在射血分数降低的新发心力衰竭患者中启用依普利酮或螺内酯、治疗依从性和相关结局：一项全国性队列研究。

Initiation of eplerenone or spironolactone, treatment adherence, and associated outcomes in patients with new-onset heart failure with reduced ejection fraction: a nationwide cohort study.

机构信息

Department of Cardiology, Copenhagen University Hospital-Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark.

Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Bispebjerg Bakke 23, 2400 Copenhagen, Denmark.

出版信息

Eur Heart J Cardiovasc Pharmacother. 2023 Sep 20;9(6):546-552. doi: 10.1093/ehjcvp/pvad045.

DOI:10.1093/ehjcvp/pvad045

PMID:37355774

Abstract

BACKGROUND

The mineralocorticoid receptor antagonists (MRAs) eplerenone and spironolactone are beneficial in heart failure with reduced ejection fraction (HFrEF), but have not been prospectively compared. We compared clinical outcomes, daily dosages, and discontinuation rates for the two drugs in a nationwide cohort.

METHODS

We identified all patients with HFrEF in the period 2016-2020, who were alive and had initiated MRA treatment at study start, 180 days after HF diagnosis. We estimated the 2-year risk of a composite of death and HF hospitalization, as well as each component separately, using Kaplan-Meier, cumulative incidence functions, and Cox proportional hazards models adjusted for age, sex, and comorbidities. Secondly, we assessed treatment withdrawal, cross-over, and daily drug dosage.

RESULTS

We included 7479 patients; 653 (9%) on eplerenone and 6840 (91%) on spironolactone. Patients in the eplerenone group were younger (median age 65 vs. 69 years), and more often men (91% vs. 68%), both P < 0.001. In adjusted analyses, with spironolactone as reference, there were no differences in the risk of the composite of all-cause death and HF hospitalization (HR 1.02, 95% CI 0.82-1.27), all-cause death (HR 0.93, 95% CI 0.67-1.30), or HF hospitalization (HR 1.10, 95% CI 0.84-1.42). Treatment withdrawal occurred in 34% in the eplerenone group and 53% in the spironolactone group (P < 0.001), treatment cross-over in 3%, and 10%, respectively. Daily dose >25 mg at 12 months, was observed in 230 patients (37%) in the eplerenone group and 771 patients (12%) in the spironolactone (P < 0.001).

CONCLUSIONS

In a contemporary nationwide cohort of patients with new-onset HFrEF who initiated MRA, we found no differences in clinical outcomes associated with initiation of eplerenone vs. spironolactone. Treatment was more frequently withdrawn, and daily drug dosage was lower among patients treated with spironolactone.

摘要

背景

盐皮质激素受体拮抗剂（MRA）依普利酮和螺内酯对射血分数降低的心力衰竭（HFrEF）有益，但尚未进行前瞻性比较。我们在全国性队列中比较了这两种药物的临床结局、日剂量和停药率。

方法

我们在 2016 年至 2020 年期间确定了所有 HFrEF 患者，这些患者在研究开始时存活且在 HF 诊断后 180 天开始接受 MRA 治疗。我们使用 Kaplan-Meier、累积发生率函数和 Cox 比例风险模型来估计复合终点（死亡和 HF 住院的组合）以及每个组成部分的 2 年风险，这些模型经过年龄、性别和合并症的调整。其次，我们评估了治疗停药、交叉和每日药物剂量。

结果

我们纳入了 7479 名患者；653 名（9%）服用依普利酮，6840 名（91%）服用螺内酯。依普利酮组的患者年龄较小（中位年龄 65 岁 vs. 69 岁），且男性更多（91% vs. 68%），均 P<0.001。在调整后的分析中，以螺内酯为参照，全因死亡和 HF 住院的复合终点（HR 1.02，95%CI 0.82-1.27）、全因死亡（HR 0.93，95%CI 0.67-1.30）或 HF 住院（HR 1.10，95%CI 0.84-1.42）风险无差异。依普利酮组的治疗停药率为 34%，螺内酯组为 53%（P<0.001），治疗交叉分别为 3%和 10%。在 12 个月时，依普利酮组有 230 名（37%）患者和螺内酯组有 771 名（12%）患者的日剂量>25mg（P<0.001）。