Long-term effectiveness and safety of tolvaptan in autosomal dominant polycystic kidney disease.

BACKGROUND AND OBJECTIVES: Evidence on the long-term use of tolvaptan in autosomal dominant polycystic kidney disease (ADPKD) is limited. The aim was to evaluate the tolvaptan effectiveness and safety in real clinical setting. MATERIAL AND METHODS: A single-center observational study (2016-2022) involving ADPKD patients treated with tolvaptan was conducted. Annual change in serum creatinine (sCr) and estimated glomerular filtration rate (eGFR) before and after treatment initiation were evaluated. Change in total kidney volume (TKV), blood pressure (BP) and urinary albuminuria at 12, 24 and 36 months after initiation were also determined. Adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 were analyzed. RESULTS: A total of 22 patients were included. No significant differences pre- vs post tolvaptan treatment in annual rate of change in eGFR (-3.52ml/min/1.73m2 [-4.98%] vs -3.98ml/min/1.73m2 [-8.48%], p=0.121) and sCr (+0.06mg/dL [4.22%] vs +0.15mg/dL [7.77%], p=0.429) were observed. Tolvaptan improved urinary osmolality at 12 (p=0.019) and 24 months (p=0.008), but not at 36 months (p=0.11). There were no changes in TKV, BP control and urinary albuminuria at 12, 24 or 36 months. A worse response was shown in patients with rapid kidney function decline (p=0.042). A 36.4% of the patients developed grade III/IV AEs. A 22.7% discontinued treatment due to unacceptable toxicity. CONCLUSIONS: This study shows a modest benefit of tolvaptan in ADPKD patients, as well as safety concerns.

Efficacy and acceptability of music therapy for post-traumatic stress disorder: a systematic review and meta-analysis of randomized controlled trials.

Background: Music therapy is increasingly examined in randomized controlled trials (RCTs) and shows potential in treating post-traumatic stress disorder (PTSD).Objective: This systematic review and meta-analysis critically evaluates the current clinical evidence supporting the efficacy and acceptability of music therapy for PTSD.Method: RCTs comparing music therapy in addition to care as usual (CAU) versus either CAU alone or CAU combined with standard psychotherapy/pharmacotherapy for PTSD were retrieved from major English - and Chinese-language databases. Standardized mean differences (SMDs) for post-treatment PTSD symptom scores and risk differences (RDs) for retention rates upon treatment completion were calculated to assess the efficacy and acceptability of music therapy, respectively. The Cochrane risk of bias (RoB) tool 2.0 and the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) were used to assess the RoB of included studies and certainty of the evidence, respectively.Results: Nine studies, incorporating 527 PTSD patients, were included, all with high RoB. The post-treatment PTSD symptom scores were significantly lower in the music therapy group than the inactive control group (SMD = -1.64, P < .001), but comparable between the music therapy group and the active control group (SMD = -0.28, P = .330). The retention rates did not differ significantly between the music therapy group and both control groups (RD = 0.03, P = .769; RD = 0.16, P = .829). The GRADE rated certainty level of evidence as low.Conclusions: Although meta-analytic findings suggest that music therapy is effective in reducing post-traumatic symptoms in individuals with PTSD, with its therapeutic effect comparable to that of standard psychotherapy, the low level of certainty limits its generalizability. More methodologically stringent studies are warranted to strengthen the clinical evidence for the efficacy and acceptability of music therapy for PTSD.

This systematic review critically appraised the existing methodologically rigorous evidence for the efficacy and acceptability of music therapy for post-traumatic stress disorder (PTSD).The post-treatment PTSD symptom scores were significantly lower in the music therapy group than the inactive control group and comparable between the music therapy group and the active control group.The post-treatment retention rates did not differ significantly between the music therapy group and both the inactive and active control groups.

Effectiveness and safety of injectable PCSK9 inhibitors in dyslipidaemias’ treatment and cardiovascular disease prevention: An overview of 86 systematic reviews and a network metaanalysis / Eficacia y seguridad de los inyectables inhibidores de la PCSK9 en el tratamiento de dislipidemias y la prevención de enfermedades cardiovasculares: una visión general de 86 revisiones sistemáticas y un metaanálisis en red

Objective Multiple systematic reviews (SR) have been performed on the effects of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i), often providing conflicting findings. This overview and network meta-analysis (NMA) aimed to summarize SR findings on the efficacy and safety of PCSK9i and provide an updated NMA. Materials and methods MEDLINE (Pubmed), Scopus, Cochrane, Epistemonikos and Google Scholar were searched from inception to September 21, 2023 for SRs of randomized controlled trials (RCTs) and from January 1, 2020 to September 21, 2023 for additional RCTs. Double-independent study selection, data extraction and quality assessment were performed. Qualitative analysis was performed for SRs and a frequentist random-effects model NMA was performed for RCTs. Results Totally, 86 SRs and 76 RCTs were included. Alirocumab (77/86 [90%]) and evolocumab (73/86 [85%]) were mostly analyzed. Associations from SRs (35/42 [83%]) and the updated NMA indicated PCSK9i benefit on major adverse cardiovascular events (MACEs). Reductions were also noted for cerebrovascular events (47/66 [71%]), coronary revascularization (29/33 [88%]) and myocardial infarction (41/63 [65%]). Alirocumab was associated with reductions on all-cause mortality (RR=0.82, 95%CI [0.72,0.94]). Data on any CV event reduction were conflicting (7/16 [44%]). Inclisiran appeared effective only on MACEs (RR=0.76, 95%CI [0.61,0.94]). No reductions in heart failure were observed (0/16). No increases were identified between PCSK9i and any (0/35) or serious adverse events (0/52). However, PCSK9i were associated with injection-site reactions (20/28 [71%]). Conclusion PCSK9i appeared to be effective in CV outcomes and their clinical application was generally safe. (AU)

