Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St., BC-3030, Boston, MA 02120, USA.
Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, USA.
Eur Heart J. 2023 Jun 25;44(24):2216-2230. doi: 10.1093/eurheartj/ehad273.
The effectiveness of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with heart failure (HF) in routine clinical practice is not extensively studied. This study aimed to evaluate the comparative effectiveness of SGLT2i vs. sitagliptin in older adults with HF and type 2 diabetes and to investigate whether there were any differences between agents within the SGLT2i class or for reduced and preserved ejection fraction.
Using Medicare claims data (April 2013 to December 2019), 16 253 SGLT2i initiators vs. 43 352 initiators of sitagliptin aged ≥65 years with type 2 diabetes and HF were included. The primary outcome was a composite of all-cause mortality, hospitalization for HF or urgent visit requiring intravenous diuretics; secondary outcomes included its individual components. Propensity score fine stratification weighted Cox regression was used to adjust for 100 pre-exposure characteristics. Mean age was 74 years; 49.8% were women. Initiation of SGLT2i vs. sitagliptin was associated with a lower risk of the primary composite outcome [adjusted hazard ratio (HR) 0.72; 95% confidence interval 0.67-0.77]. The adjusted HRs were 0.70 (0.63-0.78) for all-cause mortality, 0.64 (0.58-0.70) for hospitalization for HF, and 0.77 (0.69-0.86) for urgent visit requiring intravenous diuretics. Similar associations with the primary composite outcome were observed for all three agents within the SGLT2i class, for reduced and preserved ejection fraction, and subgroups based on demographics, comorbidities, and other HF treatments. Bias-calibrated HRs for the primary endpoint using negative and positive control outcomes ranged between 0.81 and 0.89, suggesting that the observed benefit could not be fully explained by residual confounding.
In routine US clinical practice, SGLT2i demonstrated robust clinical effectiveness in older adults with HF and type 2 diabetes compared with sitagliptin, with no evidence of heterogeneity across the SGLT2i class or across ejection fraction.
在常规临床实践中，钠-葡萄糖共转运蛋白 2 抑制剂（SGLT2i）在心力衰竭（HF）患者中的疗效尚未得到广泛研究。本研究旨在评估 SGLT2i 与西格列汀在老年 HF 合并 2 型糖尿病患者中的疗效比较，并探讨 SGLT2i 类药物或射血分数降低和保留的 HF 患者中，不同药物之间是否存在差异。
使用医疗保险索赔数据（2013 年 4 月至 2019 年 12 月），纳入了 16253 例 SGLT2i 起始治疗患者和 43352 例西格列汀起始治疗患者，年龄均≥65 岁，且患有 2 型糖尿病和 HF。主要结局是全因死亡率、HF 住院或需要静脉利尿剂的紧急就诊的复合结局；次要结局包括其各个组成部分。采用倾向评分精细分层加权 Cox 回归校正 100 项暴露前特征。平均年龄为 74 岁，49.8%为女性。与起始西格列汀相比，SGLT2i 起始治疗与较低的主要复合结局风险相关[校正后的危险比（HR）0.72；95%置信区间 0.67-0.77]。全因死亡率的校正 HR 为 0.70（0.63-0.78），HF 住院的校正 HR 为 0.64（0.58-0.70），需要静脉利尿剂的紧急就诊的校正 HR 为 0.77（0.69-0.86）。在 SGLT2i 类药物中，对于所有三种药物，对于射血分数降低和保留的 HF 患者，以及基于人口统计学、合并症和其他 HF 治疗的亚组，均观察到与主要复合结局相似的相关性。使用阴性和阳性对照结局进行偏倚校正的主要终点 HR 介于 0.81 至 0.89 之间，这表明观察到的益处不能完全用残余混杂来解释。
在常规美国临床实践中，与西格列汀相比，SGLT2i 为老年 HF 合并 2 型糖尿病患者提供了稳健的临床疗效，且在 SGLT2i 类药物或射血分数中无异质性。
