Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
Simultaneous initiation of finerenone and empagliflozin across the spectrum of kidney risk in the CONFIDENCE trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Vaduganathan Muthiah, Green Jennifer B, Heerspink Hiddo J L, Kim Sung Gyun, Mann Johannes F E, McGill Janet B, Mottl Amy, Nangaku Masaomi, Rosenstock Julio, Rossing Peter, Li Li, Li Na, Rohwedder Katja, Scott Charlie, Agarwal Rajiv
Аннотация
BACKGROUND: 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.
METHODS: The double-blind, double-dummy trial randomized 818 adults with CKD and type 2 diabetes [urine albumin-creatinine ratio (UACR) ≥100 to <5000 mg/g] to receive once-daily finerenone plus empagliflozin, finerenone alone or empagliflozin alone, all in addition to a renin-angiotensin system inhibitor. The relative change in UACR from baseline to day 180 (primary endpoint) and a >30% reduction in UACR (secondary endpoint) across KDIGO risk categories was assessed.
RESULTS: 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.
CONCLUSIONS: 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.
CLINICAL TRIAL REGISTRATION: NCT05254002; EudraCT 2021-003037-11.
METHODS: The double-blind, double-dummy trial randomized 818 adults with CKD and type 2 diabetes [urine albumin-creatinine ratio (UACR) ≥100 to <5000 mg/g] to receive once-daily finerenone plus empagliflozin, finerenone alone or empagliflozin alone, all in addition to a renin-angiotensin system inhibitor. The relative change in UACR from baseline to day 180 (primary endpoint) and a >30% reduction in UACR (secondary endpoint) across KDIGO risk categories was assessed.
RESULTS: 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.
CONCLUSIONS: 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.
CLINICAL TRIAL REGISTRATION: NCT05254002; EudraCT 2021-003037-11.
Предметные рубрики MeSH
HumansBenzhydryl CompoundsMaleFemaleGlucosidesMiddle AgedDouble-Blind MethodDiabetes Mellitus, Type 2Renal Insufficiency, ChronicAgedDrug Therapy, CombinationGlomerular Filtration RateNaphthyridinesFollow-Up StudiesPrognosisSodium-Glucose Transporter 2 InhibitorsAlbuminuriaDisease ProgressionRisk Factors