National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Greece (G.F.).
Baylor Scott and White Research Institute, Dallas, TX (J.B.).
Circulation. 2022 Aug 30;146(9):676-686. doi: 10.1161/CIRCULATIONAHA.122.059785. Epub 2022 Jun 28.
Empagliflozin improves outcomes in patients with heart failure with a preserved ejection fraction, but whether the effects are consistent in patients with and without diabetes remains to be elucidated.
Patients with class II through IV heart failure and a left ventricular ejection fraction >40% were randomized to receive empagliflozin 10 mg or placebo in addition to usual therapy. We undertook a prespecified analysis comparing the effects of empagliflozin versus placebo in patients with and without diabetes.
Of the 5988 patients enrolled, 2938 (49%) had diabetes. The risk of the primary outcome (first hospitalization for heart failure or cardiovascular death), total hospitalizations for heart failure, and estimated glomerular filtration rate decline was higher in patients with diabetes. Empagliflozin reduced the rate of the primary outcome irrespective of diabetes status (hazard ratio, 0.79 [95% CI, 0.67, 0.94] for patients with diabetes versus hazard ratio, 0.78 [95% CI, 0.64, 0.95] in patients without diabetes; =0.92). The effect of empagliflozin to reduce total hospitalizations for heart failure was also consistent in patients with and without diabetes. The effect of empagliflozin to attenuate estimated glomerular filtration rate decline during double-blind treatment was also present in patients with and without diabetes, although more pronounced in patients with diabetes (1.77 in diabetes versus 0.98 mL/min/1.73m in patients without diabetes; =0.01). Across these 3 end points, the effect of empagliflozin did not differ in patients with prediabetes or normoglycemia (33% and 18% of the patient population, respectively). When investigated as a continuous variable, baseline hemoglobin A1c did not modify the effects on the primary outcome (=0.26). There was no increased risk of hypoglycemic events in either subgroup as compared with placebo.
In patients with heart failure and a preserved ejection fraction enrolled in the EMPEROR-Preserved (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction), empagliflozin significantly reduced the risk of heart failure outcomes irrespective of diabetes status at baseline.
URL: https://www.
gov; Unique identifier: NCT03057951.
恩格列净可改善射血分数保留的心力衰竭患者的预后，但该药在伴或不伴糖尿病患者中的疗效是否一致仍有待阐明。
将 II 级至 IV 级心力衰竭且左心室射血分数＞40%的患者随机分至加用恩格列净 10mg 或安慰剂的标准治疗组。我们进行了一项预设分析，比较了恩格列净与安慰剂在伴或不伴糖尿病患者中的疗效。
5988 例入组患者中，49%（2938 例）患有糖尿病。伴糖尿病患者的主要结局（首次因心力衰竭住院或心血管死亡）、心力衰竭总住院次数和估算肾小球滤过率下降的风险更高。无论糖尿病状态如何，恩格列净均降低了主要结局的发生率（伴糖尿病患者的风险比为 0.79[95%CI，0.670.94]，不伴糖尿病患者的风险比为 0.78[95%CI，0.640.95]；=0.92）。恩格列净降低心力衰竭总住院次数的效果在伴或不伴糖尿病患者中也一致。在伴或不伴糖尿病患者中，恩格列净减轻估算肾小球滤过率下降的效果在双盲治疗期间也存在，尽管在伴糖尿病患者中更为明显（糖尿病患者为 1.77mL/min/1.73m，不伴糖尿病患者为 0.98mL/min/1.73m；=0.01）。在这 3 个终点中，恩格列净在糖尿病前期或血糖正常患者中的效果无差异（分别占患者人群的 33%和 18%）。当作为连续变量进行研究时，基线糖化血红蛋白 A1c 并未改变主要结局的影响（=0.26）。与安慰剂相比，无论亚组如何，低血糖事件的风险均无增加。
在射血分数保留的心力衰竭患者中进行的 EMPEROR-Preserved（恩格列净在射血分数保留的慢性心力衰竭患者中的结局试验）中，无论基线时的糖尿病状态如何，恩格列净均显著降低心力衰竭结局的风险。
gov；独特识别码：NCT03057951。
