| 1. |
- Ruilope, LM, et al.
(författare)
-
Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial
- 2019
-
Ingår i: American journal of nephrology. - : S. Karger AG. - 1421-9670 .- 0250-8095. ; 50:5, s. 345-356
-
Tidskriftsartikel (refereegranskat)abstract
- <b><i>Background:</i></b> 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. <b><i>Patients and</i></b> <b><i>Methods:</i></b> 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<sup>2</sup> 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 α = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. <b><i>Conclusions:</i></b> 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.
|
|
| 3. |
- Courtney Mustaphi, Colin J., et al.
(författare)
-
Guidelines for reporting and archiving Pb-210 sediment chronologies to improve fidelity and extend data lifecycle
- 2019
-
Ingår i: Quaternary Geochronology. - : Elsevier. - 1871-1014 .- 1878-0350. ; 52, s. 77-87
-
Tidskriftsartikel (refereegranskat)abstract
- Radiometric dating methods are essential for developing geochronologies to study Late Quaternary environmental change and 210Pb dating is commonly used to produce age-depth models from recent (within 150 years) sediments and other geoarchives. The past two centuries are marked by rapid environmental socio-ecological changes frequently attributed to anthropogenic land-use activities, modified biogeochemical cycles, and climate change. Consequently, historical reconstructions over this recent time interval have high societal value because analyses of these datasets provide understanding of the consequences of environmental modifications, critical ecosystem thresholds, and to define desirable ranges of variation for management, restoration, and conservation. For this information to be used more broadly, for example to support land management decisions or to contribute data to regional analyses of ecosystem change, authors must report all of the useful age-depth model information. However, at present there are no guidelines for researchers on what information should be reported to ensure Pb-210 data are fully disclosed, reproducible, and reusable; leading to a plethora of reporting styles, including inadequate reporting that reduces potential reusability and shortening the data lifecycle. For example, 64% of the publications in a literature review of Pb-210 dated geoarchives did not include any presentation of age uncertainty estimates in modeled calendar ages used in age-depth models. Insufficient reporting of methods and results used in Pb-210 dating geoarchives severely hampers reproducibility and data reusability, especially in analyses that make use of databased palaeoenvironmental data. Reproducibility of data is fundamental to further analyses of the number of palaeoenvironmental data and the spatial coverage of published geoarchives sites. We suggest, and justify, a set of minimum reporting guidelines for metadata and data reporting for Pb-210 dates, including an IEDA (Interdisciplinary Earth Data Alliance), LiPD (Linked Paleo Data) and generic format data presentation templates, to contribute to improvements in data archiving standards and to facilitate the data requirements of researchers analyzing datasets of several palaeoenvironmental study sites. We analyse practices of methods, results and first order interpretation of Pb-210 data and make recommendations to authors on effective data reporting and archiving to maximize the value of datasets. We provide empirical evidence from publications and practitioners to support our suggested reporting guidelines. These guidelines increase the scientific value of Pb-210 by expanding its relevance in the data lifecycle. Improving quality and fidelity of environmental datasets broadens interdisciplinary use, lengthens the potential lifecycle of data products, and achieves requirements applicable for evidenced-based policy support.
|
|
