Empagliflozin Improves Cardiovascular and Renal Outcomes in Heart Failure Irrespective of Systolic Blood Pressure,Journal of the American College of Cardiology

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Empagliflozin Improves Cardiovascular and Renal Outcomes in Heart Failure Irrespective of Systolic Blood Pressure
Journal of the American College of Cardiology ( IF 21.7 ) Pub Date : 2021-09-20 , DOI: 10.1016/j.jacc.2021.07.049
Michael Böhm ₁ , Stefan D Anker ₂ , Javed Butler ₃ , Gerasimos Filippatos ₄ , João Pedro Ferreira ₅ , Stuart J Pocock ₆ , Felix Mahfoud ₁ , Martina Brueckmann ₇ , Waheed Jamal ₈ , Anne Pernille Ofstad ₉ , Elke Schüler ₁₀ , Piotr Ponikowski ₁₁ , Christoph Wanner ₁₂ , Faiez Zannad ₅ , Milton Packer ₁₃ ,

Affiliation

Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Homburg/Saar, Germany.
Department of Cardiology (CVK), and Berlin Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner site Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany.
Department of Medicine, University of Mississippi School of Medicine, Jackson, Mississippi, USA.
National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens, Greece.
Université de Lorraine, Centre d'Investigation Clinique-Plurithématique Inserm CIC-P 1433, Nancy, France Inserm U1116, CHRU Nancy Brabois, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.
Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, United Kingdom.
Boehringer Ingelheim International, Ingelheim, Germany; Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.
Boehringer Ingelheim International, Ingelheim, Germany.
Medical Department, Boehringer Ingelheim Norway KS, Asker, Norway.
mainanalytics GmbH, Sulzbach/Taunus, Germany.
Wroclaw Medical University, Wrocław, Poland.
Medizinische Klinik und Poliklinik 1, Schwerpunkt Nephrologie, Universitätsklinikum Würzburg, Würzburg, Germany.
Baylor University Medical Center, Dallas, Texas, USA; Imperial College, London, United Kingdom.

Background

Empagliflozin reduces the risk of cardiovascular death or heart failure (HF) hospitalization in patients with reduced ejection fraction. Its interplay with systolic blood pressure (SBP) is not known.

Objectives

The goal of this study was to evaluate the interplay of SBP and the effects of empagliflozin in EMPEROR-Reduced (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction).

Methods

Study patients (N = 3,730) were randomly assigned to groups according to SBP at baseline (<110 mm Hg, n = 928; 110-130 mm Hg, n = 1,755; >130 mm Hg, n = 1,047). This study explored the influence of SBP on the effects of empagliflozin on cardiovascular death or HF hospitalization (primary outcome), as well as on total HF hospitalizations, rate of decline in estimated glomerular filtration rate, renal outcomes, and empagliflozin’s effects and significance on SBP.

Results

Over a median of 16 months considering only patients receiving placebo, baseline SBP and the risk of cardiovascular death or hospitalization for HF (P trend = 0.0015) were inversely related. Corrected for placebo, a slight early increase was observed in SBP at <110 mm Hg, no change at 110-130 mm Hg, and a slight reduction at >130 mm Hg. These between-group differences were of borderline significance (P for interaction trend = 0.05-0.10) after 4 and 12 weeks but were not significant later. SBP at baseline did not influence the effect of empagliflozin to reduce the risk of HF events or renal endpoints. When treated with empagliflozin, patients with SBP <110 mm Hg did not have an increased rate of symptomatic hypotension.

Conclusions

Empagliflozin was effective and safe, with no meaningful interaction between SBP and the effects of empagliflozin in the EMPEROR-Reduced trial. (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction [EMPEROR-Reduced]; NCT03057977)

中文翻译：

无论收缩压如何，恩格列净都能改善心力衰竭的心血管和肾脏结局

背景

Empagliflozin 可降低射血分数降低患者的心血管死亡或心力衰竭 (HF) 住院风险。它与收缩压 (SBP) 的相互作用尚不清楚。

目标

本研究的目的是评估 SBP 与 empagliflozin 在 EMPEROR-Reduced（射血分数降低的慢性心力衰竭患者的 Empagliflozin 结果试验）中的相互作用。

方法

研究患者 (N = 3,730) 根据基线时的 SBP 随机分组（<110 mm Hg，n = 928；110-130 mm Hg，n = 1,755；>130 mm Hg，n = 1,047）。本研究探讨了 SBP 对 empagliflozin 对心血管死亡或 HF 住院（主要结局）的影响，以及对总 HF 住院、估计肾小球滤过率下降率、肾脏结局的影响，以及 empagliflozin 对 SBP 的影响和意义.

结果

超过 16 个月的中位数，仅考虑接受安慰剂的患者，基线 SBP 和心血管死亡或因 HF 住院的风险（P趋势 = 0.0015）呈负相关。针对安慰剂进行校正后，在 <110 mmHg 时观察到 SBP 早期略有增加，在 110-130 mmHg 时没有变化，在 >130 mmHg 时略有下降。这些组间差异在 4 周和 12 周后具有临界显着性（交互趋势的P = 0.05-0.10），但在以后不显着。基线时的 SBP 不影响恩格列净降低 HF 事件或肾脏终点风险的效果。使用恩格列净治疗时，SBP <110 mmHg 的患者症状性低血压的发生率没有增加。