POS-829 Incidence and predictors of hyperkalaemia in patients with CKD and T2D in the FIDELIO-DKD trial

Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) have an increased risk of hyperkalaemia. Finerenone, a novel, selective, nonsteroidal, mineralocorticoid receptor antagonist, reduced the incidence cardiovascular events in patients CKD T2D FIDELIO-DKD trial. This post hoc analysis describes predictors hyperkalaemia FIDELIO-DKD. was phase III, multicentre, double-blind trial that randomised 5734 (1:1) to finerenone or placebo. CKD, serum potassium ([K+]) ≤4.8 mmol/l at run-in screening visits, treated optimised renin–angiotensin system blockade were included. defined as urine albumin-to-creatinine ratio (UACR) ≥30–<5000 mg/g estimated glomerular filtration rate (eGFR) ≥25–<75 ml/min/1.73 m2. Initial dosing study drug (10 mg 20 once daily [od]) based on eGFR screening. During trial, [K+] levels changes, which monitored every visit; temporarily withheld if >5.5 restarted 10 od when ≤5.0 mmol/l. In this safety analysis, investigator-reported adverse event (AE) by (>5.5 >6.0 mmol/l); considered treatment-emergent they occurred after start administration until 3 days any interruption drug. Multivariate Cox proportional hazards regression used examine associations between baseline characteristics first post-baseline mmol/l, adjusting for treatment assignment covariates chosen priori clinical factors known affect [K+]. A p‑value <0.05 determine significant association. At baseline, 769/5658 (13.6%) 390/5658 (6.9%) had >4.8 >5.0 respectively. After median follow-up 2.6 years, 44/2827 (1.6%) group 12/2831 (0.4%) placebo experienced hyperkalaemia-related serious AE. group, 64/2827 (2.3%) permanently discontinued due hyperkalaemia, compared 25/2831 (0.9%) group. total, 597/2785 (21.4%) 256/2775 (9.2%) groups, respectively, while 126/2802 (4.5%) 38/2796 (1.4%) patients, Selected vs without during are shown Table. The results multivariate will be presented. K+ management protocol implemented minimised impact demonstrated low frequency clinically meaningful AEs. (Funded Bayer AG; clinicaltrials.gov number NCT02540993)