Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.

BACKGROUND: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. METHODS: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. FINDINGS: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. INTERPRETATION: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials

Hiperkalemia crónica, diagnóstico y manejo. Consenso colombiano

Objetivo: Generar recomendaciones para el diagnóstico, el manejo y el seguimiento de la hiperkalemia crónica. Método: Este consenso fue realizado por nefrólogos y cardiólogos siguiendo la metodología GRADE. Resultados: La hiperkalemia crónica puede definirse como una condición bioquímica, con o sin manifestaciones clínicas, caracterizada por una elevación recurrente de las concentraciones séricas de potasio que puede requerir una intervención farmacológica, no farmacológica o ambas. Puede clasificarse en leve (K+ 5,0 a 6,0 mEq/l). Su incidencia y prevalencia no han sido claramente determinadas. Se consideran factores de riesgo la enfermedad renal crónica, la insuficiencia cardiaca crónica, la diabetes mellitus, la edad ≥ 65 años, la hipertensión arterial y el tratamiento con inhibidores del sistema renina-angiotensina-aldosterona (iSRAA), entre otros. No hay consenso sobre el manejo de la hiperkalemia crónica. Se sugiere identificar y eliminar o controlar los factores de riesgo, brindar asesoramiento sobre la ingesta de potasio y, para quien esté indicado, optimizar la terapia con iSRAA, administrar aglutinantes orales del potasio y corregir la acidosis metabólica. Conclusiones: Se recomienda prestar atención al diagnóstico, el manejo y el seguimiento de la hiperkalemia crónica, en especial en los pacientes con factores de riesgo

Healthy minds on healthy airways Effects of Channel 4's 1986 mental health programme campaign

SIGLEAvailable from British Library Document Supply Centre-DSC:GPE/1212 / BLDSC - British Library Document Supply CentreGBUnited Kingdo

GLP-1Ra en el manejo de diabetes mellitus tipo 2: una revisión de revisiones sistemáticas

Introducción: La diabetes mellitus es una enfermedad crónica grave con una prevalencia mundial del 8.5% en mayores de 18 años, de los cuales el 90% pertenecen al tipo 2; una opción farmacológica para su manejo son los GLP-1Ra, los cuales tienen una eficacia en la reducción de la hemoglobina glicosilada (HbA1c) de 0.9 hasta el 1.6%. Objetivo: Sintetizar la evidencia de revisiones sistemáticas sobre la seguridad de los GLP-1Ra para desenlaces cardiovasculares y renales comparada con terapia estándar en pacientes adultos con DMT-2 y la efectividad reportada. Métodos: Se realizó una búsqueda amplia y sistemática de literatura en Medline y Ovid con métodos complementarios de búsqueda. La selección y extracción de datos fue independiente y pareada. La calidad metodológica fue evaluada con SING. Como intervención se evaluaron: Liraglutida, Lixisenatida, Albiglutida, Semaglutida, Dulaglutida, Exenatida, Taspoglutida y Efpeglenatida comparado con placebo o terapia activa. Resultados: Diecisiete estudios fueron incluidos, los cuales agruparon 47 ensayos clínicos únicos. Los resultados muestran una tendencia en el efecto protector para los desenlaces cardiovasculares y renales, pero muy pocos muestran ser estadísticamente significativos cuando se analizan individualmente las moléculas en los que también se reportan contradicciones en la dirección del efecto para algunos desenlaces cardiovasculares. Conclusiones: Los resultados deben ser interpretados con cautela daba la variabilidad y contradicción en la dirección del efecto en algunos casos. Su uso en la práctica clínica se sugiere esté orientado por las características basales de los pacientes y los resultados individuales de seguridad de cada molécula

V. Manejo del paciente con infección por SARS-CoV-2/COVID-19

La cloroquina (CQ) e hidroxicloroquina (HCQ) son fármacos antimaláricos y antiinflamatorios indicados en enfermedades como artritis reumatoidea y lupus eritematoso, se les ha documentado actividad in vitro contra SARS-CoV-2.Q4https://orcid.org/0000-0001-6396-3267Revista Nacional - IndexadaN

Consenso colombiano de expertos sobre recomendaciones informadas en la evidencia para el manejo de la infección por SARS-CoV-2/COVID-19 en adulto mayor multimorbido con enfermedad renal crónica

