Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

Validación de un instrumento de medición de cuidados según dependencia y riesgo en pacientes en terapia de hemodiálisis crónica

Los instrumentos de categorización de pacientes son útiles porque permiten asignar los profesionales y recursos materiales de acuerdo con el perfil real de los pacientes. El objetivo del presente estudio es adecuar y validar el instrumento “Categorización de usuarios según dependencia y riesgo de cuidados” (CUDYR) en hemodiálisis crónica (HDC). El instrumento para pacientes en HDC se denominó “CUDYR-DIAL” y quedó constituido por dos subescalas y catorce ítems. La muestra estuvo conformada por 150 pacientes seleccionados en forma estratificada y al azar de cinco unidades de diálisis, a los que se les aplicó un total de 620 veces el CUDYR-DIAL. Se encontró que todos los ítems muestran correlaciones significativas (> 0,3) con el puntaje total obtenido en la escala, y que la confiabilidad de la escala se mantiene estable al ir eliminando uno a uno los ítems, fluctuando entre 0,86 y 0,87. La confiabilidad total del instrumento muestra un alfa de Cronbach de 0,878. Los usuarios en HDC presentan cuatro perfiles de dependencia (parcial a total) y riesgo (mediano a alto). Se concluye que el instrumento CUDYR-DIAL presenta una buena confiabilidad y constituye un aporte para la categorización de pacientes en HDC según dependencia y riesgo.   DOI: 10.5294/aqui.2014.14.4.

Validação de um instrumento de medição de cuidados segundo dependência e risco em pacientes em terapia de hemodiálise crônica

nstruments to categorize patients are useful because they make it possible to allocate professionals and material resources according to the actual profile of the patient. The purpose of this study was to adapt and validate an instrument known as "Categorizing Users According to Care Dependency and Risk" (CUDYR) in Chronic Hemodialysis (CHD). The instrument for patients in CHD was called "CUDYRDIAL" and was comprised of two subscales and fourteen items. The sample consisted of 150 patients from five dialysis units who were selected in a stratified manner, at random. The CUDYR-DIAL instrument was applied to them a total of 620 times. All the items showed significant correlations (&gt; 0.3) with the total score on the scale, and the reliability of the scale remained stable when the items were eliminated one by one, fluctuating between 0.86 and 0.87. The overall reliability of the instrument shows a Cronbach's alpha of 0.878. Users in HDC fit four profiles in terms of dependency (partial to complete) and risk (medium to high). It was concluded the reliability of the CUDYR-DIAL instrument is good and it represents a contribution to categorizing patients according HDC dependence and risk.Los instrumentos de categorización de pacientes son útiles porque permiten asignar los profesionales y recursos materiales de acuerdo con el perfil real de los pacientes. El objetivo del presente estudio es adecuar y validar el instrumento “Categorización de usuarios según dependencia y riesgo de cuidados” (CUDYR) en hemodiálisis crónica (HDC). El instrumento para pacientes en HDC se denominó “CUDYR-DIAL” y quedó constituido por dos subescalas y catorce ítems. La muestra estuvo conformada por 150 pacientes seleccionados en forma estratificada y al azar de cinco unidades de diálisis, a los que se les aplicó un total de 620 veces el CUDYR-DIAL. Se encontró que todos los ítems muestran correlaciones significativas (&gt; 0,3) con el puntaje total obtenido en la escala, y que la confiabilidad de la escala se mantiene estable al ir eliminando uno a uno los ítems, fluctuando entre 0,86 y 0,87. La confiabilidad total del instrumento muestra un alfa de Cronbach de 0,878. Los usuarios en HDC presentan cuatro perfiles de dependencia (parcial a total) y riesgo (mediano a alto). Se concluye que el instrumento CUDYR-DIAL presenta una buena confiabilidad y constituye un aporte para la categorización de pacientes en HDC según dependencia y riesgo.  DOI: 10.5294/aqui.2014.14.4.3Os instrumentos de categorização de pacientes são úteis porque permitem designar os profissionais e recursos materiais de acordo com o perfil real dos pacientes. O objetivo do presente estudo é adequar e validar o instrumento "Categorização de usuários segundo dependência e risco de cuidados" (CUDYR) em hemodiálise crônica (HDC). O instrumento para pacientes em HDC se denominou "CUDYRDIAL" e ficou constituído por duas subescalas e quatorze itens. A amostra foi conformada por 150 pacientes selecionados em forma estratificada e aleatória de cinco unidades de diálise, aos quais foi aplicado um total de 620 vezes o CUDYR-DIAL. Constatou-se que todos os itens mostram correlações significativas (&gt; 0,3) com a pontuação total obtida na escala, e que a confiabilidade da escala se mantém estável ao ir eliminando um a um os itens, flutuando entre 0,86 e 0,87. A confiabilidade total do instrumento mostra um alfa de Cronbach de 0,878. Os usuários em HDC apresentam quatro perfis de dependência (parcial a total) e risco (médio a alto). Conclui-se que o instrumento CUDYR-DIAL apresenta uma boa confiabilidade e constitui uma contribuição para a categorização de pacientes em HDC segundo dependência e risco

