilitation programs in older adults with hearing loss.

Adherencia al uso de audífonos en adultos mayores chilenos con hipoacusia

Resumen Introducción: Se estima que hasta un 30% de la población mayor de 65 años presenta hipoacusia. Una intervención validada para la hipoacusia en adultos mayores es el uso de audífonos, pero el problema es que hasta un 50% de los adultos mayores no los utiliza. Objetivo: Estimar la adherencia al uso de audífonos en adultos mayores beneficiarios del programa GES de "Hipoacusia bilateral en mayores de 65 años que requieran audífonos" en un hospital en Santiago, Chile. Material y Método: Se utilizó la rama control de un ensayo clínico aleatorizado para estimar la adherencia al uso de audífono con cuestionarios validados y estructurados, por encuestadores entrenados que acudieron a los tres, seis, nueve y doce meses desde la intervención al domicilio de los beneficiarios del programa. Resultados: Se incluyeron 101 adultos mayores. El promedio de edad fue 76,3 años. Al analizar la adherencia considerando un criterio de uso del audífono mayor a 8 h al día, cada día, durante las últimas dos semanas, la adherencia a 3 meses fue un 56,8%, a 6 meses un 62,6%, a 9 meses un 63,2% y a 12 meses un 54,5%. Al analizar considerando uso entre 4-8 h/diarias, la adherencia del período fue entre 73,8% y 87,3%. Según el cuestionario del Dr. Yueh, la adherencia a 3 meses fue un 64,7%, a 6 meses un 63,9%, a 9 meses un 73,7% y a 12 meses un 67,8%. Conclusión: Los resultados del presente análisis muestran una excelente adherencia al uso del audífono en Chile, lo que representa una cifra positiva respecto a la efectividad de la política pública.

Abstract Introduction: It is estimated that up to 30% of the population over 65 years of age present hearing loss. A validated intervention for hearing loss in older adults is the use of hearing aids, but the problem is that up to 50% of older adults do not use them. Aim: To estimate the hearing aid adherence in elderly population with hearing loss who are beneficiaries of the GES program "Bilateral hearing loss in people over 65 who require hearing aids" in a hospital in Santiago, Chile. Material and Method: The control arm of a randomized clinical trial was used to estimate adherence to hearing aid with validated and structured questionnaires, by trained interviewers who visited the beneficiaries of the program at three, six, nine and twelve months posterior to the intervention. Results: 101 older adults were included. The average age was 76.3 years. When analyzing adherence as "use for more than 8 hours a day during the last two weeks", adherence at 3 months was 56.8%, at 6 months 62.6%, at 9 months 63.2%, and at 12 months 54.5%. When analyzing considering use between 4-8 h/day, the adherence during the follow-up was between 73.8% and 87.3%. According to Dr. Yueh's questionnaire, adherence at 3 months was 64.7%, at 6 months 63.9%, at 9 months 73.7%, and at 12 months 67.8%. Conclusion: The results of the present analysis show an excellent adherence to hearing aids in a group of Chilean population, which represents a positive outcome regarding the effectiveness of this particular public policy.

Comité quirúrgico para la hidradenitis supurativa: nuestra experiencia / Hidradenitis Suppurative: Our Experience with a Surgical Case Management Team

ANTECEDENTES Y OBJETIVOS: La complejidad del tratamiento de la hidradenitis supurativa (HS) hace necesario un abordaje multidisciplinar, y con este fin diseñamos un comité quirúrgico para su abordaje. Este estudio describe las características clínicas de los pacientes evaluados y los resultados de las técnicas quirúrgicas realizadas. MATERIAL Y MÉTODOS: Presentamos un estudio descriptivo transversal que recoge 104 pacientes que fueron evaluados en nuestro comité desde setiembre de 2015 hasta julio de 2018. RESULTADOS: En nuestra serie, el 46% de los pacientes con HS evaluados recibieron tratamiento quirúrgico. La mayoría fueron varones (73%), sin antecedentes familiares de HS (63%), exfumadores o fumadores (76%). El fenotipo clínico predominante fue el tipo III (41%), con presencia de patología grave en la mayor parte de los casos (36% con Hurley II y 46% con Hurley III). Las áreas anatómicas más afectadas fueron las axilas (51,9%) y las ingles (41,3%); mientras que las intervenidas con mayor frecuencia fueron la axilar (38,3%), seguida de la glútea (23,4%). Entre los tratamientos médicos, el más usado fue la combinación de rifampicina con clindamicina. El destechamiento (deroofing) se posicionó como la técnica quirúrgica más empleada entre los pacientes intervenidos (hasta en un 48%). En cuanto al resultado posquirúrgico global: un 63,4% obtuvo un resultado satisfactorio, un 20% recidivó y un 12% presentó dehiscencia de la herida quirúrgica. CONCLUSIONES: Dada nuestra experiencia, recomendamos la instauración de comités multidisciplinares para mejorar la comunicación entre los diferentes especialistas, así como individualizar el tratamiento y mejorar el seguimiento de los pacientes con HS

