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

Ecology meets archaeology: Past, present and future vegetation-derived ecosystems services from the Nuragic Sardinia (1700–580 BCE)

Incorporating archaeology within the ecosystem services (ES) framework can offer decision-makers lessons from the past and a broader sustainability perspective. Given the claimed archaeology-ES link, the island of Sardinia (Italy) offers an unparalleled opportunity where a unique archaeological heritage occurs in an area of high biodiversity value. More than 5000 nuraghi, megalithic edifices distinctive of the Nuragic civilization (1700–580 BCE), are still present on the island. By crossing the map of Vegetation Series (VS) with nuraghi occurrences, we aimed at acquiring a long-term perspective on the interactions between Nuragic people and the vegetation as ES provider, so as to enrich our understanding of the past and the present, and potentially inform future practice for the region of Sardinia. A VS is here intended as a hypothesis of a succession of plant communities that can potentially succeed each other over time in a particular land unit. The vegetation-derived ES represented a driving force in the land occupation strategies of the Nuragic people, who preferred, for their settlements, the mesophiluos cork oak VS and secondary the deciduous broad-leaved ones, which, with fresh climatic conditions on fertile substrates and gentle slopes on effusive magmatic rocks, can provide land for grazing and agriculture. Conversely, the Nuragic land occupation strategies shaped the VS, transforming the landscape into agro-silvo-pastoral systems. Our results suggest that the origin of the present agro-silvo-pastoral landscapes (i.e. Pascolo arborato/Dehesa) in Sardinia could be traced back to the Nuragic civilization. The interaction between humans and vegetation in Sardinia is ancient, reciprocal and dynamic. This interaction is crucial for the survival of the present agro-silvo-pastoral landscapes that represent important suppliers of provisioning, regulating and cultural ES. Among others, these landscapes are a good example of intimate and sustainable relationships between people and nature and provide a marked sense of place and identity for Sardinia inhabitants. This transdisciplinary approach linking plant ecology with archaeology offered archaeology a better understanding of the environmental settings and subsistence of the Nuragic civilization and provided plant ecology with a long-term perspective on human-vegetation interactions. Read the free Plain Language Summary for this article on the Journal blog