Effect of Empagliflozin on Cardiovascular and Renal Outcomes in Patients With Heart Failure by Baseline Diabetes Status: Results From the EMPEROR-Reduced Trial.
Effect of Empagliflozin on Cardiovascular and Renal Outcomes in Patients With Heart Failure by Baseline Diabetes Status: Results From the EMPEROR-Reduced Trial.
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DOI：
10.1161/circulationaha.120.051824
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发表时间：
2021-01-26
期刊：
影响因子：
37.8
通讯作者：
Packer M
中科院分区：
文献类型：
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作者：
Anker SD;Butler J;Filippatos G;Khan MS;Marx N;Lam CSP;Schnaidt S;Ofstad AP;Brueckmann M;Jamal W;Bocchi EA;Ponikowski P;Perrone SV;Januzzi JL;Verma S;Böhm M;Ferreira JP;Pocock SJ;Zannad F;Packer M
补充数字内容可在文本中找到。钠-葡萄糖协同转运蛋白2抑制剂可改善射血分数降低的心力衰竭患者的预后，但还需要更多关于血糖状态是否影响其对心力衰竭和肾脏事件的获益程度的信息。II-IV级心力衰竭和左心室射血分数≤40%的患者在推荐治疗的基础上随机接受恩格列净（每日10 mg）或安慰剂。我们预先规定了恩格列净在糖尿病患者和非糖尿病患者中的作用比较。在入组的3730例患者中，1856例（50%）患有糖尿病，1268例（34%）患有前驱糖尿病（血红蛋白A1 c [HbA 1c] 5.7-6.4%），606例（16%）血糖正常（HbA 1c <5.7%）。糖尿病患者的主要结局（心血管死亡或因心力衰竭住院）、因心力衰竭住院总次数和不良肾脏结局的风险较高，但前驱糖尿病患者与血糖正常的患者相似。恩格列净降低了糖尿病患者和非糖尿病患者的主要结局风险（风险比分别为0.72 [95% CI，0.60-0.87]和0.78 [95% CI，0.64-0.97]，P-相互作用=0.57）。糖尿病患者和非糖尿病患者在恩格列净对心力衰竭住院总次数、估计肾小球滤过率随时间下降以及严重不良肾脏结局风险的影响方面也无差异。在这些终点中，药物的作用在糖尿病前期或血糖正常的患者中没有差异。作为连续变量分析时，基线HbA 1c未显著改变恩格列净对主要结局的获益（P-相互作用=0.40）。恩格列净未降低糖尿病前期或血糖正常患者的HbA 1c，且与低血糖风险增加无关。在EMPEROR-Reduced（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，恩格列净显著改善了射血分数降低的心力衰竭患者的心血管和肾脏结局，与基线糖尿病状态无关，并且跨越HbA 1c连续体。URL：https://www.clinicaltrials.gov;唯一标识符：NCT 03057977。
Supplemental Digital Content is available in the text. Sodium-glucose cotransporter 2 inhibitors improve outcomes in patients with heart failure with reduced ejection fraction, but additional information is needed about whether glycemic status influences the magnitude of their benefits on heart failure and renal events. Patients with Class II–IV heart failure and a left ventricular ejection fraction ≤40% were randomized to receive empagliflozin (10 mg daily) or placebo in addition to recommended therapy. We prespecified a comparison of the effect of empagliflozin in patients with and without diabetes. Of the 3730 patients enrolled, 1856 (50%) had diabetes, 1268 (34%) had prediabetes (hemoglobin A1c [HbA1c] 5.7–6.4%), and 606 (16%) had normoglycemia (HbA1c <5.7%). The risks of the primary outcome (cardiovascular death or hospitalization for heart failure), total hospitalizations for heart failure, and adverse renal outcomes were higher in patients with diabetes, but were similar between patients with prediabetes and normoglycemia. Empagliflozin reduced the risk of the primary outcome in patients with and without diabetes (hazard ratio, 0.72 [95% CI, 0.60–0.87] and 0.78 [95% CI, 0.64–0.97], respectively, P-interaction=0.57). Patients with and without diabetes also did not differ with respect to the effect of empagliflozin on total hospitalizations for heart failure, on the decline in estimated glomerular filtration rate over time, and on the risk of serious adverse renal outcomes. Among these end points, the effects of the drug did not differ in patients with prediabetes or normoglycemia. When analyzed as a continuous variable, baseline HbA1c did not significantly modify the benefits of empagliflozin on the primary outcome (P-interaction=0.40). Empagliflozin did not lower HbA1c in patients with prediabetes or normoglycemia and was not associated with increased risk of hypoglycemia. In EMPEROR-Reduced (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction), empagliflozin significantly improved cardiovascular and renal outcomes in patients with heart failure and a reduced ejection fraction, independent of baseline diabetes status and across the continuum of HbA1c. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03057977.