Simultaneous initiation of finerenone and empagliflozin across the spectrum of kidney risk in the CONFIDENCE trial
EndocrinologiaResumo original em inglês
O que aconteceu
The CONFIDENCE (COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with CKD and type 2 diabetes using a UACR Endpoint) trial investigated the safety and efficacy of simultaneously initiating finerenone and empagliflozin for patients with chronic kidney disease (CKD) and type 2 diabetes. This prespecified analysis aimed to determine if the predicted risk of kidney disease progression, based on KDIGO risk categories, influenced the benefits and safety of this combination therapy.
The double-blind, double-dummy trial randomized 818 adults with CKD and type 2 diabetes [urine albumin-creatinine ratio (UACR) ≥100 to 30% reduction in UACR (secondary endpoint) across KDIGO risk categories was assessed.
NCT05254002; EudraCT 2021-003037-11.
O que encontraram
At baseline, among 781 with available data, 11.3% of participants were classified as low/moderate risk, 29.6% as high risk and 59.2% as very high risk. At 180 days, combination therapy significantly reduced UACR levels across all KDIGO risk categories (low/moderate: -61.7%; high: -60.7%; very high: -52.4%). This reduction was consistently greater than that achieved with either monotherapy alone. More than half of patients on combination therapy experienced UACR reductions of >30% (low/moderate: 58.1%; high: 74.2%; very high: 70.6%), again outperforming monotherapies across all risk groups. While hyperkalemia was more common with combination therapy, early eGFR declines (>30% within 30 days) were less frequent in individuals with higher KDIGO risk compared with lower risk. Overall, the safety profile of combination therapy remained consistent across all KDIGO risk categories, with no unexpected safety signals.
Por que isso importa
The CONFIDENCE trial demonstrates that the relative efficacy and safety of simultaneous finerenone and empagliflozin combination therapy are consistent across a wide spectrum of predicted kidney disease risk.
Resumo publicado sob licença CC BY. A tradução para o português ainda não chegou a este estudo.
O estudo original
Simultaneous initiation of finerenone and empagliflozin across the spectrum of kidney risk in the CONFIDENCE trial
Muthiah Vaduganathan, Jennifer B Green, Hiddo J.L. Heerspink, Sung Gyun Kim, Johannes F E Mann, Janet B McGill, Amy Mottl, Masaomi Nangaku, Julio Rosenstock, Peter R Rossing et al.
Descritores MeSH
- Naphthyridines
- Diabetes Mellitus, Type 2
- Benzhydryl Compounds
- Glucosides
- Renal Insufficiency, Chronic
- Female
- Follow-Up Studies
- Sodium-Glucose Transporter 2 Inhibitors
- Humans
- Male
Veja também
Estudos relacionados
- COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint (CONFIDENCE) trial: baseline clinical characteristics
- Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes
- Risk of Hyperkalemia With Empagliflozin, Finerenone, or Both: Secondary Analysis of the CONFIDENCE Randomized Trial
- Baseline Kidney Function, Albuminuria, and Urine Albumin-Creatinine Ratio Reduction with Finerenone, Empagliflozin, or Both: Post Hoc Analyses of CONFIDENCE Trial