Finerenone in Patients with Chronic Kidney Disease and Type 2 Diabetes: FIDELIO-DKD subgroup from China

Background: This prespecified subgroup analysis of the FIDELIO-DKD trial aimed to evaluate the efficacy and safety of finerenone in patients with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2DM) in China. Methods: Three hundred and seventy-two participants were recruited from 67 centers in China and randomized 1:1 to oral finerenone or placebo with standard therapy for T2DM. The primary composite outcome included kidney failure, sustained decrease of estimated glomerular filtration rate (eGFR) ≥ 40% from baseline over at least 4 weeks, or renal death. The key secondary composite outcome included death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Results: After a median follow-up of 30 months, the finerenone group showed a relative risk reduction (RRR) of 41% (hazard ratio [HR]=0.59, 95% confidence interval [CI], 0.39 to 0.88; p=0.009) for the primary composite outcome compared with placebo, consistent across its components with treatment benefits with finerenone. Based on an absolute between-group difference of 12.2% after 30 months, the number of patients who needed to be treated (NNT) with finerenone to prevent one primary outcome event was eight (95%CI: 4 to 84). For the key secondary composite outcome, the finerenone group showed a RRR of 25% (HR=0.75, 95% CI, 0.38 to 1.48; p=0.408). Adverse events were similar between the two groups. The effects of finerenone on blood pressure were modest. No gynecomastia events were reported in the study. Hyperkalemia leading to discontinuation occurred in eight (4.3%) and two (1.1%) participants in the finerenone and control groups, respectively. The incidence of acute kidney injury was comparable between the two groups (1.6% vs. 1.6%). Conclusions: Finerenone resulted in lower risks of CKD progression than placebo and a balanced safety profile in Chinese patients with CKD and T2DM

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

A Voxel-based Morphometric Analysis of Cerebral Gray Matter in Subcortical Ischemic Vascular Dementia Patients and Normal Aged Controls

BACKGROUND AND PURPOSE: The present study was designed to detect the abnormalities of the cerebral grey-matter density in subcortical ischemic vascular dementia patients by FSL-VBM method to promote the early diagnosis of it.METHODS: Nine subcortical ischemic vascular dementia patients and nine age-matched normal controls underwent MRI brain structure scanning that was performed on a SIEMENS AVANTO 1.5 Tesla scanner and standard T1-weighted high-resolution anatomic scans of MPRAGE sequence were obtained. The 3-demensional MPRAGE images were processed with FSL-VBM package and the cerebral gray matter density was compared between the subcortical ischemic vascular dementia patients and normal controls.RESULTS: Compared with the normal control group, the cerebral gray matter density of subcortical ischemic vascular dementia patients was found significantly decreasing, including brain regions of thalamus, parietal lobe, frontal lobe and temporal lobe (P&#60;0.05).CONCLUSIONS: The cerebral gray matter density alterations have closed correlation with cognitive dysfunction in subcortical ischemic vascular dementia patient and can be detected by MRI. MRI has some potential value in the diagnosis of them.</p

Risk factors analyses for lateral lymph node metastases in papillary thyroid carcinomas: a retrospective study of 356 patients

ABSTRACT Objective The aim of this study was to investigate the incidence and risk factors for lateral lymph node metastasis (LLNM) in patients with papillary thyroid carcinoma (PTC). Subjects and methods 356 patients diagnosed with PTC who underwent total thyroidectomy and central lymph node dissection and lateral lymph node dissection between January 2005 and December 2011 were enrolled. The relation between LLNM and clinicopathological features such as gender, age, tumor size, tumor spread, psammoma bodies, tumor multifocality, extrathyroidal extension (ETE), unilateral or bilateral disease, tumor primary location and central lymph node metastases (CLNM) was analyzed. Results The rate of LLNM was 75.0%. In the univariate analysis, it was significantly associated with age, tumor size, tumor spread, extrathyroidal extension, primary tumor location and central lymph node metastasis (p 1.5 cm with p = 0.05 but was unrelated to the other factors. Conclusion Patients with PTC, with the primary tumor located in the upper part of the lobe and positive central compartment lymph node metastasis with a tumor size > 1.5 cm diameter are more likely to have LLNM. Therefore, more meticulous evaluations including the lateral lymph nodes should be performed before surgery

Tailoring the electrolyte and cathode properties for optimizing the performance of symmetrical solid oxide fuel cells fabricated by one-step co-sintering method

Symmetrical solid oxide fuel cells (S-SOFCs) are prepared via a facile one-step co-sintering method with highly reactive Sm0.2Ce0.8O1.9 (SDC) electrolyte and Sr2Fe1.5Mo0.5O6-δ (SFM) electrodes. The phase compositions and microstructures are studied by XRD, TEM, and FESEM techniques, and the electrolyte-supported single cells with gas-tight SDC electrolyte and porous SFM-SDC electrode are prepared after one-step co-sintering at 1100 °C or higher temperatures for 4 h. In particular, the AC impedance spectra reveal that the SDC electrolyte sintered at 1200 °C exhibits the highest oxide ionic conductivity of ~35 mS/cm at 700 °C, while the electrode polarization resistance achieves the lowest value of 0.32 Ω·cm2 at 700 °C in air for the sample co-sintered at 1100 °C. Accordingly, the output measurements are carried out on the single cells co-sintered at 1100 °C and 1200 °C. It is found that the single cell co-sintered at 1200 °C possesses the highest peak power density of 216 mW/cm2 at 700 °C, demonstrating the potential application of the one-step co-sintering method in low-cost manufacturing of S-SOFCs