Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
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DOI：
10.1056/nejmoa2206286
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发表时间：
2022-08-27
影响因子：
158.5
通讯作者：
Langkilde, A. M.
中科院分区：
文献类型：
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作者：
Solomon, S. D.;McMurray, J. J., V;Langkilde, A. M.
背景：钠-葡萄糖共转运蛋白2 （SGLT2）抑制剂可降低左心室射血分数小于或等于40%的慢性心力衰竭患者因心力衰竭住院和心血管死亡的风险。SGLT2抑制剂对左室射血分数较高的患者是否有效尚不确定。方法：我们随机分配6263例心力衰竭和左心室射血分数超过40%的患者，在常规治疗的基础上接受达格列净（剂量为10mg，每日一次）或相匹配的安慰剂。主要结局是恶化的心力衰竭（定义为因心力衰竭而意外住院或因心力衰竭而紧急就诊）或心血管死亡的综合结果，这是在事件时间分析中评估的。结果：在平均2.3年的时间里，达格列净组3131例患者中有512例（16.4%）出现主要结局，安慰剂组3132例患者中有610例（19.5%）出现主要结局（风险比为0.82；95%可信区间[CI]， 0.73 ~ 0.92; P < 0.001）。达格列净组368例（11.8%）患者心衰加重，安慰剂组455例（14.5%）患者心衰加重（风险比，0.79;95% CI, 0.69 ~ 0.91）；分别有231例（7.4%）和261例（8.3%）发生心血管死亡（风险比0.88;95% CI 0.74 ~ 1.05）。达格列净组的总事件和症状负担低于安慰剂组。左心室射血分数大于或等于60%的患者与左心室射血分数小于60%的患者的结果相似，在预先指定的亚组中，包括有或没有糖尿病的患者，结果相似。两组不良事件发生率相似。结论：达格列净降低了心力衰竭和射血分数轻度降低或保持的患者心力衰竭恶化或心血管死亡的综合风险。（由阿斯利康资助；DELIVER ClinicalTrials.gov号码，.）
BACKGROUND Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure and cardiovascular death among patients with chronic heart failure and a left ventricular ejection fraction of 40% or less. Whether SGLT2 inhibitors are effective in patients with a higher left ventricular ejection fraction remains less certain. METHODS We randomly assigned 6263 patients with heart failure and a left ventricular ejection fraction of more than 40% to receive dapagliflozin (at a dose of 10 mg once daily) or matching placebo, in addition to usual therapy. The primary outcome was a composite of worsening heart failure (which was defined as either an unplanned hospitalization for heart failure or an urgent visit for heart failure) or cardiovascular death, as assessed in a time-to-event analysis. RESULTS Over a median of 2.3 years, the primary outcome occurred in 512 of 3131 patients (16.4%) in the dapagliflozin group and in 610 of 3132 patients (19.5%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.92; P < 0.001). Worsening heart failure occurred in 368 patients (11.8%) in the dapagliflozin group and in 455 patients (14.5%) in the placebo group (hazard ratio, 0.79; 95% CI, 0.69 to 0.91); cardiovascular death occurred in 231 patients (7.4%) and 261 patients (8.3%), respectively (hazard ratio, 0.88; 95% CI, 0.74 to 1.05). Total events and symptom burden were lower in the dapagliflozin group than in the placebo group. Results were similar among patients with a left ventricular ejection fraction of 60% or more and those with a left ventricular ejection fraction of less than 60%, and results were similar in prespecified subgroups, including patients with or without diabetes. The incidence of adverse events was similar in the two groups. CONCLUSIONS Dapagliflozin reduced the combined risk of worsening heart failure or cardiovascular death among patients with heart failure and a mildly reduced or preserved ejection fraction. (Funded by AstraZeneca; DELIVER ClinicalTrials.gov number, .)