Journal of the American College of Cardiology · 2024
Finerenone and Kidney Outcomes in Patients With Heart Failure: The FINEARTS-HF Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание 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.
Mc Causland Finnian R, Vaduganathan Muthiah, Claggett Brian L, Kulac Ian J, Desai Akshay S, Jhund Pardeep S, Henderson Alasdair D, Brinker Meike, Perkins Robert, Scheerer Markus F, Schloemer Patrick, Lam Carolyn S P, Senni Michele, Shah Sanjiv J, Voors Adriaan A, Zannad Faiez, Pitt Bertram, McMurray John J V, Solomon Scott D
Аннотация
BACKGROUND: Finerenone has kidney-protective effects in patients with chronic kidney disease with type 2 diabetes, but effects on kidney outcomes in patients with heart failure with and without diabetes and/or chronic kidney disease are not known.
OBJECTIVES: The purpose of this study was to examine the effects of finerenone on kidney outcomes in FINEARTS-HF (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients With Heart Failure), a randomized trial of finerenone vs placebo among patients with heart failure with mildly reduced or preserved ejection fraction.
METHODS: We explored the effects of finerenone on the secondary outcome of a sustained ≥50% estimated glomerular filtration rate (eGFR) decline or kidney failure (sustained eGFR decline <15 mL/min/1.73 m2; initiation of maintenance dialysis; renal transplantation). In this prespecified analysis, we also report effects of finerenone on: 1) sustained ≥57% eGFR decline or kidney failure; 2) eGFR slope; and 3) changes in urine albumin/creatinine ratio (UACR).
RESULTS: Among 6,001 participants, mean baseline eGFR was 62 ± 20 mL/min/1.73 m2; 48% had eGFR <60 mL/min/1.73 m2. Overall, 5,797 had baseline UACR data (median: 18 mg/g [Q1-Q3: 7-67 mg/g]). Over 2.6 years median follow-up, the incidence of the composite kidney outcome (≥50% eGFR decline or kidney failure) was numerically, but nonsignificantly, higher for finerenone vs placebo (75 vs 55 events; HR: 1.33; 95% CI: 0.94-1.89). Similar results were observed for the composite of ≥57% eGFR decline or kidney failure (41 vs 31 events; HR: 1.28; 95% CI: 0.80-2.05), although the overall event frequency was relatively low. During the first 3 months, finerenone led to an acute decline in eGFR of -2.9 mL/min/1.73 m2 (95% CI: -3.4 to -2.4 mL/min/1.73 m2) but did not alter chronic (from 3 months) eGFR slope (+0.2 mL/min/1.73 m2 per year; 95% CI: -0.1 to 0.4 mL/min/1.73 m2 per year), vs placebo. The difference in total slope was -0.7 mL/min/1.73 m2 per year (95% CI: -0.9 to -0.4 mL/min/1.73 m2 per year.). Finerenone reduced UACR by 30% (95% CI: 25%-34%) over 6 months vs placebo, an effect that persisted throughout follow-up. Finerenone reduced the risk of new-onset of microalbuminuria and macroalbuminuria by 24% (HR: 0.76; 95% CI: 0.68-0.83) and 38% (HR: 0.62; 95% CI: 0.53-0.73), respectively.
CONCLUSIONS: In FINEARTS-HF, a population at low risk of adverse kidney outcomes, finerenone did not significantly modify the kidney composite outcomes. Finerenone led to a greater reduction in initial eGFR, but did not result in a significant difference in chronic eGFR slope vs placebo. Finerenone led to early and sustained reductions in albuminuria and reduced the risk of new-onset micro- and macroalbuminuria. (FINEARTS-HF [Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenon on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants with Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%]; NCT04435626).
OBJECTIVES: The purpose of this study was to examine the effects of finerenone on kidney outcomes in FINEARTS-HF (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients With Heart Failure), a randomized trial of finerenone vs placebo among patients with heart failure with mildly reduced or preserved ejection fraction.
METHODS: We explored the effects of finerenone on the secondary outcome of a sustained ≥50% estimated glomerular filtration rate (eGFR) decline or kidney failure (sustained eGFR decline <15 mL/min/1.73 m2; initiation of maintenance dialysis; renal transplantation). In this prespecified analysis, we also report effects of finerenone on: 1) sustained ≥57% eGFR decline or kidney failure; 2) eGFR slope; and 3) changes in urine albumin/creatinine ratio (UACR).
RESULTS: Among 6,001 participants, mean baseline eGFR was 62 ± 20 mL/min/1.73 m2; 48% had eGFR <60 mL/min/1.73 m2. Overall, 5,797 had baseline UACR data (median: 18 mg/g [Q1-Q3: 7-67 mg/g]). Over 2.6 years median follow-up, the incidence of the composite kidney outcome (≥50% eGFR decline or kidney failure) was numerically, but nonsignificantly, higher for finerenone vs placebo (75 vs 55 events; HR: 1.33; 95% CI: 0.94-1.89). Similar results were observed for the composite of ≥57% eGFR decline or kidney failure (41 vs 31 events; HR: 1.28; 95% CI: 0.80-2.05), although the overall event frequency was relatively low. During the first 3 months, finerenone led to an acute decline in eGFR of -2.9 mL/min/1.73 m2 (95% CI: -3.4 to -2.4 mL/min/1.73 m2) but did not alter chronic (from 3 months) eGFR slope (+0.2 mL/min/1.73 m2 per year; 95% CI: -0.1 to 0.4 mL/min/1.73 m2 per year), vs placebo. The difference in total slope was -0.7 mL/min/1.73 m2 per year (95% CI: -0.9 to -0.4 mL/min/1.73 m2 per year.). Finerenone reduced UACR by 30% (95% CI: 25%-34%) over 6 months vs placebo, an effect that persisted throughout follow-up. Finerenone reduced the risk of new-onset of microalbuminuria and macroalbuminuria by 24% (HR: 0.76; 95% CI: 0.68-0.83) and 38% (HR: 0.62; 95% CI: 0.53-0.73), respectively.
CONCLUSIONS: In FINEARTS-HF, a population at low risk of adverse kidney outcomes, finerenone did not significantly modify the kidney composite outcomes. Finerenone led to a greater reduction in initial eGFR, but did not result in a significant difference in chronic eGFR slope vs placebo. Finerenone led to early and sustained reductions in albuminuria and reduced the risk of new-onset micro- and macroalbuminuria. (FINEARTS-HF [Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenon on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants with Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%]; NCT04435626).