Objetivo Las revisiones sistemáticas (RS) sobre los efectos de los inhibidores de la proproteína convertasa subtilisina/kexina tipo 9 (PCSK9i), presentan resultados contradictorios. Esta revisión general y metaanálisis en red (MER) tiene como objetivo resumir los hallazgos sobre la eficacia y seguridad de los PCSK9i. Materiales y métodos Se realizaron búsquedas en MEDLINE (PubMed), Scopus, Cochrane, Epistemonikos y Google Scholar desde sus inicios hasta el 21 de septiembre de 2023 para las RS de ensayos controlados aleatorios (ECA) y desde el 1 de enero de 2020 hasta 21 de septiembre de 2023 para los ECA adicionales. La selección de estudios, extracción de datos y evaluación de calidad se llevaron a cabo de manera doble e independiente. Se realizó un análisis cualitativo de las SR y un modelo de efectos aleatorios frecuentistas MER para los ECA. Resultados En total, se incluyeron 86 SR y 76 RCT. Alirocumab (77/86 [90%]) y evolocumab (73/86 [85%]) fueron los más analizados. Se reconocieron beneficios de los PCSK9i en eventos cardiovasculares adversos mayores (ECVAM), reducción de eventos cerebrovasculares (47/66 [71%]), revascularización coronaria (29/33 [88%]) e infartos de miocardio (41/63 [65%]). Alirocumab redujo la mortalidad por todas las causas (RR: 0,82; IC del 95%: 0,72-0,94). Los resultados sobre la reducción de cualquier evento cardiovascular (CV) fueron contradictorios (7/16 [44%]). Inclisiran pareció ser efectivo solo en la reducción de ECVAM (RR: 0,76; IC del 95%: 0,61-0,94). No se observaron reducciones en insuficiencia cardíaca (0/16) o relación con eventos adversos serios (0/52). Sin embargo, se asociaron con reacciones en el lugar de la inyección (20/28 [71%]). (AU)

The Moderating Role of Perceived Efficacy of COVID-19 Prevention Measures on the Relation Between Perceived Risk and Perceived Mental Health / El rol moderador de la eficacia percibida de las medidas de prevención frente al COVID-19 en la relación entre la percepción de riesgo y la salud mental percibida

La pandemia del COVID-19 ha llevado a los países a adoptar severas y prolongadas medidas que —junto con el alto número de contagios y muertes y la continua información negativa— ha afectado la salud mental de las personas. Este estudio analiza el impacto de la crisis sanitaria del COVID-19 en España explorando el rol moderador de la eficacia percibida de las medidas de contención en la relación que establece la percepción del riesgo del COVID-19 con el estrés y la depresión. Un total de 478 adultos residentes en España (un 66.9% mujeres; Medad = 36.30, DT = 15.32) completaron un cuestionario con escalas concebidas para medir el riesgo percibido del COVID-19, la eficacia percibida de las medidas de protección, el estrés y la depresión entre el 16 de mayo y el 6 de junio de 2021. Los resultados confirmaron el rol moderador de la eficacia percibida, la cual actuó como un factor protector del estrés y la depresión al disminuir el impacto negativo que la percepción de riesgo del COVID-19 tiene en ambas variables relacionadas con el distrés mental. La percepción que tienen los individuos sobre la efectividad de las medidas de protección parece ser un factor protector relevante en relación con la salud mental durante una pandemia. Se subraya la relevancia de intervenciones psicológicas y de políticas gubernamentales que mejoren la comunicación positiva del riesgo y la información adecuada sobre la eficacia de las medidas de protección.(AU)

The pandemic situation caused by COVID-19 led countries to adopt harsh and prolonged (over time) measures that—along with the high number of infections and deaths and continuous negative information—have affected the mental health of individuals. In this study, the impact on mental health of the COVID-19 health crisis in Spain was explored through the perceived efficacy of pandemic containment measures as a moderator of the relationship that COVID-19 perceived risk establishes with stress and depression. A questionnaire composed of scales conceived to measure COVID-19 perceived risk, perceived efficacy of COVID-19 prevention measures, stress, and depression was completed by 478 adults living in Spain (66.9% females, Mage= 36.30, SD= 15.32) between May 16, 2021, and June 6, 2021. The results confirmed the moderating role of per-ceived efficacy. Perceived efficacy acted as a protective factor for stress and depression by decreasing the negative impact that perceived risk had on both variables related to mentaldistress. Also, the perception that par-ticipants had about the effectiveness of prevention measures appeared to be a relevant protective factor regarding mental health during the pandem-ic. This study highlights the relevance of psychological interventions and government policies that improve positive risk communication and pro-vide adequate information regarding the effectiveness of health-prevention measures.(AU)

52-WEEK MID-TERM EFFICACY OF TILDRAKIZUMAB IN MODERATE-TO-SEVERE PSORIASIS: A REAL-LIFE MULTICENTER EXPERIENCE.

Tildrakizumab is an IL-23-inhibitor that has been approved to treat plaque psoriasis. However, few reports have become available on its efficacy profile in the real-world. Our objective was to study the mid-term efficacy of tildrakizumab in patients with moderate-to-severe psoriasis in the Spanish routine clinical practice setting. This was a retrospective multicenter study that included a total of 91 psoriatic patients on tildrakizumab. The mean Psoriasis Area and Severity Index (PASI) was 9.09 (SD, 5.30). The overall tildrakizumab survival rate was 93.47% for a mean treatment exposure of 30.18 weeks (SD, 16,57). No drug discontinuation was associated with drug tolerability, or adverse reactions. Absolute PASI ≤ 3 was reached by 91.3% and 96.5% of the patients on weeks 28 and 52, respectively. Response was not impacted by weight, age (> 65), metabolic syndrome, presence of arthritis, or previous number of biological therapies used. Based on our own experience tildrakizumab is an effective strategy to treat plaque psoriasis and difficult-to-treat-areas.

Eficacia y seguridad de la vacunación antigripal pediátrica: una revisión sistemática / Efficacy and safety of pediatric flu vaccination: a systematic review

Introducción. Los a corren un mayor riesgo de infección por influenza en comparación con la población general. La Organización Mundial la Salud y las recomendaciones del Comité Asesor de Vacunas de la Asociación Española de Pediatría contemplan la vacunación anual como la forma más eficaz de prevenir la enfermedad. Por lo tanto, el propósito de esta revisión fue actualizar la información sobre eficacia y seguridad en la vacuna antigripal en niños y adolescentes. Material y métodos. Una búsqueda en cuatro bases de datos electrónicas (Scopus, Cumulative Index to Nursing and Allied Health Literature, MedLine / PubMed, Google Scholar y Cochrane), así como una búsqueda manual para identificar investigaciones originales publicadas entre 2012 y 2022. Se adoptaron las directrices de análisis (PRISMAcR) como elemento de informe preferido para revisiones sistemáticas. Resultados. Se incluyeron siete artículos de investigación originales donde se identificaron dos temas de la vacunación antigripal en niños/adolescentes sanos y con patologías. La eficacia (entre un 30% y un 80% aproximadamente) varió en función de la vacuna utilizada y los subtipos circulantes. La mayoría de las reacciones adversas fueron de intensidad leve y el evento adverso local más común informado fue dolor en el sitio de la inyección. Conclusiones. Destacamos positivamente la seguridad de la vacunación antigripal pediátrica en los estudios analizados, por el contrario, con respecto a la eficacia de la vacunación antigripal, observamos una amplia variabilidad de resultados. Existe una clara necesidad de seguir realizando estudios de eficacia y seguridad en el niño. (AU)

