Objective To investigate the association between sodium-glucose cotransporter-2 (SGLT-2) inhibitor use and risk of all cause mortality among patients with heart failure with reduced ejection fraction. Design Linked database study. Setting National registers in Denmark, July 2020 to June 2023. Participants Patients with heart failure, aged ≥45 years, with left ventricular ejection fraction ≤40%. Main outcome measures The primary outcome was all cause mortality comparing initiation and continued treatment with SGLT-2 inhibitors versus continued treatment with other standard-of-care heart failure drugs and non-use of SGLT-2 inhibitors; secondary outcomes were the composite of cardiovascular mortality or admission to hospital with heart failure and its individual components. Hazard ratios were estimated using Cox regression adjusted using inverse probability of treatment weighting based on propensity scores. Results The study included 6776 patients who started SGLT-2 inhibitors (79% dapagliflozin; 21% empagliflozin) and 14 686 patients who remained on other standard-of-care heart failure drugs and did not use SGLT-2 inhibitors. Most SGLT-2 inhibitor users were male (70%), the mean age was 71.2 (standard deviation 10.6) years, and 20% had type 2 diabetes. During follow-up, 374 deaths occurred among SGLT-2 inhibitor users (incidence rate 5.8 per 100 person years) and 1602 among non-users (8.5 per 100 person years). The weighted hazard ratio for all cause mortality was 0.75 (95% confidence interval 0.66 to 0.85); the weighted incidence rate difference was −1.6 (95% confidence interval −2.5 to −0.8) per 100 person years. Secondary outcomes showed a weighted hazard ratio of 0.94 (0.85 to 1.04) for cardiovascular mortality or hospital admission with heart failure, 0.77 (0.64 to 0.92) for cardiovascular mortality, and 1.03 (0.92 to 1.15) for hospital admission with heart failure. The weighted hazard ratios for all cause mortality were consistent in patients with and without diabetes (0.73 (0.58 to 0.91) and 0.73 (0.63 to 0.85); P=0.99). Conclusions In this large database study among patients with heart failure with reduced ejection fraction, SGLT-2 inhibitor use was associated with a 25% lower risk of all cause mortality, supporting their effectiveness in routine clinical practice. Data from the Danish nationwide registers may be obtained from a third party and are not publicly available. According to Danish data protection regulations, data cannot be shared publicly.

中文翻译：

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SGLT-2 抑制剂和射血分数降低心力衰竭患者的死亡率：链接数据库研究


目的 探讨钠-葡萄糖协同转运蛋白-2 （SGLT-2） 抑制剂使用与射血分数降低心力衰竭患者全因死亡风险之间的相关性。设计链接数据库研究。在 2020 年 7 月至 2023 年 6 月期间，在丹麦设置国家登记册。参与者 心力衰竭患者，年龄 ≥45 岁，左心室射血分数 ≤40%。主要结局指标 主要结局是全因死亡率，比较开始使用和继续使用 SGLT-2 抑制剂与继续使用其他标准护理心力衰竭药物和不使用 SGLT-2 抑制剂;次要结局是心血管死亡率或心力衰竭住院及其各个组成部分的复合。使用 Cox 回归估计风险比，并使用基于倾向评分的治疗加权的逆概率进行调整。结果 该研究包括 6776 例开始使用 SGLT-2 抑制剂 （79% 达格列净;21% 恩格列净） 的患者和 14 686 例仍在服用其他标准治疗心力衰竭药物且未使用 SGLT-2 抑制剂的患者。大多数 SGLT-2 抑制剂使用者为男性 （70%），平均年龄为 71.2 （标准差 10.6） 岁，20% 患有 2 型糖尿病。在随访期间，SGLT-2 抑制剂使用者中有 374 例死亡（发病率为 5.8/100 人年），非使用者中有 1602 例死亡（发病率为 8.5/100 人年）。全因死亡率的加权风险比为 0.75 （95% 置信区间 0.66 至 0.85）;加权发病率差异为每 100 人年 -1.6 （95% 置信区间 -2.5 至 -0.8）。次要结局显示，心血管死亡率或心力衰竭住院的加权风险比为 0.94 （0.85 至 1.04），0.77 （0.64 至 0.92） 的心血管死亡率，以及 1.03 （0.92 至 1.15） 的心力衰竭入院率。糖尿病患者和非糖尿病患者全因死亡率的加权风险比是一致的 （0.73 （0.58 至 0.91） 和 0.73 （0.63 至 0.85）;P=0.99）。结论 在这项针对射血分数降低的心力衰竭患者的大型数据库研究中，使用 SGLT-2 抑制剂与全因死亡风险降低 25% 相关，支持其在常规临床实践中的有效性。丹麦全国登记册中的数据可能从第三方获得，不会公开。根据丹麦数据保护法规，数据不能公开共享。