美国贝勒心脏和血管研究所Milton Packer团队研究了依帕列净治疗心衰患者对心血管和肾功能预后的影响。2020年8月29日，该研究发表在《新英格兰医学杂志》上。

钠-葡萄糖共转运蛋白2（SGLT2）抑制剂可降低患者因心力衰竭而住院的风险，无论其是否存在糖尿病。但该药用于治疗包括射血分数明显降低的广泛心力衰竭患者，疗效尚不明确。

在这项双盲试验中，研究组招募了3730名II、III或IV级心力衰竭且射血分数不超过40％的患者，将其按1：1随机分配，除了推荐的治疗方法外，1863名接受依帕列净治疗，1867名接受安慰剂治疗。主要结局是心血管死亡或因心力衰竭加重而住院治疗的综合结果。

中位随访16个月后，依帕列净组有361名患者（19.4%）发生主要结局，显著低于安慰剂组（462名，24.7%）。无论患者是否存在糖尿病，依帕列净对主要结局的影响是一致的。依帕列净组因心衰而住院的总患者数显著低于安慰剂组。

依帕列净组中估计肾小球滤过率的年下降速率显著慢于安慰剂组，发生严重肾结局的风险亦显著低于安慰剂组。依帕列净组中单纯生殖道感染的风险显著高于安慰剂组。

总之，在接受推荐治疗的心衰患者中使用依帕列净可显著改善预后，无论是否存在糖尿病。

附：英文原文

Title: Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure | NEJM

Author: Milton Packer, M.D.,, Stefan D. Anker, M.D., Ph.D.,, Javed Butler, M.D.,, Gerasimos Filippatos, M.D.,, Stuart J. Pocock, Ph.D.,, Peter Carson, M.D.,, James Januzzi, M.D.,, Subodh Verma, M.D., Ph.D.,, Hiroyuki Tsutsui, M.D.,, Martina Brueckmann, M.D.,, Waheed Jamal, M.D.,, Karen Kimura, Ph.D.,, Janet Schnee, M.D.,, Cordula Zeller, Dipl.Math.,, Daniel Cotton, M.S.,, Edimar Bocchi, M.D.,, Michael Bhm, M.D., Ph.D.,, Dong-Ju Choi, M.D.,, Vijay Chopra, M.D.,, Eduardo Chuquiure, M.D.,, Nadia Giannetti, M.D.,, Stefan Janssens, M.D., Ph.D.,, Jian Zhang, M.D., Ph.D.,, Jose R. Gonzalez Juanatey, M.D.,, Sanjay Kaul, M.D.,, Hans-Peter Brunner-La Rocca, M.D.,, Bela Merkely, M.D.,, Stephen J. Nicholls, M.D.,, Sergio Perrone, M.D.,, Ileana Pina, M.D.,, Piotr Ponikowski, M.D.,, Naveed Sattar, M.D.,, Michele Senni, M.D.,, Marie-France Seronde, M.D.,, Jindrich Spinar, M.D.,, Iain Squire, M.D.,, Stefano Taddei, M.D.,, Christoph Wanner, M.D.,, and Faiez Zannad, M.D., Ph.D.

Issue&Volume: 2020-08-29

Abstract: 

Background

Sodium–glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure in patients regardless of the presence or absence of diabetes. More evidence is needed regarding the effects of these drugs in patients across the broad spectrum of heart failure, including those with a markedly reduced ejection fraction.

Methods

In this double-blind trial, we randomly assigned 3730 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive empagliflozin (10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of cardiovascular death or hospitalization for worsening heart failure.

Results

During a median of 16 months, a primary outcome event occurred in 361 of 1863 patients (19.4%) in the empagliflozin group and in 462 of 1867 patients (24.7%) in the placebo group (hazard ratio for cardiovascular death or hospitalization for heart failure, 0.75; 95% confidence interval [CI], 0.65 to 0.86; P<0.001). The effect of empagliflozin on the primary outcome was consistent in patients regardless of the presence or absence of diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001). The annual rate of decline in the estimated glomerular filtration rate was slower in the empagliflozin group than in the placebo group (–0.55 vs. –2.28 ml per minute per 1.73 m2 of body-surface area per year, P<0.001), and empagliflozin-treated patients had a lower risk of serious renal outcomes. Uncomplicated genital tract infection was reported more frequently with empagliflozin.

Conclusions

Among patients receiving recommended therapy for heart failure, those in the empagliflozin group had a lower risk of cardiovascular death or hospitalization for heart failure than those in the placebo group, regardless of the presence or absence of diabetes.

DOI: 10.1056/NEJMoa2022190

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2022190