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

Diversidad de ma\uedz en la sierra sur de Oaxaca, M\ue9xico: conocimiento y manejo tradicional

The state of Oaxaca represents an important pool of maize in Mexico. Previous studies have indicated the presence of many local varieties and agronomic races, mainly at the Northern Sierra and Central Valleys. The Southern Sierra has not been studied, in spite of the presence of indigenous Zapotec communities, which cultivate maize, among other crops, and have preserved local varieties. The present study is focused on the following questions: Which is the maize diversity, in terms of traditional varieties and agronomic races, in the Zapotec region of Los Loxicha? Does Maize diversity follow a pattern of distribution along an altitudinal interval? Which practices promote, and maintain this diversity? To answer these questions, we conducted a study within five municipalities at the Southern part of Oaxaca. During 2007, structured interviews were applied to 930 farmers in order to obtain a descriptive process of seed management. Morphological characterization of agronomic races was based on ear specimens obtained from a sample of 375 "milpas", with 20 plants per "milpa". High levels of local maize diversity were recorder, with 36 traditional varieties belonging to 10 races. Races exhibited differences in terms of phenotypic variation, and altitudinal distribution, and some could indicate local adaptation. People practice some ancestral management of ear and seed selection, thus maintaining differentiation among varieties and agronomic races. Nevertheless, sowing many local varieties in the same field, promotes gene flow and introgression among them, maintaining, and promoting phenotypic and genetic diversity.El estado de Oaxaca representa un importante acervo de maíz en México. Estudios previos han indicado la presencia de muchas variedades locales y razas agronómicas en la Sierra Norte y Valles Centrales. La Sierra Sur ha sido poco estudiada a pesar de la presencia de comunidades indígenas zapotecas, las cuales cultivan maíz, entre otras especies, y han preservado las variedades locales. El presente estudio responde a las siguientes preguntas: ¿cuál es la diversidad de maíz en términos de variedades tradicionales y razas agronómicas en la región zapoteca de Los Loxicha?, ¿la diversidad de maíz sigue un patrón de distribución a lo largo de un gradiente altitudinal?, ¿cuáles prácticas promueven y mantienen esta diversidad? Para contestar estas preguntas se realizó un estudio en cinco municipios de la Sierra Sur de Oaxaca. Durante 2007 se aplicaron entrevistas estructuradas a 930 agricultores para describir el proceso de manejo de semilla. La caracterización morfológica de las razas agronómicas se basó en muestras de mazorcas obtenidas en 375 milpas, con 20 plantas por milpa. Se encontraron altos niveles de diversidad local de maíz, con 36 variedades tradicionales correspondientes a 10 razas agronómicas. Las razas exhibieron diferencias en términos de variación fenotípica, distribución altitudinal y algunas muestran adaptación local. Los agricultores practican algunas formas de manejo ancestral para la selección de mazorcas y semillas, manteniendo, así, ciertos niveles de diferenciación entre las variedades y las razas agronómicas. Sin embargo, al sembrar diferentes variedades dentro de la misma parcela, se promueve el flujo génico y la introgresión entre ellas, manteniendo y promoviendo la diversidad fenotípica y genética