Clinical Epidemiology Division, Department of Medicine, Karolinska Institutet, Solna, Stockholm 171 77, Sweden.
Department of Epidemiology Research, Statens Serum Institut, DK-2300 Copenhagens, Denmark.
Eur Heart J Cardiovasc Pharmacother. 2024 Aug 14;10(5):432-443. doi: 10.1093/ehjcvp/pvae045.
To assess the comparative cardiovascular and renal effectiveness and safety of empagliflozin vs. dapagliflozin among patients with type 2 diabetes in routine clinical practice.
Cohort study using data from nationwide registers in Sweden, Denmark, and Norway, from June 2014 to June 2021 included 141 065 new users of empagliflozin and 58 306 new users of dapagliflozin. Coprimary outcomes were major cardiovascular events (myocardial infarction, stroke, and cardiovascular death), heart failure (hospitalization or death because of heart failure) and serious renal events (renal replacement therapy, hospitalization for renal events, and death from renal causes). Secondary outcomes were the individual components of the primary outcomes, any cause death, and diabetic ketoacidosis. Use of empagliflozin vs. dapagliflozin was associated with similar risk of major cardiovascular events [adjusted incidence rate: 15.9 vs. 15.8 events per 1000 person-years; HR 1.02, (95% confidence interval 0.97-1.08)], heart failure [6.5 vs. 6.3 events per 1000 person-years; HR 1.05 (0.97-1.14)] and serious renal events [3.7 vs. 4.1 events per 1000 person-years; HR 0.97 (0.87-1.07)]. In secondary outcome analyses, the HRs for use of empagliflozin vs. dapagliflozin were 1.00 (0.93-1.07) for myocardial infarction, 1.03 (0.95-1.12) for stroke, 1.01 (0.92-1.13) for cardiovascular death, 1.06 (1.00-1.11) for any cause death, 0.77 (0.60-0.99) for renal replacement therapy, 1.20 (0.75-1.93) for renal death, 1.01 (0.90-1.12) for hospitalization for renal events and 1.12 (0.94-1.33) for diabetic ketoacidosis.
Use of empagliflozin and dapagliflozin was associated with similar risk of cardiovascular and renal outcomes, mortality, and diabetic ketoacidosis.
评估在 2 型糖尿病患者的常规临床实践中,恩格列净与达格列净的心血管和肾脏的有效性和安全性。
本队列研究使用了来自瑞典、丹麦和挪威全国登记处的数据,纳入了 2014 年 6 月至 2021 年 6 月期间 141065 例新使用恩格列净的患者和 58306 例新使用达格列净的患者。主要复合终点是主要心血管事件(心肌梗死、中风和心血管死亡)、心力衰竭(因心力衰竭住院或死亡)和严重肾脏事件(肾脏替代治疗、因肾脏事件住院和因肾脏原因死亡)。次要终点是主要结局的各个组成部分、任何原因的死亡和糖尿病酮症酸中毒。与达格列净相比,使用恩格列净与主要心血管事件的风险相似[校正发病率:每 1000 人年 15.9 与 15.8 例;HR 1.02(95%置信区间 0.97-1.08)]、心力衰竭[6.5 与 6.3 例每 1000 人年;HR 1.05(0.97-1.14)]和严重肾脏事件[3.7 与 4.1 例每 1000 人年;HR 0.97(0.87-1.07)]。在次要结局分析中,与达格列净相比,恩格列净的 HR 为 1.00(0.93-1.07)用于心肌梗死、1.03(0.95-1.12)用于中风、1.01(0.92-1.13)用于心血管死亡、1.06(1.00-1.11)用于任何原因的死亡、0.77(0.60-0.99)用于肾脏替代治疗、1.20(0.75-1.93)用于肾脏死亡、1.01(0.90-1.12)用于肾脏事件住院和 1.12(0.94-1.33)用于糖尿病酮症酸中毒。
使用恩格列净和达格列净与心血管和肾脏结局、死亡率和糖尿病酮症酸中毒的风险相似。