Evolution of the use of corticosteroids for the treatment of hospitalised COVID-19 patients in Spain between March and November 2020: SEMI-COVID national registry

Objectives: Since the results of the RECOVERY trial, WHO recommendations about the use of corticosteroids (CTs) in COVID-19 have changed. The aim of the study is to analyse the evolutive use of CTs in Spain during the pandemic to assess the potential influence of new recommendations. Material and methods: A retrospective, descriptive, and observational study was conducted on adults hospitalised due to COVID-19 in Spain who were included in the SEMI-COVID- 19 Registry from March to November 2020. Results: CTs were used in 6053 (36.21%) of the included patients. The patients were older (mean (SD)) (69.6 (14.6) vs. 66.0 (16.8) years; p < 0.001), with hypertension (57.0% vs. 47.7%; p < 0.001), obesity (26.4% vs. 19.3%; p < 0.0001), and multimorbidity prevalence (20.6% vs. 16.1%; p < 0.001). These patients had higher values (mean (95% CI)) of C-reactive protein (CRP) (86 (32.7-160) vs. 49.3 (16-109) mg/dL; p < 0.001), ferritin (791 (393-1534) vs. 470 (236- 996) µg/dL; p < 0.001), D dimer (750 (430-1400) vs. 617 (345-1180) µg/dL; p < 0.001), and lower Sp02/Fi02 (266 (91.1) vs. 301 (101); p < 0.001). Since June 2020, there was an increment in the use of CTs (March vs. September; p < 0.001). Overall, 20% did not receive steroids, and 40% received less than 200 mg accumulated prednisone equivalent dose (APED). Severe patients are treated with higher doses. The mortality benefit was observed in patients with oxygen saturation </=90%. Conclusions: Patients with greater comorbidity, severity, and inflammatory markers were those treated with CTs. In severe patients, there is a trend towards the use of higher doses. The mortality benefit was observed in patients with oxygen saturation </=90%

Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial

Background Non-alcoholic steatohepatitis (NASH) is a common type of chronic liver disease that can lead to cirrhosis. Obeticholic acid, a farnesoid X receptor agonist, has been shown to improve the histological features of NASH. Here we report results from a planned interim analysis of an ongoing, phase 3 study of obeticholic acid for NASH. Methods In this multicentre, randomised, double-blind, placebo-controlled study, adult patients with definite NASH,non-alcoholic fatty liver disease (NAFLD) activity score of at least 4, and fibrosis stages F2–F3, or F1 with at least oneaccompanying comorbidity, were randomly assigned using an interactive web response system in a 1:1:1 ratio to receive oral placebo, obeticholic acid 10 mg, or obeticholic acid 25 mg daily. Patients were excluded if cirrhosis, other chronic liver disease, elevated alcohol consumption, or confounding conditions were present. The primary endpointsfor the month-18 interim analysis were fibrosis improvement (≥1 stage) with no worsening of NASH, or NASH resolution with no worsening of fibrosis, with the study considered successful if either primary endpoint was met. Primary analyses were done by intention to treat, in patients with fibrosis stage F2–F3 who received at least one dose of treatment and reached, or would have reached, the month 18 visit by the prespecified interim analysis cutoff date. The study also evaluated other histological and biochemical markers of NASH and fibrosis, and safety. This study is ongoing, and registered with ClinicalTrials.gov, NCT02548351, and EudraCT, 20150-025601-6. Findings Between Dec 9, 2015, and Oct 26, 2018, 1968 patients with stage F1–F3 fibrosis were enrolled and received at least one dose of study treatment; 931 patients with stage F2–F3 fibrosis were included in the primary analysis (311 in the placebo group, 312 in the obeticholic acid 10 mg group, and 308 in the obeticholic acid 25 mg group). The fibrosis improvement endpoint was achieved by 37 (12%) patients in the placebo group, 55 (18%) in the obeticholic acid 10 mg group (p=0·045), and 71 (23%) in the obeticholic acid 25 mg group (p=0·0002). The NASH resolution endpoint was not met (25 [8%] patients in the placebo group, 35 [11%] in the obeticholic acid 10 mg group [p=0·18], and 36 [12%] in the obeticholic acid 25 mg group [p=0·13]). In the safety population (1968 patients with fibrosis stages F1–F3), the most common adverse event was pruritus (123 [19%] in the placebo group, 183 [28%] in the obeticholic acid 10 mg group, and 336 [51%] in the obeticholic acid 25 mg group); incidence was generally mild to moderate in severity. The overall safety profile was similar to that in previous studies, and incidence of serious adverse events was similar across treatment groups (75 [11%] patients in the placebo group, 72 [11%] in the obeticholic acid 10 mg group, and 93 [14%] in the obeticholic acid 25 mg group). Interpretation Obeticholic acid 25 mg significantly improved fibrosis and key components of NASH disease activity among patients with NASH. The results from this planned interim analysis show clinically significant histological improvement that is reasonably likely to predict clinical benefit. This study is ongoing to assess clinical outcomes