Introduction. Children are at a higher risk of influenza infection compared to the general population. The World Organization Health and recommendations of the Vaccine Advisory Committee of the Spanish Association of Pediatrics contemplate annual vaccination as the most effective way to prevent the disease. Therefore, the purpose of this review was to update information on efficacy and safety in the anti -shed vaccine in children and adolescents. Material and methods. A search in four electronic databases (Scopus, Cumulative Index to Nursing and Allied Health Literature, Medline / Pubmed, Google Scholar and Cochrane), as well as a manual search to identify original research published between 2012 and 2022. The guidelines of ANALYSIS (PRISMACR) as a preferred report element for systematic reviews. Results. Seven original research articles were included where two issues of antigripal vaccination were identified in healthy children/adolescents and with pathologies. The efficacy (between approximately 30% and 80%) varied depending on the vaccine used and circulating subtypes. Most adverse reactions were mild intensity, and the most common local adverse event was pain in the injection site. Conclusions. We positively highlight the safety of pediatric flu vaccination in analyzed studies, on the contrary, with respect to the efficacy of flu vaccination, we observe a wide variability of results. There is a clear need to continue conducting efficacy and safety studies in the child. (AU)

Estudio piloto sobre la eficacia de un tratamiento transdiagnóstico para trastornos emocionales en Atención Primaria / A Pilot Study of the Effectiveness of a Transdiagnostic Treatment for Emotional Disorders in Primary Care

Este estudio tuvo como objetivo evaluar y determinar la eficacia de un tratamiento transdiagnóstico breve en formato grupal para personas con trastornos emocionales leves y moderados y establecer correlaciones entre los cambios tras el tratamiento en las diferentes variables. Para ello, se usó un diseño experimental de grupo único (n=11) con medidas pre-post. Los participantes fueron evaluados antes y después de la intervención con las siguientes medidas: PHQ-15, PHQ-9, GAD-7, PSQW-A, RRS-B y CERQ-18. Se encontró que la terapia transdiagnóstica breve fue efectiva para reducir los síntomas depresivos (p =.005), síntomas ansiosos (p =.011) y preocupación (p = .020) con tamaños del efecto alto. Además, se encontraron correlaciones significativas positivas entre los cambios de las variables de síntomas depresivos y preocupación y entre los cambios en síntomas ansiosos y rumiación. Se concluyó que los tratamientos transdiagnóticos breves pueden ser una opción a tener en cuenta para los pacientes con trastornos emocionales leves y moderados en atención primaria debido a su eficacia en algunos síntomas y sus características. (AU)

This study aimed to evaluate and determine the efficacy of a brief transdiagnostic treatment in group format for people with mild and moderate emotional disorders, and to establish correlations between the changes after treatment in the different variables. We use a single experimental group (n=11) design with pre-post measures. Participants were assessed pre- and post-intervention with the following measures: PHQ-15, PHQ-9, GAD-7, PSQW-A, RRS-B, and CERQ-18. Brief transdiagnostic therapy was found to be effective in reducing depressive symptoms (p =.005), anxious symptoms (p=.011), and worry (p=.020) with high/moderate effect sizes. In addition, significant positive correlations were found between changes in depressive symptoms and worry variables, and between changes in anxious symptoms and rumination. In conclusion, brief transdiagnostic treatments can be a treatment to consider for patients with mild and moderate emotional disorders in primary care due to their efficacy in some symptoms and their characteristics. (AU)

Motivational orientation and intention to be physically active in physical education students: The role of motor self-efficacy / Orientação motivacional e intenção de ser fisicamente ativo em estudantes de educação física: O papel da auto-eficácia motora / Orientación motivacional e intención de ser físicamente activo en estudiantes de educación física: El papel de la autoeficacia motriz

La motivación orientada a la tarea se vincula con la tendencia de los estudiantes de Educación Física a asociarse con una mayor probabilidad de ser físicamente activos en el futuro y fuera de las clases de Educación Física, mientras que la motivación orientada al ego estaría vinculada a una menor probabilidad de desarrollar estilos de vida activos. Además, la literatura existente ha mostrado que la percepción de autoeficacia también sería una variable que determina la intención de ser activo. Así, el objetivo de esta investigación fue analizar las relaciones entre la orientación motivacional y la intención de ser activo, analizando el papel de la autoeficacia motriz en estas relaciones. Para ello, se desarrolló un modelo de ecuaciones estructurales en el que se evaluaron los efectos directos e indirectos entre las variables. Participaron en esta investigación 478 adolescentes con edades comprendidas entre los 13 y los 18 años (M=14.57; DT=1.15). Para la recogida de información se utilizaron elCuestionario Orientación al Ego y a la Tarea en el Deporte (TEOSQ), la Escala de Autoeficacia Motriz (MSES) y la Escala de Intención de Ser Físicamente Activo (MIFA). Los datos mostraron una relación positiva y directa entre la orientación a la tarea con la autoeficacia motriz y la intención de ser activo. Asimismo, los datos mostraron una relación positiva y directa entre la orientaciónal ego con la autoeficacia motora, pero no con la intención de ser activo. Asimismo, se observaron efectos indirectos y positivos entre la orientación a la tarea y al ego con la intención de ser activo. Por lo tanto, los resultados de este estudio muestran que podría ser necesario tener en cuenta la autoeficacia para comprender mejor las relaciones entre las orientaciones motivacionales y la intención de ser activo.(AU)

Task-oriented is linked to the tendency of Physical Education students to be associated with a higher likelihoodof being physically active in the future and outside of Physical Education classes, while ego-oriented motivation is linked to a lower likelihood of developing active lifestyles. However, existing literature has shown that self-efficacy perception is also a variable that determines the intention to be active. Thus, this research aimed to analyze the relationships between motivational orientationand the intention to be active, examining the role of motor self-efficacy in these relationships. To this end, astructural equation model was developed in which direct and indirect effects between the variables were evaluated. A total of 478 adolescents aged between 13 and 18 years old (M=14.57; SD=1.15) participated in this research. The Task and Ego Orientation in Sport Questionnaire (TEOSQ), the Motor Self-Efficacy Scale (MSES), and the Intention of Being Physically Active Scale (MIFA) were used to collect information. The data showed a positive and direct relationship between task orientation with motor self-efficacy and intention to be active. Likewise, the data showed a positive and direct relationship between ego orientation and motor self-efficacy, but not to be active. Additionally, indirect and positive effects were observed between task and ego orientation to be active. Therefore, the results of this study suggest that it might be necessary to consider self-efficacy to better understand the relationships between motivational orientations and intention to be active.(AU)

