Incident hyperkalaemia risk model in chronic kidney disease and diabetes: the FIDELITY programme
Year: 2025
Type: article
Abstract: BACKGROUND AND AIMS: No tools are available for identifying patients with chronic kidney disease and Type 2 diabetes at high risk of hyperkalaemia. Using the FIDELITY pooled patient data set, a risk model for incident hyperkalaemia was developed and validated. METHODS: The primary outcome was new-onset hyperkalaemia (serum potassium >5.5 mmol/L). Data from the placebo arm were used for derivation and from the finerenone arm for validation. An integer risk score was built and divided into low-, intermediate-, and high-risk hyperkalaemia categories. Assessed efficacy outcomes included cardiovascular and kidney composites. RESULTS: Seven baseline covariates (serum potassium >4.5 mmol/L, prior history of hyperkalaemia, no sodium-glucose co-transporter-2 inhibitor use, urine albumin-to-creatinine ratio >1000 mg/g, haemoglobin <12 g/dL, no thiazide-type diuretic use, and estimated glomerular filtration rate <45 mL/min/1.73 m2) were independently associated with new-onset hyperkalaemia and used for building the integer risk model. The risk scores for derivation and validation were accurate and well calibrated. The derived integer score ranged from 0 to 12 points. The risk of new-onset hyperkalaemia increased across hyperkalaemia risk categories with 2.7, 7.0, and 16.7% of patients reporting a hyperkalaemia event in the low-risk (0-3 points), intermediate-risk (4-6 points), and high-risk (7-12 points) groups with placebo, respectively. Irrespective of hyperkalaemia risk, finerenone reduced cardiovascular and kidney events vs placebo. CONCLUSIONS: This integer risk score for new-onset hyperkalaemia in patients with chronic kidney disease and Type 2 diabetes could facilitate tailored treatment strategies and mitigate hyperkalaemia in high-risk patients.
Source: European Heart Journal
Institutions: Inserm, Universidade do Porto, Centre Hospitalier Régional et Universitaire de Nancy, Défaillance Cardiovasculaire Aiguë et Chronique, Unidade Local de Saúde Gaia/Espinho, Université de Lorraine, Deutsches Herzzentrum der Charité, German Centre for Cardiovascular Research, Charité - Universitätsmedizin Berlin, The University of Texas Southwestern Medical Center, University of Michigan, Michigan Medicine, University of Copenhagen, Steno Diabetes Center Copenhagen, Hospital Universitario 12 De Octubre, Centro de Investigación Biomédica en Red, Universidad Europea de Madrid, University of Würzburg, Universitätsklinikum Würzburg, Bayer (Germany), National and Kapodistrian University of Athens
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,922
Funder: Bayer
OpenAlex ID: W4409652489