5 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
Sodium Intake as a Modulator of Kidney Function
Individual responses to alterations in salt intake vary widely. While salt has no effect on blood pressure in some people, it may substantially increase pressure in others. The reason why this difference exists is not very clear yet but many observations point towards the kidney as an important mediator. The adaptation in urinary output of sodium after a salt challenge (increase or decrease) also is not uniform. It is thought that the renin-angiotensin system may play an important role in determining how much sodium the body expels or retains after salt intake is suddenly reduced or augmented. Recent data suggest that the peptide Ang (1-7) and the endogenous nitric oxide inhibitor asymmetric dimethylarginine could be critically involved in the regulation of the renal response to altered salt intake
Impact of phosphate binders on quality of life in dialysis patients: Results from the prospective Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes study
Background: Phosphate binders cause high pill burden for dialysis patients, complicate medication regimens, and have unpleasant taste and large size which may affect patients' quality of life. This study explores the association between phosphate binder pill burden and health-related quality of life (HRQoL) in dialysis patients. Methods: We conducted a cross-sectional multi-centre cohort study in 21 Dutch dialysis centres. Phosphate binder pill burden was extracted from electronic patient records. Primary outcome was HRQoL measured with the Short Form 12 physical and mental component summary scores (PCS and MCS). Secondary endpoints were severity of gastro-intestinal symptoms, itching, dry mouth, and mental health symptoms, measured with the Dialysis Symptom Index. Results: Of 388 included patients, aged 62 ± 16 years, 77% underwent haemodialysis. PCS scores were comparable for patients with and without phosphate binders. Patients using 1–3 pills reported lower scores for decreased appetite (β −0.5; 95%CI −0.9 to −0.2), implying better appetite, than patients without phosphate binders. Patients using 4–6 pills also reported lower scores for decreased appetite (β −0.5; 95%CI −0.8 to −0.1) and for itching (β −0.5; 95%CI −0.9 to −0.1). Patients using >6 pills reported lower MCS (β −2.9; 95%CI −6.2–0.4) and higher scores for feeling nervous (β 0.6; 95%CI 0.1–1.1) and feeling sad (β 0.4; 95%CI 0.0–0.9). Conclusion: Phosphate binder pill burden is not associated with physical quality of life. A higher pill burden is associated with better appetite and less itching. Patients using >6 pills per day report lower mental quality of life and felt nervous and sad more often