A orientação para a tarefa está ligada à tendência dos estudantes de Educação Física para serem fisicamente activos no futuro bem como fora das aulas de Educação Física. Por outro lado, a orientação para o ego está mais relacionada com uma menor probabilidade de desenvolverem estilos de vida activos. No entanto, a literatura existente tem demonstrado que a perceção de auto-eficácia seria também uma variável que determina a intenção de ser ativo. Assim, o objetivodo presente estudo foi analisar as relações entre a orientação motivacional e a intenção de ser ativo, analisando o papel da auto-eficácia motora nestas relações. Para isso, foi desenvolvido um modelo de equações estruturais no qual foram avaliados os efeitos diretos e indiretos. Participaram nesta investigação 478 adolescentes com idades compreendidas entre os 13 e os 18 anos (M=14,57; DP=1,15). Para a recolha de informação foram utilizados o Task and Ego Orientation in Sport Questionnaire (TEOSQ), aMotor Self-Efficacy Scale (MSES) e a Intention ofBeing Physically Active Scale (MIFA). Os dados revelaram uma relação positiva e direta entre a orientação para a tarefa, a auto-eficácia motora e a intenção de ser ativo. Além disso, os dados revelaram uma relação positiva e direta entre a orientação para o ego e a auto-eficácia motora, mas não com a intenção de ser ativo. Da mesma forma, foram observados efeitos indirectos positivos entre a orientação para a tarefa e a orientação para o ego com a intenção de ser ativo. Portanto, os resultados deste estudo sugerem que pode ser necessário considerar a autoeficácia para entender as relações entre as orientações motivacionais e a intenção de ser ativo.(AU)

Consensus statement of the Spanish Society of Neurology on the treatment of multiple sclerosis and holistic patient management in 2023.

The last consensus statement of the Spanish Society of Neurology's Demyelinating Diseases Study Group on the treatment of multiple sclerosis (MS) was issued in 2016. Although many of the positions taken remain valid, there have been significant changes in the management and treatment of MS, both due to the approval of new drugs with different action mechanisms and due to the evolution of previously fixed concepts. This has enabled new approaches to specific situations such as pregnancy and vaccination, and the inclusion of new variables in clinical decision-making, such as the early use of high-efficacy disease-modifying therapies (DMT), consideration of the patient's perspective, and the use of such novel technologies as remote monitoring. In the light of these changes, this updated consensus statement, developed according to the Delphi method, seeks to reflect the new paradigm in the management of patients with MS, based on the available scientific evidence and the clinical expertise of the participants. The most significant recommendations are that immunomodulatory DMT be started in patients with radiologically isolated syndrome with persistent radiological activity, that patient perspectives be considered, and that the term "lines of therapy" no longer be used in the classification of DMTs (> 90% consensus). Following diagnosis of MS, the first DMT should be selected according to the presence/absence of factors of poor prognosis (whether epidemiological, clinical, radiological, or biomarkers) for the occurrence of new relapses or progression of disability; high-efficacy DMTs may be considered from disease onset.

Estudio piloto sobre la eficacia de un tratamiento transdiagnóstico para trastornos emocionales en Atención Primaria / A Pilot Study of the Effectiveness of a Transdiagnostic Treatment for Emotional Disorders in Primary Care

Este estudio tuvo como objetivo evaluar y determinar la eficacia de un tratamiento transdiagnóstico breve en formato grupal para personas con trastornos emocionales leves y moderados y establecer correlaciones entre los cambios tras el tratamiento en las diferentes variables. Para ello, se usó un diseño experimental de grupo único (n=11) con medidas pre-post. Los participantes fueron evaluados antes y después de la intervención con las siguientes medidas: PHQ-15, PHQ-9, GAD-7, PSQW-A, RRS-B y CERQ-18. Se encontró que la terapia transdiagnóstica breve fue efectiva para reducir los síntomas depresivos (p =.005), síntomas ansiosos (p =.011) y preocupación (p = .020) con tamaños del efecto alto. Además, se encontraron correlaciones significativas positivas entre los cambios de las variables de síntomas depresivos y preocupación y entre los cambios en síntomas ansiosos y rumiación. Se concluyó que los tratamientos transdiagnóticos breves pueden ser una opción a tener en cuenta para los pacientes con trastornos emocionales leves y moderados en atención primaria debido a su eficacia en algunos síntomas y sus características. (AU)

This study aimed to evaluate and determine the efficacy of a brief transdiagnostic treatment in group format for people with mild and moderate emotional disorders, and to establish correlations between the changes after treatment in the different variables. We use a single experimental group (n=11) design with pre-post measures. Participants were assessed pre- and post-intervention with the following measures: PHQ-15, PHQ-9, GAD-7, PSQW-A, RRS-B, and CERQ-18. Brief transdiagnostic therapy was found to be effective in reducing depressive symptoms (p =.005), anxious symptoms (p=.011), and worry (p=.020) with high/moderate effect sizes. In addition, significant positive correlations were found between changes in depressive symptoms and worry variables, and between changes in anxious symptoms and rumination. In conclusion, brief transdiagnostic treatments can be a treatment to consider for patients with mild and moderate emotional disorders in primary care due to their efficacy in some symptoms and their characteristics. (AU)

Actualización en prevención de VRS: Nirsevimab vs vacunación en embarazadas (RSVpreF) / Update on RSV prevention: Nirsevimab vs vaccination in pregnant women (RSVpreF)

El anticuerpo monoclonal Nirsevimab fue el primero que se implantó para la prevención de infección por virus respiratorio sincitial (VRS) de todos los lactantes en sus primeros meses de vida. Recientemente se ha aprobado el uso de una vacuna en la embarazada (RSVpreF) con distinta forma de inmunización pero el mismo objetivo en el lactante. De este modo, surge la necesidad de valorar una nueva estrategia de inmunización. Desarrollo. Nirsevimab demostró en ensayos clínicos buenos datos de eficacia clínica y de seguridad. Tras su inclusión en la temporada epidémica 2023-2024, la cobertura en España ha sido muy alta y los resultados preliminares parecen mantener la tendencia de los ensayos. Queda pendiente una valoración adecuada de su eficiencia. RSVpreF tiene resultados similares pero, de momento, solo en ensayos y, aunque podría tener alguna ventaja inmunológica, se desconoce si se traduciría en eficacia real. Aún así, esta nueva vacuna respaldada por organismos sanitarios y científicos sería una alternativa segura y eficaz. Por otro lado, incluso con la implementación en el calendario vacunal de RSVpreF, Nirsevimab va a continuar siendo clave en la protección de ciertos lactantes. Conclusión. La aprobación de la vacuna en la embarazada RSVpreF añade una segunda herramienta inmunológica frente a la infección por VRS en lactantes. RSVpreF y Nirsevimab pueden desarrollar un papel complementario en la prevención de estas infecciones.(AU)

