Butt Jawad H, Jhund Pardeep S, Henderson Alasdair D, Claggett Brian L, Desai Akshay S, Lam Carolyn S P, Brinker Meike, Schloemer Patrick, Viswanathan Prabhakar, Lage Andrea, Rohwedder Katja, Senni Michele, Shah Sanjiv J, Voors Adriaan A, Zannad Faiez, Pitt Bertram, Vaduganathan Muthiah, Solomon Scott D, McMurray John J V
British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.
Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Eur J Heart Fail. 2025 Apr 10. doi: 10.1002/ejhf.3649.
The efficacy and safety of the non-steroidal mineralocorticoid receptor antagonist, finerenone, have not been examined in patients without diabetes. We examined the efficacy and safety of finerenone, compared with placebo, according to glycaemic status in FINEARTS-HF.
A total of 6001 patients with heart failure (HF) with New York Heart Association functional class II-IV, left ventricular ejection fraction ≥40%, evidence of structural heart disease, and elevated N-terminal pro-B-type natriuretic peptide levels were randomized to finerenone or placebo. The effect of finerenone according to glycaemic status (i.e. normoglycaemia [no investigator-reported history of diabetes and glycated haemoglobin (HbA1c) <5.7%], pre-diabetes [no investigator-reported history of diabetes and HbA1c 5.7-6.4%] and diabetes [investigator-reported history of diabetes or HbA1c ≥6.5%]) at baseline were examined. The primary outcome was cardiovascular death and total worsening HF events. At baseline, 1243 (20.8%) patients were normoglycaemic, 1979 (33.1%) had pre-diabetes, and 2764 (46.2%) had diabetes. Compared with patients with normoglycaemia, those with diabetes, but not pre-diabetes, had a higher rate of the primary endpoint (normoglycaemia: reference; pre-diabetes: adjusted rate ratio [RR] 1.02, 95% confidence interval [CI] 0.84-1.23; diabetes: adjusted RR 1.32 [95% CI 1.11-1.58]). The benefit of finerenone on the primary outcome was consistent across glycaemic status (normoglycaemia: RR 0.85 [95% CI 0.63-1.14]; pre-diabetes: RR 0.85 [95% CI 0.66-1.08]; diabetes: RR 0.82 [95% CI 0.69-0.98]; p = 0.93). The effects of finerenone on the components of the primary outcome, all-cause death, composite kidney endpoints, and improvement in the Kansas City Cardiomyopathy Questionnaire total symptom score were not modified by glycaemic status.
In patients with HF with mildly reduced/preserved ejection fraction, the beneficial effects of finerenone, compared with placebo, on clinical events and symptoms, were consistent, irrespective of glycaemic status at baseline.
非甾体类盐皮质激素受体拮抗剂非奈利酮在无糖尿病患者中的疗效和安全性尚未得到研究。我们在FINEARTS-HF研究中，根据血糖状态比较了非奈利酮与安慰剂的疗效和安全性。
共有6001例纽约心脏病协会心功能II-IV级、左心室射血分数≥40%、有结构性心脏病证据且N末端B型利钠肽前体水平升高的心力衰竭（HF）患者被随机分为非奈利酮组或安慰剂组。研究了基线时非奈利酮根据血糖状态（即血糖正常[无研究者报告的糖尿病病史且糖化血红蛋白（HbA1c）<5.7%]、糖尿病前期[无研究者报告的糖尿病病史且HbA1c为5.7-6.4%]和糖尿病[研究者报告的糖尿病病史或HbA1c≥6.5%]）的效果。主要结局是心血管死亡和总的HF恶化事件。基线时，1243例（20.8%）患者血糖正常，1979例（33.1%）有糖尿病前期，2764例（46.2%）有糖尿病。与血糖正常的患者相比，糖尿病患者（而非糖尿病前期患者）的主要终点发生率更高（血糖正常：参照；糖尿病前期：调整后的率比[RR]1.02，95%置信区间[CI]0.84-1.23；糖尿病：调整后的RR 1.32[95%CI 1.11-1.58]）。非奈利酮对主要结局的益处在各血糖状态下是一致的（血糖正常：RR 0.85[95%CI 0.63-1.14]；糖尿病前期：RR 0.85[95%CI 0.66-1.08]；糖尿病：RR 0.82[95%CI 0.69-0.98]；p=0.93）。非奈利酮对主要结局的组成部分、全因死亡、复合肾脏终点以及堪萨斯城心肌病问卷总症状评分改善的影响未因血糖状态而改变。
在射血分数轻度降低/保留的HF患者中，与安慰剂相比，非奈利酮对临床事件和症状的有益作用是一致的，与基线时的血糖状态无关。
