36 research outputs found
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
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Helmuth Plessner and <i>The Delayed Nation</i>
Helmuth Plessner’s The Delayed Nation was a key text in the Sonderweg narrative that dominated the writing of German history from the later 1950s to the mid-1980s: the idea that the disaster of the Third Reich and the Holocaust could be explained in terms of Germany’s problematic path to modernity since the Middle Ages. The book had originally been published under a rather prolix title in Zurich in 1935 when Plessner was an émigré in the Netherlands. It made little impact then, and only attracted attention from 1959 under a short title which seemed to capture the essence of the emerging left-liberal view of the disastrous course of German history. The more accessible title in reality masked an extremely complex book which did not sit easily with the social history preoccupations of the avant-garde of post-war German historians. Plessner’s history was a narrative of intellectual degeneration that placed philosophy at the heart of the German problem. Plessner’s book can only be fully understand in relation to his own philosophical and political concerns in the 1920s. Its impact in the 1960s and after derives almost entirely from its suggestive and eye-catching title. </jats:p