Introduction: Nirsevimab was the first monoclonal antibody to be implemented in order to prevent respiratory syncytial virus (RSV) infection in all infants in their first months of life. The use of a vaccine in pregnant women (RSVpreF) using a different way of immunization but still sharing the same objective in infants has recently been approved. Thus, there is a necessity to evaluate a new immunization strategy. Development. Nirsevimab showed good clinical efficacy and safety data in medical trials. After its inclusion in the 2023-2024 epidemic season, coverage in Spain has been very high and preliminary results seem to maintain the trend shown in the trials. An adequate assessment of its efficiency is still pending. RSVpreF has similar results but, for now, only in trials and although it could have some immunological advantages, it is unknown if it would result in actual efficacy. Even so, this new vaccine, supported by health and scientific organizations, would provide a safe and effective alternative. Nonetheless, even with the implementation in the RSVpreF vaccine schedule, Nirsevimab will continue to be a key factor in the protection of certain infants. Conclusion. The approval of the RSVpreF vaccine in pregnant women adds a second immunological tool against RSV infections in infants. RSVpreF and Nirsevimab may play a complementary role in the prevention of these infections.(AU)

Positioning of Tezepelumab in Severe Asthma / Posicionamento do Tezepelumabe na Asma Grave

Asthma is one of the most common chronic diseases and is estimated to be severe in 3%-10% of affected patients. There is a need for additional biologic treatments that are highly efficacious across the spectrum of severe uncontrolled asthma. Currently available drugs inhibit 1 or 2 specific cytokines or IgE antibodies and thus only partially suppress the complex type 2 (T2) inflammatory cascade. Biologics targeting more upstream molecules in the pathophysiological pathway of asthma could treat asthma more effectively. Tezepelumab is a human monoclonal immunoglobulin G2λ antibody that targets the cytokine thymic stromal lymphopoietin (TSLP). It is the first marketed biologic against an epithelial cell–derived cytokine, preventing binding of TSLP to its receptor and reducing the immune stimuli that TSLP can trigger in different asthma endotypes. Tezepelumab reduces downstream biomarkers of inflammation, such as blood and airway eosinophils, FeNO, IgE, IL-5, and IL-13. Tezepelumab provides a clinical benefit in severe asthma, reducing the annualized asthma exacerbation rate in patients with either high or low levels of biomarkers of T2 inflammation, although the effect is greater among those with high levels. The drug has been shown to improve asthma control, quality of life, and lung function and reduce airway hyperresponsiveness. Therefore, tezepelumab can be used across the spectrum of patients with severe uncontrolled asthma, especially in T2-high patients. This review includes a positioning statement by the authors, all of whom are members of the SEAIC Asthma Committee (AU)

A asma é uma das doenças crônicas mais comuns e estima-se que seja grave em 3% a 10% dos pacientes afetados. Há necessidade de tratamentos biológicos adicionais que sejam altamente eficazes em todo o espectro da asma grave não controlada. Os medicamentos atualmente disponíveis inibem 1 ou 2 citocinas específicas ou anticorpos IgE e, portanto, suprimem apenas parcialmente a cascata inflamatória complexa tipo 2 (T2). Os produtos biológicos que visam moléculas mais a montante na via fisiopatológica da asma poderiam tratar a asma de forma mais eficaz. Tezepelumab é um anticorpo monoclonal humano imunoglobulina G2λ que tem como alvo a citocina linfopoietina estromal tímica (TSLP). É o primeiro produto biológico comercializado contra uma citocina derivada de células epiteliais, impedindo a ligação da TSLP ao seu receptor e reduzindo os estímulos imunológicos que a TSLP pode desencadear em diferentes endótipos de asma. Tezepelumabe reduz biomarcadores de inflamação a jusante, como eosinófilos no sangue e nas vias aéreas, FeNO, IgE, IL-5 e IL-13. O tezepelumab proporciona um benefício clínico na asma grave, reduzindo a taxa anualizada de exacerbação da asma em pacientes com níveis elevados ou baixos de biomarcadores de inflamação T2, embora o efeito seja maior entre aqueles com níveis elevados. Foi demonstrado que o medicamento melhora o controle da asma, a qualidade de vida e a função pulmonar e reduz a hiperresponsividade das vias aéreas. Portanto, o tezepelumabe pode ser usado em todo o espectro de pacientes com asma grave não controlada, especialmente em pacientes com T2 elevado. Esta revisão inclui uma declaração de posicionamento dos autores, todos membros do Comitê de Asma da SEAIC (AU)

Vaccine effectiveness in preventing deaths in people with severe acute respiratory syndrome due to COVID-19 in Blumenau, Brazil, 2021 / Efectividad de las vacunas en la prevención de la muerte por síndrome respiratório agudo grave por covid-19 en Blumenau, Brasil, 2021 / Efetividade vacinal na prevenção de óbitos em pessoas com síndrome respiratória aguda grave por covid-19 em Blumenau, 2021

ABSTRACT Objective to analyze the vaccine effectiveness in preventing deaths attributed to severe acute respiratory syndrome due to COVID-19 (SARS/COVID-19) in adults and the elderly, in Blumenau, state of Santa Catarina, Brazil, 2021. this was a population-based study conducted among individuals aged 20 years and older hospitalized with SARS/COVID-19; each death due to SARS/COVID-19 was considered a "case", and every survivor was considered a "control"; the association between vaccination status and the outcome of "death" was estimated using logistic regression, and vaccine effectiveness was estimated as (1-OR)*100. The study included 1,756 cases of SARS/COVID-19 (59.2% male, mean age of 56 years, 50.4% with elementary education, 68.4% with comorbidities and 39.1% in intensive care), of whom 398 died (cases) and 1,358 survived (controls); vaccine effectiveness was 74% and 85% (20-59 years old) and 72% and 75% (≥ 60 years old), respectively, for those who were partially vaccinated and fully vaccinated. Conclusion vaccines proved to be effective in reducing case fatality ratio due to SARS/COVID-19 in individuals ≥ 20 years old.

RESUMEN Objetivo analizar la efectividad de la vacuna para prevención de muertes por SRAG-COVID en adultos y ancianos de Blumenau, Santa Catarina, Brasil, 2021. Método estudio de base poblacional con personas hospitalizadas por SRAG-COVID mayores de 20 años; las muertes por SRAG-COVID se consideraron casos y todos los supervivientes, controles; la asociación entre el estado de vacunación y la muerte se estimó mediante regresión logística; la efectividad de la vacuna se estimó por (1-OR)*100. Resultados participaram do estudo 1.756 casos de SRAG-COVID (59,2% del sexo masculino, edad media de 56 años, 50,4% con estudios primarios, 68,4% con comorbilidades y 39,1% en cuidados intensivos), dos quais 398 foram a óbito (casos) e 1.358 sobreviveram (controles); la efectividad de la vacuna fue del 74% y el 85% (20 a 59 años) y del 72% y el 75% (60 y más años), entre los que tenían vacunación parcial y completa, respectivamente. Conclusión las vacunas fueran efectivas para reducir la letalidad del SRAG-covid.