Introduction: SARS-CoV-2 infection is a pandemic with a significant impact on the elderly population with multiple morbidities. Objective: To develop evidence-informed recommendations for the prevention, diagnosis, and management of SARS CoV2 / COVID-19 infection in multimorbed elderly patients with chronic kidney disease, through a consensus of experts. Methodology: Based on the evidence collected through a literature review in Pubmed, Embase and scientific societies, recommendations were formulated that were submitted to the consultation of experts in nephrology, geriatrics and palliative care. The quality of evidence was evaluated with tools based on the type of document. The approved recommendations were classified according to their direction and strength. Results: Twenty-two experts declared their conflict of interest and filled out the consultation tool between August 02 and 10, 2020. The percentage of agreement for each recommendation ranged between 90.9 and 100%.Thirty-two recommendations are presented for the management of SARS-CoV-2 infection in multimorbed elderly patients with chronic kidney disease. Conclusion: The recommendations formulated guide the decision-making of health professionals involved in the care of elderly patients with chronic kidney disease and other morbidities with SARS-CoV-2 infection.Introducción: La infección por SARS-CoV-2 es una pandemia con importante impacto en población adulta mayor con múltiples morbilidades. Objetivo: Desarrollar mediante un consenso de expertos, recomendaciones informadas en evidencia para la prevención, diagnóstico y manejo de infección por SARS CoV2/COVID-19 en paciente adulto mayor multimorbido con enfermedad renal crónica. Metodología: A partir de la evidencia recolectada a través de una revisión de literatura en Pubmed, Embase y sociedades científicas, se formularon recomendaciones que fueron sometidas a la consulta de expertos en nefrología, geriatría y cuidados paliativos. La calidad de evidencia se evalúo con herramientas en función del tipo de documento. Las recomendaciones aprobadas fueron clasificadas de acuerdo a su dirección y fuerza. Resultados: Veintidós expertos declararon su conflicto de interés y diligenciaron la herramienta de consulta entre el 02 y 10 de agosto de 2020. El porcentaje de acuerdo por cada recomendación oscilo entre el 90.9 y 100%. Se presentan 32 recomendaciones para el manejo de la infección por SARS-CoV-2 en paciente adulto mayor multimorbido con enfermedad renal crónica.  Conclusión: Las recomendaciones formuladas orientan la toma de decisiones de los profesionales de la salud involucrados en la atención de pacientes mayores con enfermedad renal crónica y otras morbilidades que presentan infección por SARS-CoV-2

Consenso colombiano de expertos sobre recomendaciones informadas en la evidencia para la prevención, diagnóstico y manejo de la infección por SARS-CoV-2/COVID-19 en paciente pediátrico con enfermedad renal crónica o lesión renal aguda asociada a COVID-19

Introduction: The numbers of SARS-CoV-2 infection in the pediatric population are low so far. There is limited information about the behavior of SARS-CoV-2 in a pediatric patient with chronic kidney disease. Objective: To formulate informed recommendations to the prevention, diagnosis, and management of SARS-CoV-2 infection in pediatric patients with kidney disease or acute kidney injury associated with COVID-19 in Colombia. Methodology: A rapid systematic review was performed in Embase and Pubmed databases and scientific societies, to answer questions prioritized by clinical experts in pediatric nephrology. The quality of the evidence was evaluated with validated tools according to the type of study. The preliminary recommendations were consulted by an expert group. The agreement was defined when approval was obtained from at least 70% of the experts consulted. Results: A response was obtained from 19 experts in pediatric nephrology in Colombia, who declared the conflict of interest before the consultation. The range of agreement for the recommendations ranged from 78.9% to 100%. The recommendations did not require a second consultation. Conclusion: The evidence-based recommendations for the management of a patient with kidney disease and COVID-19 in the Colombian context are presented.Introducción: las cifras de infección por SARS-CoV-2 en población pediátrica son bajas hasta ahora. Es limitada la información acerca del comportamiento del SARS-CoV-2 en pacientes pediátricos con enfermedad renal crónica. Objetivo: formular recomendaciones informadas en evidencia para la prevención, el diagnóstico y el manejo de infección por SARS- CoV-2 en pacientes pediátricos con enfermedad renal o lesión renal aguda asociada a COVID-19 en Colombia. Metodología: se realizó una revisión sistemática rápida en bases de datos Embase y Pubmed y sociedades científicas, para dar respuesta a preguntas priorizadas por expertos clínicos en nefrología pediátrica. Se evaluó la calidad de la evidencia con herramientas validadas de acuerdo con el tipo de estudio. Las recomendaciones preliminares fueron consultadas a un colectivo experto. Se definió acuerdo cuando se obtuvo aprobación en al menos el 70% de los expertos consultados. Resultados: se obtuvo respuesta de 19 expertos en nefrología pediátrica de Colombia, quienes declararon su conflicto de interés previa consulta. El rango de acuerdo para las recomendaciones osciló entre 78,9 y 100%. Las recomendaciones no requirieron segunda consulta. Conclusión: se presentan las recomendaciones basadas en evidencia para manejo de pacientes con enfermedad renal y COVID-19 en el contexto colombiano