Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark
Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
BMJ. 2024 Nov 6;387:e080925. doi: 10.1136/bmj-2024-080925.
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.
Linked database study.
National registers in Denmark, July 2020 to June 2023.
Patients with heart failure, aged ≥45 years, with left ventricular ejection fraction ≤40%.
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.
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).
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.
研究钠-葡萄糖共转运蛋白-2（SGLT-2）抑制剂的使用与射血分数降低的心力衰竭患者全因死亡率之间的关联。
数据库链接研究。
丹麦全国登记处，2020 年 7 月至 2023 年 6 月。
年龄≥45 岁、左心室射血分数≤40%的心力衰竭患者。
主要结局为比较 SGLT-2 抑制剂起始和持续治疗与其他标准心力衰竭药物持续治疗和不使用 SGLT-2 抑制剂的全因死亡率；次要结局为心血管死亡率或心力衰竭入院的复合结局及其各个组成部分。使用基于倾向评分的逆概率治疗加权的 Cox 回归估计风险比。
研究纳入了 6776 名开始使用 SGLT-2 抑制剂（79%达格列净；21%恩格列净）的患者和 14686 名继续使用其他标准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 人死亡（发生率为每 100 人年 5.8 例），非使用者中有 1602 人死亡（发生率为每 100 人年 8.5 例）。全因死亡率的加权风险比为 0.75（95%置信区间 0.66 至 0.85）；加权发生率差异为每 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入院的加权风险比为 0.94（0.85 至 1.04），心血管死亡率为 0.77（0.64 至 0.92），心力衰竭入院为 1.03（0.92 至 1.15）。在有和没有糖尿病的患者中，全因死亡率的加权风险比一致（0.73（0.58 至 0.91）和 0.73（0.63 至 0.85）；P=0.99）。
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，SGLT-2 抑制剂的使用与全因死亡率降低 25%相关，支持其在常规临床实践中的有效性。