RESUMO Objetivo Analisar a efetividade vacinal na prevenção de óbitos atribuídos a síndrome respiratória aguda grave por covid-19 (SRAG-covid) em adultos e idosos, em Blumenau, Santa Catarina, Brasil, 2021. Métodos Estudo populacional, entre maiores de 20 anos de idade internados por SRAG-covid; considerou-se "caso" cada óbito por SRAG-covid, e "controle", todo sobrevivente; estimou-se a associação entre a condição vacinal e o desfecho "óbito" por regressão logística, e a efetividade vacinal, por (1-OR)*100. Resultados Participaram do estudo 1.756 casos de SRAG-covid (59,2% do sexo masculino, idade média de 56 anos, 50,4% com ensino fundamental, 68,4% com comorbidades e 39,1% em cuidado intensivo), dos quais 398 foram a óbito (casos) e 1.358 sobreviveram (controles); a efetividade vacinal foi de 74% e 85% (20-59 anos) e de 72% e 75% (≥ 60 anos), respectivamente, para quem possuía vacinação parcial e vacinação completa. Conclusão Vacinas mostraram-se efetivas na redução da letalidade por SRAG-covid em indivíduos com idade ≥ 20 anos.

Alternative therapies for viral infections caused by SARS-Cov-2 / Terapias alternativas para infecções virais causadas pelo SARS-Cov-2

Abstract Introduction The relevance of the studied topic lies in the complexity of the treatment of infection caused by SARS-CoV-2. Objective To discuss the potential advantages and disadvantages of alternative treatments compared to conventional medical approaches, and to highlight the importance of collaborative communication between patients and healthcare providers in making informed decisions about alternative treatments of the SARS-CoV-2 virus. Methods The research methodology employed literature analysis methods, including bibliographic and bibliosemantic approaches. The study used theoretical, systematic, and statistical methods, including analysis, synthesis, generalization, interpretation, classification, and meta-analysis to explore alternative treatments for SARS-CoV-2 infections, their interrelationships, and statistical trends in incidence. Results The study identifies diverse alternative therapies for treating SARS-CoV-2 infections, highlighting herbal medicine, acupuncture, reflexology, biohacking, homoeopathy, and magnetotherapy. It underscores the potential benefits of herbal remedies like garlic, ginger, chamomile, and honeysuckle, as well as vitamins (C, D, B12) and minerals (zinc, selenium) in managing COVID-19 symptoms. Conclusion While of-fering holistic benefits, these therapies warrant cautious consideration due to limited scientific backing and potential interactions. Cultural understanding, patient-provider dialogue, and informed choices are key in harnessing the potential of alternative medicine along-side conventional approaches for managing COVID-19 challenges.

Resumo Introdução A relevância do tema estudado reside na comple-xidade do tratamento da infeção causada pelo SARS-CoV-2. Objetivo Discutir as potenciais vantagens e desvantagens dos tratamentos alternativos em comparação com as abordagens médicas convencionais e realçar a importância da comunicação colaborativa entre os doentes e os prestadores de cuidados de saúde na tomada de decisões informadas sobre os tratamentos alternativos do vírus SARS-CoV-2. Métodos A metodologia de investigação utilizou métodos de análise da literatura, incluindo abordagens bibliográficas e bibliosemânticas. O estudo utilizou métodos teóricos, sistemáticos e estatísticos, incluindo análise, síntese, generalização, interpretação, classificação e meta-aná-lise para explorar tratamentos alternativos para as infecções por SARS-CoV-2, suas inter-relações e tendências estatísticas da incidência. Resultados O estudo identifica diversas terapias alternativas para o tratamento das infecções por SARS-CoV-2, destacando a fitoterapia, a acupunctura, a reflexologia, o biohacking, a homeopatia e a magnetoterapia. Sublinha os potenciais benefícios dos remédios à base de plantas como o alho, o gengibre, a camomila e a madressilva, bem como das vitaminas (C, D, B12) e dos minerais (zinco, selénio) na gestão dos sintomas da COVID-19. Conclusão Embora ofereçam benefícios holísticos, estas terapias devem ser consideradas com cautela devido ao apoio científico limitado e às potenciais interações. A compreensão cultural, o diálogo paciente-prove-dor e as escolhas informadas são fundamentais para aproveitar o potencial da medicina alternativa juntamente às abordagens convencionais para gerir os desafios da COVID-19.

Luz UVC como estratégia de desinfecção do ar e superfícies hospitalares / Luz UV-C como estrategia de desinfección del aire y superficies hospitalarias / UVC light as a strategy for disinfection of hospital air and surfaces

Resumo Objetivo Avaliar a eficácia antimicrobiana de um dispositivo fixo emissor de luz UV-C na desinfecção de diferentes superfícies do ambiente hospitalar e sua eficácia antifúngica na qualidade do ar. Métodos Estudo quase-experimental realizado em uma unidade de internação hospitalar, que utilizou o Bioamostrador de ar Andersen® de seis estágios para análise do ar; e na avaliação das superfícies, utilizaram-se três suspensões de microrganismos (Acinetobacter sp. MDR, Escherichia coli e Klebsiella pneumoniae produtora de KPC) para contaminar o ambiente. Para ambos foram feitas coletas pré (controle) e pós-acionamento da luz UV-C (teste). Resultados Na avaliação do ar houve uma redução importante da contagem de colônias após a luz UV-C e não foram encontrados fungos patogênicos ou toxigênicos em nenhum dos dois momentos. Em relação à desinfecção das superfícies, nenhum crescimento bacteriano foi observado após a intervenção da luz, demonstrando 100% de inativação bacteriana nas condições testadas. Conclusão A utilização da tecnologia com emissão de luz UV-C fixa foi eficaz e pode ser considerada uma intervenção promissora para protocolos de desinfecção de superfícies hospitalares.

Resumen Objetivo Evaluar la eficacia antimicrobiana de un dispositivo fijo emisor de luz UV-C para la desinfección de diferentes superficies del ambiente hospitalario y su eficacia antifúngica en la calidad del aire. Métodos Estudio cuasi experimental realizado en una unidad de internación hospitalaria, en que se utilizó el biomuestreador de aire Andersen® de seis etapas para el análisis del aire. En el análisis de las superficies, se utilizaron tres suspensiones de microorganismos (Acinetobacter sp. MDR, Escherichia coli y Klebsiella pneumoniae productora de KPC) para contaminar el ambiente. En ambos se tomó una muestra antes (control) y después de accionar la luz UV-C (prueba). Resultados En el análisis del aire hubo una reducción importante del recuento de colonias después de la luz UV-C y no se encontraron hongos patógenos ni toxigénicos en ninguno de los dos momentos. Con relación a la desinfección de las superficies, no se observó ningún crecimiento bacteriano después de la intervención de la luz, lo que demuestra un 100 % de inactivación bacteriana en las condiciones analizadas. Conclusión El uso de la tecnología con emisión de luz UV-C fija fue eficaz y puede ser considerada una intervención prometedora para protocolos de desinfección de superficies hospitalarias.

