Empagliflozin in heart failure with preserved ejection fraction: from randomized trials to real-world evidence.

IF 2.5 4区医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

Acta cardiologica Pub Date : 2025-09-01 Epub Date: 2025-08-08 DOI:10.1080/00015385.2025.2538386

Sebastiaan Dhont, Amrit Singh, Bram Swinnen, Kwinten Vandebergen, Vince Smolders, Evelyne Meekers, Wilfried Mullens, Pieter Martens, Philippe B Bertrand

{"title":"Empagliflozin in heart failure with preserved ejection fraction: from randomized trials to real-world evidence.","authors":"Sebastiaan Dhont, Amrit Singh, Bram Swinnen, Kwinten Vandebergen, Vince Smolders, Evelyne Meekers, Wilfried Mullens, Pieter Martens, Philippe B Bertrand","doi":"10.1080/00015385.2025.2538386","DOIUrl":null,"url":null,"abstract":"Background: The EMPEROR-Preserved clinical trial established empagliflozin as an effective therapy in heart failure with preserved ejection fraction (HFpEF), yet real-world validation in elderly, comorbid populations remain limited. We aimed to evaluate the clinical profile, tolerability, and outcomes of empagliflozin in a large Belgian HFpEF cohort.Methods: This retrospective, single-centre observational study of consecutive HFpEF patients (LVEF >50%) initiated on empagliflozin (10 mg daily) between April 2023 and April 2024. Baseline characteristics, clinical parameters, laboratory values, and outcomes were collected from electronic health records.Results: Of 798 screened patients, 577 were included (median age 82 years, 58% female). Atrial fibrillation (67%) and hypertension (78%) were highly prevalent. Empagliflozin use was associated with significant improvements in NYHA functional class (NYHA II: 56% to 77%, p < 0.001) and reduction in peripheral oedema (26% to 9%, p < 0.001). Modest reductions were observed in systolic blood pressure (131 to 130 mmHg, p = 0.017), heart rate (71 to 68 bpm, p = 0.004), body weight (76 to 75 kg, p < 0.001), and BMI (27.7 to 27.2 kg/m2, p < 0.001). Haemoglobin levels increased (p = 0.002), while renal function declined modestly without clinical sequelae. Treatment discontinuation occurred in 2.8% of patients, mainly due to genitourinary infections. During a median follow-up period of 16 months, the all-cause mortality rate was 6.9%.Conclusion: In real-world elderly and comorbid HFpEF population, empagliflozin was well tolerated and associated with improvements in congestion and functional status, supporting the external validity of randomised trial findings.","PeriodicalId":6979,"journal":{"name":"Acta cardiologica","volume":" ","pages":"730-735"},"PeriodicalIF":2.5000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Acta cardiologica","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/00015385.2025.2538386","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/8/8 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}

引用次数: 0

Abstract

Background: The EMPEROR-Preserved clinical trial established empagliflozin as an effective therapy in heart failure with preserved ejection fraction (HFpEF), yet real-world validation in elderly, comorbid populations remain limited. We aimed to evaluate the clinical profile, tolerability, and outcomes of empagliflozin in a large Belgian HFpEF cohort.

Methods: This retrospective, single-centre observational study of consecutive HFpEF patients (LVEF >50%) initiated on empagliflozin (10 mg daily) between April 2023 and April 2024. Baseline characteristics, clinical parameters, laboratory values, and outcomes were collected from electronic health records.

Results: Of 798 screened patients, 577 were included (median age 82 years, 58% female). Atrial fibrillation (67%) and hypertension (78%) were highly prevalent. Empagliflozin use was associated with significant improvements in NYHA functional class (NYHA II: 56% to 77%, p < 0.001) and reduction in peripheral oedema (26% to 9%, p < 0.001). Modest reductions were observed in systolic blood pressure (131 to 130 mmHg, p = 0.017), heart rate (71 to 68 bpm, p = 0.004), body weight (76 to 75 kg, p < 0.001), and BMI (27.7 to 27.2 kg/m², p < 0.001). Haemoglobin levels increased (p = 0.002), while renal function declined modestly without clinical sequelae. Treatment discontinuation occurred in 2.8% of patients, mainly due to genitourinary infections. During a median follow-up period of 16 months, the all-cause mortality rate was 6.9%.

Conclusion: In real-world elderly and comorbid HFpEF population, empagliflozin was well tolerated and associated with improvements in congestion and functional status, supporting the external validity of randomised trial findings.

查看原文本刊更多论文

恩帕列净对保留射血分数的心力衰竭的治疗：从随机试验到真实世界的证据。

背景：EMPEROR-Preserved临床试验证实恩格列净是一种有效的治疗具有保留射血分数（HFpEF）的心力衰竭的方法，但在老年合并症人群中的实际验证仍然有限。我们的目的是在一个大型比利时HFpEF队列中评估恩格列净的临床概况、耐受性和结局。方法：这项回顾性、单中心观察研究纳入了2023年4月至2024年4月期间连续接受恩格列净治疗的HFpEF患者（LVEF bbb50 %）（每日10mg）。从电子健康记录中收集基线特征、临床参数、实验室值和结果。结果：在798例筛查患者中，纳入577例（中位年龄82岁，58%为女性）。房颤（67%）和高血压（78%）非常普遍。使用依帕列净与NYHA功能等级（NYHA II: 56%至77%，p p = 0.017）、心率（71至68 bpm， p = 0.004）、体重（76至75 kg， p 2, p p = 0.002）的显著改善相关，而肾功能略有下降，无临床后遗症。2.8%的患者停止治疗，主要是由于泌尿生殖系统感染。在中位随访16个月期间，全因死亡率为6.9%。结论：在现实世界的老年人和合并症HFpEF人群中，恩格列净耐受性良好，并与充血和功能状态的改善相关，支持随机试验结果的外部有效性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Acta cardiologica 医学-心血管系统

CiteScore

2.50

自引率

12.50%

发文量

115

审稿时长

2 months

期刊介绍： Acta Cardiologica is an international journal. It publishes bi-monthly original, peer-reviewed articles on all aspects of cardiovascular disease including observational studies, clinical trials, experimental investigations with clear clinical relevance and tutorials.