联合钠-葡萄糖共转运蛋白抑制剂和胰高血糖素样肽受体激动剂与单药治疗相比可改善长期生存：一项真实世界登记研究。
Combined Sodium-Glucose-Transporters Inhibitors and Glucagon-Like-Peptide Receptor Agonist Compared With Monotherapy Improves Long-Term Survival: A Real-World Registry.
机构信息
University of Santiago de Compostela, Galicia, Spain; Cardiology Department, Clinical Hospital of Santiago de Compostela, Galicia, Spain; Centro de Investigación en Red en Enfermedades Cardiovasculares, Madrid, Spain.
Centro de Investigación en Red en Enfermedades Cardiovasculares, Madrid, Spain; Centro de Salud de Milladoiro-Ames, Área Sanitaria de Santiago de Compostela, Galicia, Spain.
出版信息
Am J Med. 2024 Aug;137(8):761-769.e1. doi: 10.1016/j.amjmed.2024.04.032. Epub 2024 May 8.
BACKGROUND
The benefits of new glucose-lowering agents on cardiovascular disease have been demonstrated in randomized clinical trials. However, more evidence is required to assess the additive value of a combined therapy based on sodium-glucose transporter inhibitors (SGLT2i) and glucagon-like peptide receptor agonists (GLP1ra) in a real-world population.
METHODS
A nonconcurrent prospective study was conducted using integrated electronic medical records from primary care and hospitals obtained through "big data" technologies in a healthy area in Galicia. The study involved patients who were given SGLT2i, GLP1ra, or both treatments between January 2018 and June 2022 and were categorized as either mono- or combined therapy (SGLT2i, GLP1ra, or both). The cumulative risk for different events: hospitalization or mortality, or both, for 1) coronary artery disease, 2) heart failure, 3) cerebrovascular accident, and all-cause mortality were represented by Kaplan-Meier curves and multivariate Cox regression analysis to obtain the hazard ratio (HR) and (95% confidence interval [CI]). Validation was performed in a subpopulation with propensity score matching.
RESULTS
The patients (15,549) who were included were median (standard deviation) 68 (12) years old, with 41% of them being female and 46% experiencing obesity. The median (interquartile range) of follow-up was 19 (8-33) months. The Kaplan-Meier analysis determined that the cumulative risk for coronary artery disease and cerebrovascular accident events was similar among the 3 different therapy groups. However, the combined therapy vs SGLT2i reduced the risk of heart failure events (HR 0.69; 95% CI, 0.56-0.87) or all-cause mortality (HR 0.68; 95% CI, 0.54-0.86). Multivariate Cox regression analysis, after matching with a propensity score, confirmed the benefits of combined therapy regarding SGLT2i or GLP1ra monotherapy.
CONCLUSION
Compared with SGLT2i or GLP1ra alone, combined therapy SGLT2i + GLP1ra reduces heart failure risk and all-cause mortality in a real-world population.
背景
新的降糖药物在随机临床试验中已显示出对心血管疾病的益处。然而，为了评估基于钠-葡萄糖协同转运蛋白抑制剂（SGLT2i）和胰高血糖素样肽受体激动剂（GLP1ra）的联合治疗在真实世界人群中的附加价值，还需要更多的证据。
方法
本非同期前瞻性研究使用了加利西亚一个健康地区通过“大数据”技术从初级保健和医院获得的综合电子病历。研究纳入了 2018 年 1 月至 2022 年 6 月期间接受 SGLT2i、GLP1ra 或两种治疗的患者，并分为单药治疗（SGLT2i、GLP1ra 或两种）或联合治疗（SGLT2i+GLP1ra）。不同事件的累积风险：1）冠心病、2）心力衰竭、3）脑血管意外以及全因死亡率的住院或死亡风险，通过 Kaplan-Meier 曲线和多变量 Cox 回归分析来表示，并获得风险比（HR）和（95%置信区间[CI]）。在倾向评分匹配的亚人群中进行了验证。
结果
纳入的患者（15549 人）的中位（标准差）年龄为 68（12）岁，其中 41%为女性，46%患有肥胖症。中位（四分位距）随访时间为 19（8-33）个月。Kaplan-Meier 分析表明，3 种不同治疗组之间的冠心病和脑血管意外事件的累积风险相似。然而，与 SGLT2i 相比，联合治疗降低了心力衰竭事件（HR 0.69；95%CI，0.56-0.87）或全因死亡率（HR 0.68；95%CI，0.54-0.86）的风险。经倾向评分匹配的多变量 Cox 回归分析后，也证实了联合治疗在 SGLT2i 或 GLP1ra 单药治疗方面的获益。
结论
与 SGLT2i 或 GLP1ra 单药治疗相比，SGLT2i+GLP1ra 联合治疗可降低真实世界人群中心力衰竭风险和全因死亡率。
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