15 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
Effect of patient-specific model scaling on hip joint reaction force in one-legged stance – study of 356 hips
Estimation of hip joint loading is fundamental for understanding joint function, injury and disease. To predict patientspecific hip loading, a musculoskeletal model must be adapted to the patient’s unique geometry. By far the most common and cost effective clinical images are whole pelvis plain radiographs. This study compared the accuracy of anisotropic and isotropic scaling of musculoskeletal model to hip joint force prediction by taking patient-specific bone geometry from standard anteroposterior radiograms. Methods: 356 hips from 250 radiograms of adult human pelvis were analyzed. A musculoskeletal model was constructed from sequential images of the Visible Human Male. The common body position of one-legged stance was substituted for the midstance phase of walking. Three scaling methods were applied: a) anisotropic scaling by interhip separation, ilium height, ilium width, and lateral and inferior position of the greater trochanter, b) isotropic scaling by pelvic width and c) isotropic scaling by interhip separation. Hip joint force in one-legged stance was estimated by inverse static model. Results: Isotropic scaling affects all proportions equally, what results in small difference in hip joint reaction force among patients. Anisotropic hip scaling increases variation in hip joint force among patients considerably. The difference in hip joint force estimated by isotropic and anisotropic scaling may surpass patient’s body weight. Conclusions: Hip joint force estimated by isotropic scaling depends mostly on reference musculoskeletal geometry. Individual’s hip joint reaction force estimation could be improved by including additional bone geometrical parameters in the scaling method