Abstract Objective To evaluate a fixed UV-C light emitting device for its antimicrobial effectiveness in the disinfection of distinct surfaces and its antifungal effectiveness on air quality in the hospital environment. Methods This quasi-experimental study was conducted in a hospital inpatient unit, in which a six-stage air Biosampler (Andersen®) was used for air analysis. In the evaluation of surfaces, three suspensions of microorganisms (Acinetobacter sp. multidrug-resistant, Escherichia coli, and KPC-producing Klebsiella pneumoniae) were used to contaminate the environment. In both evaluations, pre- (control) and post-activation of UV-C light (test) collections were made. Results In the air evaluation, an important reduction was observed in the colony count after irradiation with UV-C light, and pathogenic or toxigenic fungi were not found in either of the two moments. Regarding the disinfection of surfaces, no bacterial growth was observed after the application of UV-C light, showing 100% bacterial inactivation under the tested conditions. Conclusion The use of fixed UV-C light emission technology was effective and can be considered a promising intervention for hospital surface disinfection protocols.

Uma revisão integrativa a respeito de métodos contraceptivos / An integrative review on contraceptive methods / Una revisión integrativa de los métodos anticonceptivos

Os métodos contraceptivos desempenham um papel vital na saúde sexual e reprodutiva, oferecendo opções que permitem o planejamento familiar e a prevenção de gravidezes indesejadas. Este artigo busca descrever os benefícios e desvantagens dos principais anticoncepcionais presentes na atualidade por meio de uma revisão integrativa da literatura, que buscou identificar os achados científicos publicados nos últimos 10 anos (2013 a fevereiro de 2023). A seleção de artigos foi feita nas bases eletrônicas de dados da PubMed, BVS, SciELO e no Google Acadêmico. Para a realização da revisão integrativa foi estabelecida a pergunta norteadora, para possibilitar a busca na base dados: Quais os benefícios e as desvantagens dos anticoncepcionais adesivo combinado, anel vaginal, sistema intrauterino de liberação de Levonorgestrel (SIU-LNG), contracepção de emergência (pílula de emergência), implante hormonal e anticoncepcional oral (ACO). Um dos pontos mais notáveis nesta revisão foi a grande variedade de métodos contraceptivos e suas peculiaridades, que se adequam à necessidade da usuária, sendo, portanto, preciso uma análise cuidadosa do método a ser escolhido. Outro ponto de destaque, foi que apesar dos benefícios dos contraceptivos, também estão presentes os efeitos adversos e possíveis complicações, além das precauções em sua utilização.

Contraceptive methods play a vital role in sexual and reproductive health, offering options that allow for family planning and the prevention of unwanted pregnancies. This article seeks to describe the benefits and disadvantages of the main contraceptives currently available through an integrative literature review, which sought to identify scientific findings published in the last 10 years (2013 to February 2023). The selection of articles was made in the electronic databases of PubMed, VHL, SciELO and Google Scholar. To carry out the integrative review, the guiding question was established, to enable the search in the database: What are the benefits and disadvantages of contraceptives combined patch, vaginal ring, Levonorgestrel-releasing intrauterine system (LNG-IUS), emergency contraception (emergency pill), hormonal implant and oral contraceptive (OC). One of the most notable points in this review was the wide variety of contraceptive methods and their peculiarities, which adapt to the user's needs, therefore requiring a careful analysis of the method to be chosen. Another highlight was that despite the benefits of contraceptives, adverse effects and possible complications are also present, in addition to precautions in their use.

Los métodos anticonceptivos desempeñan un papel vital en la salud sexual y reproductiva, ofreciendo opciones que permiten la planificación familiar y la prevención de embarazos no deseados. Este artículo busca describir los beneficios y desventajas de los principales anticonceptivos actualmente disponibles a través de una revisión integrativa de la literatura, que buscó identificar hallazgos científicos publicados en los últimos 10 años (2013 a febrero de 2023). La selección de artículos se realizó en las bases de datos electrónicas PubMed, BVS, SciELO y Google Scholar. Para realizar la revisión integradora se estableció la pregunta orientadora, para posibilitar la búsqueda en la base de datos: Cuáles son los beneficios y desventajas de los anticonceptivos combinados parche, anillo vaginal, sistema intrauterino liberador de levonorgestrel (SIU-LNG), anticoncepción de emergencia (emergencia píldora), implante hormonal y anticonceptivo oral (AO). Uno de los puntos más destacables de esta revisión fue la gran variedade de métodos anticonceptivos y sus peculiaridades, que se adaptan a las necesidades del usuario, requiriendo por tanto un análisis cuidadoso del método a elegir. Otro destaque fue que a pesar de los beneficios de los anticonceptivos, también están presentes efectos adversos y posibles complicaciones, además de precauciones en su uso.

Effectiveness and safety of injectable PCSK9 inhibitors in dyslipidaemias' treatment and cardiovascular disease prevention: An overview of 86 systematic reviews and a network metaanalysis.

OBJECTIVE: Multiple systematic reviews (SR) have been performed on the effects of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i), often providing conflicting findings. This overview and network meta-analysis (NMA) aimed to summarize SR findings on the efficacy and safety of PCSK9i and provide an updated NMA. MATERIALS AND METHODS: MEDLINE (Pubmed), Scopus, Cochrane, Epistemonikos and Google Scholar were searched from inception to September 21, 2023 for SRs of randomized controlled trials (RCTs) and from January 1, 2020 to September 21, 2023 for additional RCTs. Double-independent study selection, data extraction and quality assessment were performed. Qualitative analysis was performed for SRs and a frequentist random-effects model NMA was performed for RCTs. RESULTS: Totally, 86 SRs and 76 RCTs were included. Alirocumab (77/86 [90%]) and evolocumab (73/86 [85%]) were mostly analyzed. Associations from SRs (35/42 [83%]) and the updated NMA indicated PCSK9i benefit on major adverse cardiovascular events (MACEs). Reductions were also noted for cerebrovascular events (47/66 [71%]), coronary revascularization (29/33 [88%]) and myocardial infarction (41/63 [65%]). Alirocumab was associated with reductions on all-cause mortality (RR=0.82, 95%CI [0.72,0.94]). Data on any CV event reduction were conflicting (7/16 [44%]). Inclisiran appeared effective only on MACEs (RR=0.76, 95%CI [0.61,0.94]). No reductions in heart failure were observed (0/16). No increases were identified between PCSK9i and any (0/35) or serious adverse events (0/52). However, PCSK9i were associated with injection-site reactions (20/28 [71%]). CONCLUSION: PCSK9i appeared to be effective in CV outcomes and their clinical application was generally safe.