Validação de um instrumento de medição de cuidados segundo dependência e risco em pacientes em terapia de hemodiálise crônica

12 páginasLos instrumentos de categorización de pacientes son útiles porque permiten asignar los profesionales y recursos materiales de acuerdo con el perfil real de los pacientes. El objetivo del presente estudio es adecuar y validar el instrumento "Categorización de usuarios según dependencia y riesgo de cuidados" (CUDYR) en hemodiálisis crónica (HDC). El instrumento para pacientes en HDC se denominó "CUDYR-DIAL" y quedó constituido por dos subescalas y catorce ítems. La muestra estuvo conformada por 150 pacientes seleccionados en forma estratificada y al azar de cinco unidades de diálisis, a los que se les aplicó un total de 620 veces el CUDYR-DIAL. Se encontró que todos los ítems muestran correlaciones significativas (> 0,3) con el puntaje total obtenido en la escala, y que la confiabilidad de la escala se mantiene estable al ir eliminando uno a uno los ítems, fluctuando entre 0,86 y 0,87. La confiabilidad total del instrumento muestra un alfa de Cronbach de 0,878. Los usuarios en HDC presentan cuatro perfiles de dependencia (parcial a total) y riesgo (mediano a alto). Se concluye que el instrumento CUDYR-DIAL presenta una buena confiabilidad y constituye un aporte para la categorización de pacientes en HDC según dependencia y riesgo

Validación de un instrumento de medición de cuidados según dependencia y riesgo en pacientes en terapia de hemodiálisis crónica

Los instrumentos de categorización de pacientes son útiles porque permiten asignar los profesionales y recursos materiales de acuer- do con el perfil real de los pacientes. El objetivo del presente estudio es adecuar y validar el instrumento “ Categorización de usuarios según dependencia y riesgo de cuidados ” (CUDYR) en hemodiálisis crónica (HDC). El instrumento para pacientes en HDC se denominó “ CUDYR-DIAL ” y quedó constituido por dos subescalas y catorce ítems. La muestra estuvo conformada por 150 pacientes seleccionados en forma estratificada y al azar de cinco unidades de diálisis, a los que se les aplicó un total de 620 veces el CUDYR-DIAL. Se encontró que todos los ítems muestran correlaciones significativas (> 0,3) con el puntaje total obtenido en la escala, y que la confiabilidad de la escala se mantiene estable al ir eliminando uno a uno los ítems, fluctuando entre 0,86 y 0,87. La confiabilidad total del instrumento muestra un alfa de Cronbach de 0,878. Los usuarios en HDC presentan cuatro perfiles de dependencia (parcial a total) y riesgo (mediano a alto). Se concluye que el instrumento CUDYR-DIAL presenta una buena confiabilidad y constituye un aporte para la categorización de pacientes en HDC según dependencia y riesgo

