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.
J Am Coll Cardiol. 2021 Sep 28;78(13):1337-1348. doi: 10.1016/j.jacc.2021.07.049.
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.
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).
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.
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.
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).
恩格列净可降低射血分数降低的心力衰竭（HF）患者的心血管死亡或 HF 住院风险。但其与收缩压（SBP）的相互作用尚不清楚。
本研究旨在评估 SBP 的相互作用以及 EMPEROR-Reduced 试验（恩格列净在射血分数降低的慢性心力衰竭患者中的结局试验）中恩格列净的作用。
研究患者（n=3730）根据基线时的 SBP 分为三组（<110mmHg，n=928；110-130mmHg，n=1755；>130mmHg，n=1047）。本研究探讨了 SBP 对恩格列净对心血管死亡或 HF 住院（主要终点）以及总 HF 住院、估计肾小球滤过率下降率、肾脏结局以及恩格列净对 SBP 的作用和意义的影响。
仅考虑接受安慰剂的患者，中位随访 16 个月后，基线 SBP 与心血管死亡或 HF 住院风险呈负相关（P 趋势=0.0015）。校正安慰剂后，<110mmHg 组 SBP 早期略有升高，110-130mmHg 组 SBP 无变化，>130mmHg 组 SBP 略有降低。这些组间差异在 4 周和 12 周时有边缘统计学意义（P 趋势=0.05-0.10），但随后无统计学意义。基线 SBP 不影响恩格列净降低 HF 事件或肾脏终点风险的作用。接受恩格列净治疗时，SBP<110mmHg 的患者没有出现症状性低血压的发生率增加。
恩格列净有效且安全，在 EMPEROR-Reduced 试验中，SBP 与恩格列净的作用之间没有有意义的相互作用。（恩格列净在射血分数降低的慢性心力衰竭患者中的结局试验[EMPEROR-Reduced]；NCT03057977）。
