Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (A.P., M.V., B.L.C., I.J.K., A.S.D., S.D.S.).
Universidad Nacional de Córdoba, Córdoba, Argentina (F.A.M.).
Circ Heart Fail. 2022 Oct;15(10):e010080. doi: 10.1161/CIRCHEARTFAILURE.122.010080. Epub 2022 Aug 27.
The prevalence of heart failure with mildly reduced or preserved ejection fraction markedly increases with age, with older individuals disproportionately facing excess risk for mortality and hospitalization.
The DELIVER trial (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure) randomized patients with New York Heart Association functional class II-IV and left ventricular ejection fraction >40% to either dapagliflozin or placebo for a median follow-up period of 2.3 years. We examined efficacy and safety outcomes by age categories (<55, 55-64, 65-74, and ≥75 years) and across age as a continuous measure.
Among 6263 randomized patients (aged 40-99 years, mean age 71.7±9.6 years), 338 (5.4%) were <55 years, 1007 (16.1%) were 55-64 years, 2326 (37.1%) were 65 to 74 years, and 2592 (41.4%) were ≥75 years. Dapagliflozin reduced the risk of the primary composite outcome compared with placebo in all age categories (=0.95) and across the age spectrum as a continuous function (=0.76). Similar benefits were observed for the components of the primary outcome, with no significant interaction between randomized treatment and age category. Adverse events occurred more frequently with increasing age, but there were no significant differences in predefined safety outcomes between patients randomized to dapagliflozin and placebo across all age categories.
In patients with heart failure and mildly reduced or preserved ejection fraction enrolled in DELIVER, dapagliflozin reduced the combined risk of cardiovascular death or worsening heart failure events across the spectrum of age, with a consistent safety profile, including among the traditionally under-treated older segment of patients ≥75 years.
URL: https://www.
gov; Unique identifier: NCT03619213.
心力衰竭伴轻度射血分数降低或射血分数保留的患病率随年龄增长显著增加，老年人面临过度死亡和住院风险的比例更高。
DELIVER 试验（达格列净评估改善射血分数保留心力衰竭患者的生活）将纽约心脏协会功能分级 II-IV 级和左心室射血分数>40%的患者随机分为达格列净或安慰剂组，中位随访时间为 2.3 年。我们通过年龄类别（<55 岁、55-64 岁、65-74 岁和≥75 岁）和年龄连续测量来检查疗效和安全性结局。
在 6263 名随机患者（年龄 40-99 岁，平均年龄 71.7±9.6 岁）中，338 名（5.4%）<55 岁，1007 名（16.1%）55-64 岁，2326 名（37.1%）65-74 岁，2592 名（41.4%）≥75 岁。与安慰剂相比，达格列净降低了所有年龄组（=0.95）和年龄连续函数（=0.76）的主要复合结局风险。主要结局的组成部分也观察到了相似的益处，随机治疗与年龄类别之间没有显著的相互作用。随着年龄的增长，不良事件发生的频率更高，但在所有年龄组中，随机分配至达格列净和安慰剂的患者在预先定义的安全性结局方面没有显著差异。
在 DELIVER 中，心力衰竭伴轻度射血分数降低或保留的患者中，达格列净降低了心血管死亡或心力衰竭恶化事件的综合风险，具有一致的安全性特征，包括在≥75 岁的传统治疗不足的老年人群中。
gov；唯一标识符：NCT03619213。
