Hospitais da Universidade de Coimbra, Praceta Prof. Mota Pinto, 3000-075 Coimbra, Portugal.
International Diabetes Center at Park Nicollet, Minneapolis, MN, USA.
Age Ageing. 2019 Nov 1;48(6):859-866. doi: 10.1093/ageing/afz096.
The risks of cardio-renal complications of diabetes increase with age. In the EMPA-REG OUTCOME® trial, empagliflozin reduced cardiovascular (CV) mortality by 38% in patients with type 2 diabetes (T2D) and CV disease. Here we compare outcomes with empagliflozin in older patients in EMPA-REG OUTCOME.
Patients with T2D and CV disease were randomised to empagliflozin 10 or 25 mg, or placebo plus standard of care. In post hoc analyses, risks of 3-point major adverse CV events (3P-MACE: composite of CV death, non-fatal myocardial infarction (MI) or non-fatal stroke), CV death, hospitalisation for heart failure, all-cause mortality, all-cause hospitalisation and incident/worsening nephropathy were evaluated for empagliflozin versus placebo by baseline age (<65, 65 to <75, ≥75 years). Adverse events (AEs) were analysed descriptively.
Effect of empagliflozin on all outcomes was consistent across age categories (P ≥ 0.05 for interactions) except 3P-MACE. The 3P-MACE hazard ratios (HRs) were 1.04 (95% confidence interval [CI] 0.84, 1.29), 0.74 (0.58, 0.93) and 0.68 (0.46, 1.00) in patients aged <65, 65 to <75, and ≥75 years, respectively (P = 0.047 for treatment-by-age group interaction). Corresponding CV death HRs were 0.72 (95% CI 0.52, 1.01), 0.54 (0.37, 0.79) and 0.55 (0.32, 0.94), respectively (P = 0.484 for treatment-by-age group interaction). Across age categories, empagliflozin AEs reflected its known safety profile. Rates of bone fractures, renal AEs and diabetic ketoacidosis were similar between empagliflozin and placebo across age categories.
In the EMPA-REG OUTCOME trial, empagliflozin reduced risks of CV mortality, heart failure and renal outcomes, supporting its cardio-renal benefits in older patients.
糖尿病的心脏-肾脏并发症风险随年龄增长而增加。在 EMPA-REG OUTCOME 试验中，恩格列净可降低 2 型糖尿病（T2D）和心血管疾病患者的心血管（CV）死亡率 38%。在此，我们比较了 EMPA-REG OUTCOME 中年龄较大的患者使用恩格列净的结果。
将 T2D 和心血管疾病患者随机分配至恩格列净 10 或 25mg 组、或安慰剂加标准治疗组。在事后分析中，通过基线年龄（<65 岁、65 至<75 岁、≥75 岁）评估恩格列净与安慰剂相比的 3 点主要不良心血管事件（3P-MACE：心血管死亡、非致死性心肌梗死（MI）或非致死性卒中复合终点）、CV 死亡、心力衰竭住院、全因死亡率、全因住院和新发/恶化的肾病风险。描述性分析不良事件（AE）。
除 3P-MACE 外，恩格列净对所有结局的影响在各年龄组间一致（交互作用 P≥0.05）。<65 岁、65 至<75 岁和≥75 岁患者的 3P-MACE 风险比（HR）分别为 1.04（95%置信区间 [CI] 0.84，1.29）、0.74（0.58，0.93）和 0.68（0.46，1.00）（治疗与年龄组间交互作用 P=0.047）。相应的 CV 死亡 HR 分别为 0.72（95% CI 0.52，1.01）、0.54（0.37，0.79）和 0.55（0.32，0.94）（治疗与年龄组间交互作用 P=0.484）。在各年龄组中，恩格列净的 AE 反映了其已知的安全性特征。在各年龄组中，恩格列净和安慰剂的骨折、肾脏 AE 和糖尿病酮症酸中毒发生率相似。
在 EMPA-REG OUTCOME 试验中，恩格列净降低了 CV 死亡率、心力衰竭和肾脏结局的风险，支持其在老年患者中的心脏-肾脏获益。