Tislelizumab, a novel PD-1 monoclonal antibody in urothelial cancer: A real-world study.

OBJECTIVE: Tislelizumab, a monoclonal antibody against programed death protein-1 (PD-1), has shown encouraging antitumor activity in urothelial cancer. This study was designed to assess the efficacy and safety of tislelizumab in urotelial cancer in a real-world setting. METHODS: The study was a real-world retrospective study undertaken at Liaoning Cancer Hospital & Institute, China. Eligible patients were ≥18 years. Patients received 200-mg tislelizumab monotherapy intravenously every 3 weeks until the disease progressed to intolerable toxicity. Outcomes included an objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety. RESULTS: Between March 2020 and December 2022, 33 patients were enrolled. The median follow-up was 10.17 (IQR 5.73-12.47) months. Of all 33 patients, ORR and DCR were 30.30% (95% CI 15.6%-48.7%) and 42.42% (95% CI 25.48%-60.78%), respectively. The median PFS was 5.73 (95% CI 3.27-13.00) months, with a 12-month PFS rate of 31.90% (95% CI 19.20%-53.00%). The median OS was 17.7 (95% CI 12.80-not reach) months, with a 12-month OS rate of 67.50% (95% CI 52.70%-86.40%). Eleven (33.33%) and 8 (24.24%) experienced ≥grade 3 treatment-related adverse events (TRAEs) and immune-related Aes, respectively. No treatment-related deaths occurred. CONCLUSION: The excellent efficacy and controllable safety of tislelizumab in locally advanced or metastatic urothelial cancer suggest that it may be a promising therapeutic option for this population.

A multi-centre, open-label, prospective, observational study to assess the safety of a nifedipine oral solution in the treatment of preterm labor / Estudio multicéntrico, de diseño abierto, prospectivo y observacional para evaluar la seguridad de una solución oral de nifedipino en el tratamiento del parto prematuro

Objective: To analyze the safety profile of a nifedipine oral solution in the treatment of preterm labor (PTL). Methods: A multi-center, open-label, prospective, single-arm, observational study was conducted in 500 women with PTL to whom a nifedipine oral solution was prescribed according to its Summary of Product Characteristics. Safety profile and tolerability of oral administration of nifedipine solution during routine clinical practice was assessed as the primary objective of the study and treatment efficacy as secondary objective. Results: No severe adverse events were reported among these women, including severe hypotension. Eight patients (2.3%) reported adverse reactions of moderate intensity, and in 0.9% of the patients (3 cases), these adverse reactions caused the discontinuation of the treatment. Conclusions: The results of this study show that nifedipine oral solution exhibits an excellent safety profile used as a tocolytic treatment in women with PTL.(AU)

Objetivo: Analizar el perfil de seguridad de una solución oral de nifedipino en el tratamiento del parto prematuro (PP). Métodos: Se llevó a cabo un estudio observacional, prospectivo, de diseño abierto, de rama única y multicéntrico en 500 mujeres que presentaban un PP, a las que se les administró una solución oral de nifedipino según la ficha técnica del producto. El perfil de seguridad y la tolerancia de la solución oral de nifedipino, en el contexto de la práctica clínica rutinaria, fueron evaluados como objetivo primario del estudio, y la eficacia del tratamiento, como objetivo secundario. Resultados: No se notificaron efectos adversos graves, incluyendo hipotensión severa. Ocho pacientes (2,3%) presentaron reacciones adversas de intensidad moderada, y en el 0,9% de las pacientes (3 casos) estos efectos adversos provocaron la discontinuación del tratamiento. Conclusiones: Los resultados de este estudio muestran que la solución oral de nifedipino dispone de un excelente perfil de seguridad para su uso como tocolítico en el tratamiento de mujeres con PP.(AU)

XV Reunión Post-ECTRIMS: revisión de las novedades presentadas en el Congreso ECTRIMS 2022 (II) / 15th Post-ECTRIMS Meeting: a review of the latest developments presented at the 2022 ECTRIMS Congress (Part II)

Introducción: El 4 y el 5 de noviembre se celebró en Madrid la Reunión Post-ECTRIMS, en la que neurólogos expertos en esclerosis múltiple resumieron las principales novedades presentadas en el congreso de ECTRIMS 2022, celebrado entre el 26 y el 28 de octubre en Ámsterdam. Objetivo: Sintetizar las ponencias que tuvieron lugar en la Reunión Post-ECTRIMS, en un artículo desglosado en dos partes. Desarrollo: En esta segunda parte, se presentan las novedades sobre las estrategias terapéuticas de escalado y desescalado de los tratamientos modificadores de la enfermedad (TME), cuándo y a quién iniciar o cambiar a TME de alta eficacia, la definición de fracaso terapéutico, la posibilidad de tratar el síndrome radiológico asilado, el futuro del tratamiento personalizado y la medicina de precisión, la eficacia y seguridad del autotrasplante de células madre hematopoyéticas, diferentes aproximaciones en el diseño de ensayos clínicos y en las medidas de resultados para evaluar TME en fases progresivas, retos en el diagnóstico y tratamiento del deterioro cognitivo, y tratamiento en situaciones especiales (embarazo, comorbilidad y personas mayores). Además, se muestran los resultados de algunos de los últimos estudios realizados con cladribina oral y evobrutinib presentados en el ECTRIMS 2022.(AU)

Introduction: On 4 and 5 November 2022, Madrid hosted the 15th edition of the Post-ECTRIMS Meeting, where neurologists specialised in multiple sclerosis outlined the latest developments presented at the 2022 ECTRIMS Congress, held in Amsterdam from 26 to 28 October. Aim: To synthesise the content presented at the 15th edition of the Post-ECTRIMS Meeting, in an article broken down into two parts. Development: This second part describes the new developments in terms of therapeutic strategies for escalation and de-escalation of disease-modifying therapies (DMT), when and in whom to initiate or switch to highly effective DMT, the definition of therapeutic failure, the possibility of treating radiologically isolated syndrome and the future of personalised treatment and precision medicine. It also considers the efficacy and safety of autologous haematopoietic stem cell transplantation, different approaches in clinical trial design and outcome measures to assess DMT in progressive stages, challenges in the diagnosis and treatment of cognitive impairment, and treatment in special situations (pregnancy, comorbidity and the elderly). In addition, results from some of the latest studies with oral cladribine and evobrutinib presented at ECTRIMS 2022 are shown.(AU)