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

OUR EXPERIENCE OF MONITORING OF DRUGS SAFETY IN GERONTOLOGICAL PRACTICE

The analysis of work on identification and registration of complications of medicinal therapy in medical institutions of the Irkutsk region showed that the frequency of undesirable medicinal reactions at inpatients is more senior than 60 years makes from 10 % to 25 %.&#x0D; At advanced age the special place is taken by dysfunction of a digestive tract and allergic reactions at purpose of cardiovascular medicines, and also antibacterial and the antiglaucomous medicines. The number of cases of absence of therapeutic effect of PM in this age group made 18,9 %, reactions from the digestive tract � 15,5 % of cases, thus in 6,5 % pseudomembranous colitis was registered. It is established that risk factors of emergency of such reaction were the background pain or depressive syndrome, accompanying application of more than three drugs and absence of the scheme of a titration of dosages.</jats:p