Anales de Edafología y Agrobiología Tomo 44 Número 7-8

l. Suelos. Física Nuevo método para estimar la evapotranspiración potencial y el déficit de precipitación. Fórmulas para Salamanca y Zamora, por F. de Pablo, A. Egido, L. J. Rivas y J. Garmendia.-- Estudio climatológico del Valle del Guadalquivir mediante un modelo vectorial (Análisis de componentes generalizado), por R. Roman y M. C. Navarro. l. Suelos. Química Alfisoles de los Montes de Toledo. III. Perfil ultic palexeralf. Estudio mineralógico de la fracción arcilla por difracción de Rayos X y espectroscopia infrarroja, por P. Recio y M. T. García-González.-- Alfisoles de los Montes de Toledo. IV. Perfil ultic palexeralf. Estudio mineralógico de la fracción arcilla por métodos térmicos de análisis. Determinaciones analíticas elementales, por P. Recio y M. T. García-González.-- Determinación de la actividad fosfatasa en suelos gallegos. Precisiones al método de Sarathchandra y Perrot, por Ma C. Trasar Cepeda, F. Gil Sotres y F. Guitián Ojea.--Contribución al estudio de la movilización de nitrógeno en ecosistemas del centro de España, por A. García-Villaraco y F. Velasco de Pedro-- Movilización y fijación biológica de cationes en ecosistemas forestales. l. Dinámica del Ca y Mg en los horizontales superficiales del suelo, por A. García-Vilaraco.-- Electromelioration of saline-alkali soils • a review, by L. L. Somanil.-- Suelos.-Biologfa Efectos de la deforestación sobre los suelos de la comarca de Antequera (Málaga).lll. Análisis y evaluación, por R. Delgado Calvo-Flores, G. Barceló y J. Párraga.-- l. Suelos-Génesis, Clasificación y Cartografía Los xerumbrepts bajo matorral de alta montaña de la vertiente sur de Sierra Nevada (Granada), por G. Delgado Calvo-Flores, J. Párraga Martínez, E. Serrano Molina y R. Delgado Calvo-Flores.-- Aplicación de un análisis multivariante a los suelos de la Alfaguara (Sierra de Alfacar• Granada), por l. García Fernández, M. Simón Torres, A. Polo Sánchez.-- l. Suelos. Fertilidad Presence and characterization of micrococcus luteus in a bare soil, by M. A. Sagardoy.-- Soil managements and use of 15 N-Labelled fertilizer for weat in semiarid Argentina. 2, por R. A. Rosell, R. M. Martínez y K. Ch. Sommer.-- Contribución al conocimiento de la utilización del agua del suelo por las especies fores• tales (Quercus robus y Pinus pinaster) bajo clima templado húmedo, por A. Paz González y F. Díaz-Fierros Viqueira.-- Fertilizer and foliar sampling trials in two stages of development of the flower bud in the rose 'Mercedes', by C. E. Alvarez, M. Fernández, V. García and A. E. Carracedo.-- Poder fertilizante de los lodos residuales: efecto sobre el contenido total y disponibilidad de Fe, Mn, Cu, Co y Ni, por M. L. Andrade Couce, A. M ateos Beato y F. Guitián Ojea.-- Adición de lodos residuales a un suelo ácido : influencia sobre el contenido total, disponi• bilidad y absorción por el cultivo, de Zn, Pb, Cr y Cd, por M. L.Andrade Couce, M. Bao Iglesias y F. Guitián Ojea.—II. Biología Vegetal.-Nutrición Estudio comparativo de metodologías de control nutricional en plantas de pimiento cul• tivadas en invernadero bajo sistema de riego localizado, por C. F. Alcaraz, M. •A. Martínez-Cañadas, F. Martínez-Sánchez y F. Sevilla. II. Biología Vegetal. Fisiología Inducción y cultivo de callos procedentes de explantes de hipocotilo, cotiledon y ra• dicula de Erysimum scoparium, por J. F. Pérez Francés, F. Valdés, A. J. Carmona y A. C. Blesa.-- Biología Vegetal. Agrobiologfa Diversidad florística y heterogeneidad ambiental en una dehesa de Sierra Morena, por T. Marañón Arana.-- Trabajo recapitulativo Revisión monográfica de la aplicación de técnicas de microanálisis de Rayos-X en Viología Vegetal, por J. M. Pozuelo y M. R. de Felipe. BibliografíaPeer reviewe