BACKGROUND AND OBJECTIVES: The complexity of hidradenitis suppurativa (HS) treatment calls for a multidisciplinary approach. We therefore created a multidisciplinary team to manage surgical care. This study aimed to describe the clinical characteristics of the patients we evaluated and the outcomes of the surgical techniques used. MATERIAL AND METHODS: Descriptive cross-sectional study of 104 patients evaluated by our surgical case management team between September 2015 and July 2018. RESULTS: Surgery was used to treat 46% of the patients with HS who were evaluated. Most were men (73%) with no family history of HS (63%) and smokers or former smokers (76%). Gluteal HS comprised the largest phenotype group (41%) and the majority of cases were serious (Hurley stage II, 36%; stage III, 46%). The anatomical regions with the largest number of lesions were the axillae (51.9%) and the groin (41.3%). Surgery was most often performed in the axilla (38.3%), followed by the gluteus (23.4%). The most common drug treatment was a combination of rifampicin and clindamycin, Deroofing was the technique used most often (in 48% of the patients who underwent surgery). Postoperative outcomes were assessed as satisfactory overall in 63.4% of the cases. The HS lesion recurred in 20% and 12% developed wound dehiscence. CONCLUSIONS: Our experience leads us to recommend forming multidisciplinary teams to improve communication between specialists, provide tailored treatment for the patient with HS, and improve follow-up

Hidradenitis Suppurative: Our Experience with a Surgical Case Management Team. / Comité quirúrgico para la hidradenitis supurativa: nuestra experiencia.

BACKGROUND AND OBJECTIVES: The complexity of hidradenitis suppurativa (HS) treatment calls for a multidisciplinary approach. We therefore created a multidisciplinary team to manage surgical care. This study aimed to describe the clinical characteristics of the patients we evaluated and the outcomes of the surgical techniques used. MATERIAL AND METHODS: Descriptive cross-sectional study of 104 patients evaluated by our surgical case management team between September 2015 and July 2018. RESULTS: Surgery was used to treat 46% of the patients with HS who were evaluated. Most were men (73%) with no family history of HS (63%) and smokers or former smokers (76%). Gluteal HS comprised the largest phenotype group (41%) and the majority of cases were serious (Hurley stage II, 36%; stage III, 46%). The anatomical regions with the largest number of lesions were the axillae (51.9%) and the groin (41.3%). Surgery was most often performed in the axilla (38.3%), followed by the gluteus (23.4%). The most common drug treatment was a combination of rifampicin and clindamycin, Deroofing was the technique used most often (in 48% of the patients who underwent surgery). Postoperative outcomes were assessed as satisfactory overall in 63.4% of the cases. The HS lesion recurred in 20% and 12% developed wound dehiscence. CONCLUSIONS: Our experience leads us to recommend forming multidisciplinary teams to improve communication between specialists, provide tailored treatment for the patient with HS, and improve follow-up.

La Revista Española de Medicina Nuclear e Imagen Molecular en 2020 / Revista Española de Medicina Nuclear e Imagen Molecular in 2020

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Effectiveness and safety of perampanel as early add-on treatment in patients with epilepsy and focal seizures in the routine clinical practice: Spain prospective study (PERADON).

OBJECTIVE: Perampanel (PER) has been shown to be effective as an adjunctive therapy for controlling refractory focal-onset seizures (FOS). However, the information as early add-on for the treatment of FOS in the clinical practice is still scarce and must be further assessed. METHODS: An observational prospective study was conducted to evaluate the effectiveness of early add-on PER, assessed as 50% responders (seizure frequency reduced by at least 50% during the last 3 months as compared with baseline) rate at 6 and 12 months, in patients with FOS in the routine clinical practice of Spain. RESULTS: One hundred and thirteen patients (mean age: 40.3 years, 51.3% male) with FOS received PER as early add-on (1st add-on: 37.2% and 2nd: 62.8%) for a mean exposure of 11 months (mean PER dose: 6.3 mg/day at month 12). At 6 months, 50.4% and 20.4% of the patients were responders and seizure-free (respectively) relative to baseline (3 months prior to PER initiation), and at 12 months, 68.1% and 26.5% of the patients were responders and seizure-free (respectively), relative to baseline (3 months prior to PER initiation). The retention rate at 6 and 12 months was 83.2% and 80.5%, respectively. The percentage of seizure-free patients at 12 months was significantly (p = 0.033) higher when PER was added as first vs. second add-on. The number of concomitant antiepileptic drugs (AEDs) was significantly reduced from baseline to 6 and 12 months (p = 0.001). Treatment was simplified in 23.9% of patients at the end of the observation period. Drug-related adverse events (AEs), most mild or moderate, were reported in 30.1% of patients, with irritability (8%) and dizziness (7.1%) as the most frequent ones. CONCLUSIONS: This is the first observational, prospective study to evaluate efficacy and safety of early adjunctive treatment with PER in patients with focal epilepsy at 12 months. Perampanel demonstrated a good efficacy and safety profile when used at a median dose of 6 mg/day, regardless of the combination with other AEDs. Adverse events were mild or moderate, with dizziness being the most frequent one.