NEOTROPICAL CARNIVORES: a data set on carnivore distribution in the Neotropics

Mammalian carnivores are considered a key group in maintaining ecological health and can indicate potential ecological integrity in landscapes where they occur. Carnivores also hold high conservation value and their habitat requirements can guide management and conservation plans. The order Carnivora has 84 species from 8 families in the Neotropical region: Canidae; Felidae; Mephitidae; Mustelidae; Otariidae; Phocidae; Procyonidae; and Ursidae. Herein, we include published and unpublished data on native terrestrial Neotropical carnivores (Canidae; Felidae; Mephitidae; Mustelidae; Procyonidae; and Ursidae). NEOTROPICAL CARNIVORES is a publicly available data set that includes 99,605 data entries from 35,511 unique georeferenced coordinates. Detection/non-detection and quantitative data were obtained from 1818 to 2018 by researchers, governmental agencies, non-governmental organizations, and private consultants. Data were collected using several methods including camera trapping, museum collections, roadkill, line transect, and opportunistic records. Literature (peer-reviewed and grey literature) from Portuguese, Spanish and English were incorporated in this compilation. Most of the data set consists of detection data entries (n = 79,343; 79.7%) but also includes non-detection data (n = 20,262; 20.3%). Of those, 43.3% also include count data (n = 43,151). The information available in NEOTROPICAL CARNIVORES will contribute to macroecological, ecological, and conservation questions in multiple spatio-temporal perspectives. As carnivores play key roles in trophic interactions, a better understanding of their distribution and habitat requirements are essential to establish conservation management plans and safeguard the future ecological health of Neotropical ecosystems. Our data paper, combined with other large-scale data sets, has great potential to clarify species distribution and related ecological processes within the Neotropics. There are no copyright restrictions and no restriction for using data from this data paper, as long as the data paper is cited as the source of the information used. We also request that users inform us of how they intend to use the data

Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo

BACKGROUND: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagon-like peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated. METHODS: ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk. The primary efficacy end point is a composite of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Data are systematically collected for safety outcomes, including hypoglycemia, pancreatitis, and malignancy. RESULTS: Enrollment began in July 2010 and ended in August 2013; 6,068 patients from 49 countries were randomized. Of these, 69% are men and 75% are white; at baseline, the mean ± SD age was 60.3 ± 9.7 years, body mass index was 30.2 ± 5.7 kg/m(2), and duration of T2DM was 9.3 ± 8.2 years. The qualifying ACS was a myocardial infarction in 83% and unstable angina in 17%. The study will continue until the positive adjudication of the protocol-specified number of primary CV events. CONCLUSION: ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk

Guidelines for the use and interpretation of assays for monitoring autophagy (4th edition)

In 2008, we published the first set of guidelines for standardizing research in autophagy. Since then, this topic has received increasing attention, and many scientists have entered the field. Our knowledge base and relevant new technologies have also been expanding. Thus, it is important to formulate on a regular basis updated guidelines for monitoring autophagy in different organisms. Despite numerous reviews, there continues to be confusion regarding acceptable methods to evaluate autophagy, especially in multicellular eukaryotes. Here, we present a set of guidelines for investigators to select and interpret methods to examine autophagy and related processes, and for reviewers to provide realistic and reasonable critiques of reports that are focused on these processes. These guidelines are not meant to be a dogmatic set of rules, because the appropriateness of any assay largely depends on the question being asked and the system being used. Moreover, no individual assay is perfect for every situation, calling for the use of multiple techniques to properly monitor autophagy in each experimental setting. Finally, several core components of the autophagy machinery have been implicated in distinct autophagic processes (canonical and noncanonical autophagy), implying that genetic approaches to block autophagy should rely on targeting two or more autophagy-related genes that ideally participate in distinct steps of the pathway. Along similar lines, because multiple proteins involved in autophagy also regulate other cellular pathways including apoptosis, not all of them can be used as a specific marker for bona fide autophagic responses. Here, we critically discuss current methods of assessing autophagy and the information they can, or cannot, provide. Our ultimate goal is to encourage intellectual and technical innovation in the field