Effects of the Non-Steroidal MRA Finerenone with and without Concomitant SGLT2 Inhibitor Use in Heart Failure

医学 危险系数 内科学 置信区间 射血分数 安慰剂 比例危险模型 心力衰竭 随机对照试验 人口 替代医学 环境卫生 病理
作者
Muthiah Vaduganathan,Brian Claggett,Ian J. Kulac,Zi Michael Miao,Akshay S. Desai,Pardeep S. Jhund,Alasdair Henderson,Meike Brinker,James Lay‐Flurrie,Prabhakar Viswanathan,Markus F. Scheerer,Andrea Lage,Carolyn S.P. Lam,Michele Senni,Sanjiv J. Shah,Adriaan A. Voors,Faı̈ez Zannad,Bertram Pitt,John J.V. McMurray,Scott D. Solomon
出处
期刊:Circulation [Lippincott Williams & Wilkins]
卷期号:151 (2): 149-158 被引量:9
标识
DOI:10.1161/circulationaha.124.072055
摘要

BACKGROUND: Patients with heart failure (HF) with mildly reduced or preserved ejection fraction face heightened long-term risks of morbidity and mortality. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) and the nonsteroidal mineralocorticoid receptor antagonist finerenone have both been shown to reduce the risk of cardiovascular events in this population, but the effects of their combined use are not known. METHODS: FINEARTS-HF (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients With Heart Failure) was a randomized, double-blind, placebo-controlled trial of finerenone in patients with HF and left ventricular ejection fraction ≥40%. Baseline SGLT2i use was a prespecified subgroup. The primary outcome was a composite of total (first and recurrent) worsening HF events and cardiovascular death. We first assessed for evidence of treatment heterogeneity on the basis of baseline SGLT2i use. We further examined SGLT2i uptake during the trial and evaluated the treatment effects of finerenone accounting for baseline and during-trial use of SGLT2i in time-varying analyses. RESULTS: Among 6001 participants, 817 (13.6%) were treated with an SGLT2i at baseline. During 2.6 years median follow-up, treatment with finerenone similarly reduced the risk of the primary outcome in participants treated with an SGLT2i (rate ratio, 0.83 [95% CI, 0.60–1.16]) and without an SGLT2i at baseline (rate ratio, 0.85 [95% CI, 0.74–0.98]; P interaction =0.76). In follow-up, 980 participants initiated SGLT2i, which was less frequent in the finerenone arm compared with placebo (17.7% versus 20.1%; hazard ratio, 0.86 [95% CI, 0.76–0.97]). Time-updated analyses accounting for baseline and subsequent use of SGLT2i did not meaningfully alter the treatment effects of finerenone on the primary end point. CONCLUSIONS: The treatment benefits of the nonsteroidal mineralocorticoid receptor antagonist finerenone were observed irrespective of concomitant use of an SGLT2i. These data suggest that the combined use of SGLT2i and a nonsteroidal mineralocorticoid receptor antagonist may provide additive protection against cardiovascular events in patients with HF with mildly reduced or preserved ejection fraction. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04435626.
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