13 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
Particular Anatomy of the Hyperopic Eye and Potential Clinical Implications
Background and Objectives: Hyperopia is a refractive error which affects cognitive and social development if uncorrected and raises the risk of primary angle-closure glaucoma (PACG). Materials and Methods: The study included only the right eye—40 hyperopic eyes in the study group (spherical equivalent (SE) under pharmacological cycloplegia over 0.50 D), 34 emmetropic eyes in the control group (SE between −0.50 D and +0.50 D). A complete ophthalmological evaluation was performed, including autorefractometry to measure SE, and additionally we performed Ocular Response Analyser: Corneal Hysteresis (CH), Corneal Resistance Factor (CRF); specular microscopy: Endothelial cell density (CD), Cell variability (CV), Hexagonality (Hex), Aladdin biometry: Anterior Chamber Depth (ACD), Axial Length (AL), Central Corneal Thickness (CCT). IBM SPSS 26 was used for statistical analysis. Results: The mean age of the entire cohort was 22.93 years (SD ± 12.069), 66.22% being female and 33.78% male. The hyperopic eyes had significantly lower AL, ACD, higher SE, CH, CRF. In the hyperopia group, there are significant, negative correlations between CH and AL (r −0.335), CRF and AL (r −0.334), SE–AL (r −0.593), ACD and CV (r −0.528), CV and CRF (r −0.438), CH (r −0.379), and positive correlations between CCT and CH (r 0.393) or CRF (r 0.435), CD and ACD (r 0.509) or CH (0.384). Age is significantly, negatively correlated with ACD (r −0.447), CH (r −0.544), CRF (r −0.539), CD (r −0.546) and positively with CV (r 0.470). Conclusions: Our study suggests a particular biomechanical behavior of the cornea in hyperopia, in relation with morphological and endothelial parameters. Moreover, the negative correlation between age and ACD suggests a shallower anterior chamber as patients age, increasing the risk for PACG
Silicon Oxynitride Coatings Are Very Promising for Inert and Durable Pharmaceutical Glass Vials
Glass packaging of novel medicinal molecules is challenged
by hydrolysis
of the glass network from an interaction with the stored drug, likely
to result in leaching of constituent elements of the glass into the
solution. We have succeeded in applying chemical-vapor-deposited silicon
oxynitride coatings from a highly reactive trisilylamine derivative
molecule as a precursor, at a temperature below 580 °C, opening
up the possibility utilizing such coatings on glass surfaces. We demonstrate
that such silicon oxynitride coatings applied on the internal surface
of pharmaceutical vials prevent degradation, providing chemical inertness
and withstanding severe screening conditions of the United States
Pharmacopeia USP chapter. Fine structural determination
and atomistic modeling of the Si–O–N network of the
films confirm the nitrogen substitution of oxygen and densification
of the silicate network through the addition of the former. The achieved
barrier properties and excellent performance of these coatings pave
the way toward sustainable packaging with improved product shelf life,
transferable to multiple applications of surface coatings
The Mediterranean region under climate change
This book has been published by Allenvi (French National Alliance for Environmental Research) to coincide with the 22nd Conference of Parties to the United Nations Framework Convention on Climate Change (COP22) in Marrakesh. It is the outcome of work by academic researchers on both sides of the Mediterranean and provides a remarkable scientific review of the mechanisms of climate change and its impacts on the environment, the economy, health and Mediterranean societies. It will also be valuable in developing responses that draw on “scientific evidence” to address the issues of adaptation, resource conservation, solutions and risk prevention. Reflecting the full complexity of the Mediterranean environment, the book is a major scientific contribution to the climate issue, where various scientific considerations converge to break down the boundaries between disciplines