依帕列净治疗心力衰竭患者

来源：NEJM医学前沿

SGLT2抑制剂可降低2型糖尿病患者因心力衰竭住院和发生严重肾脏事件的风险。由于我们并未在其他抗糖尿病药中观察到类似效应，因此这些益处不能用SGLT2抑制剂降低血糖的作用来解释。短视频中总结了新的研究发现。                                         

心力衰竭患者接受依帕列净治疗的心血管和肾脏结局

Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure

摘 要

背景

钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂可降低患者因心力衰竭住院的风险，且不论患者是否有糖尿病，均有这一效果。我们需要更多证据证明这些药物对各种心力衰竭患者产生的效应，包括射血分数明显降低的患者。

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.

方法

在这项双盲试验中，我们将3730例射血分数≤40%的Ⅱ级、Ⅲ级或Ⅳ级心力衰竭患者随机分组，两组分别在推荐疗法的基础上加用依帕列净（empagliflozin）（每日10 mg）或安慰剂。主要结局是由心血管原因死亡或因心力衰竭加重住院构成的复合结局。

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.

结果

在中位16个月期间，依帕列净组1863例患者中的361例（19.4%）和安慰剂组1867例患者中的462例（24.7%）发生了主要结局事件（心血管原因死亡或因心力衰竭住院的风险比，0.75；95%置信区间[CI]，0.65~0.86；P<0.001）。无论是否患糖尿病，依帕列净对主要结局产生的效应均一致。依帕列净组中因心力衰竭住院的总人数少于安慰剂组（风险比，0.70；95% CI，0.58~0.85；P<0.001）。依帕列净组的估计肾小球滤过率的年下降速率比安慰剂组慢（每年–0.55vs. –2.28 mL/[min·1.73 m2]，P<0.001），并且接受依帕列净治疗的患者发生严重肾脏结局的风险较低。依帕列净组中单纯性生殖道感染的发生率较高。

Result

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.

结论

在针对心力衰竭接受推荐治疗的患者中，不论是否患糖尿病，依帕列净组的心血管原因死亡或因心力衰竭住院风险均低于安慰剂组。（由勃林格殷格翰公司和礼来公司资助；EMPEROR-Reduced在ClinicalTrials.gov注册号为NCT03057977。）

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. (Funded by Boehringer Ingelheim and Eli Lilly; EMPEROR-Reduced ClinicalTrials.gov number, NCT03057977.)

Milton Packer, Stefan D. Anker, Javed Butler, et al. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. DOI:10.1056/NEJMoa2022190

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