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

Population-based nutrition study on an urban population with type 2 diabetes mellitus

Aim. The aim of our cross-sectional study was to evaluate the nutrition (or diet) habits of people with type 2 diabetes mellitus (DM) in the urban population (45–69 years) of Novosibirsk. Materials and methods. We included 1,041 people with DM and 8,095 people without DM in this study. The nutrition data were obtained via a population survey using a questionnaire to assess the frequency of food consumption within the framework of HAPIEE, an international project. Results. The prevalence of DM was 11.4% in this study population. The nutrition intake analysis showed that carbohydrate consumption in both men and women with DM was significantly lower compared with that in those without DM, while fat and protein intake were significantly higher. In men with type 2 DM, the proportions of black bread, vegetables, dairy products and meat in the diet were significantly higher, while the proportions of white bread and sweets in the diet were significantly lower compared with their counterparts without DM. Women with DM also had significantly higher proportions of black bread, vegetables, dairy products, meat and fish in the diet and lower proportions of white bread, potatoes and sweets in the diet than the controls. The proportions of fruit, eggs and alcohol intake did not differ between the groups for both men and women. In men, there was also no difference in the proportions of potatoes, vegetables and fish intake between the groups. Conclusion. The diets of both patients with DM and the general population in Novosibirsk are not well balanced