背景:与类似疗法相比,持续扩大钠-葡萄糖协同转运蛋白-2抑制剂的适应症增加了评估2型糖尿病患者使用依帕列净的心血管和肾脏疗效和安全性的重要性。
方法:EMPRISE欧洲和亚洲研究是一项非干预性队列研究,使用2014-2019年在七个欧洲(丹麦,芬兰,德国,挪威,西班牙,瑞典,英国)和四个亚洲人(以色列,Japan,韩国,台湾)国家。2型糖尿病患者服用依帕列净与服用二肽基肽酶-4抑制剂患者的倾向评分为1:1。主要终点包括心力衰竭住院,全因死亡率,心肌梗死和中风。其他心血管,肾,并检查安全性结果.
结果:在83,946对匹配的患者中,(0·7年总体平均随访时间),与二肽基肽酶-4抑制剂相比,开始使用依帕列净与心力衰竭住院风险较低相关(危害比0·70;95CI0.60~0.83).全因死亡风险(0·55;0·48至0·63),行程(0·82;0·71至0·96),终末期肾病(0·43;0·30至0·63)较低,心肌梗死的风险较低,骨折,严重低血糖,empagliflozin和二肽基肽酶-4抑制剂的引发剂之间的下肢截肢相似。与二肽基肽酶-4抑制剂相比,开始使用依帕列净与糖尿病酮症酸中毒的风险更高(1·97;1·28至3·03)。各大洲和地区的结果一致。
结论:这项EMPRISE欧洲和亚洲研究的结果通过提供与二肽基肽酶-4抑制剂相比,依帕列净有益的心肾作用和总体安全性的进一步证据,补充了先前的临床试验和现实世界的研究。
Continued expansion of indications for sodium-glucose cotransporter-2 inhibitors increases importance of evaluating cardiovascular and kidney efficacy and safety of empagliflozin in patients with type 2 diabetes compared to similar therapies.
The EMPRISE Europe and Asia study is a non-interventional cohort study using data from 2014-2019 in seven European (Denmark, Finland, Germany, Norway, Spain, Sweden, United Kingdom) and four Asian (Israel, Japan, South Korea, Taiwan) countries. Patients with type 2 diabetes initiating empagliflozin were 1:1 propensity score matched to patients initiating dipeptidyl peptidase-4 inhibitors. Primary endpoints included hospitalization for heart failure, all-cause mortality, myocardial infarction and stroke. Other cardiovascular, renal, and safety outcomes were examined.
Among 83,946 matched patient pairs, (0·7 years overall mean follow-up time), initiation of empagliflozin was associated with lower risk of hospitalization for heart failure compared to dipeptidyl peptidase-4 inhibitors (Hazard Ratio 0·70; 95% CI 0.60 to 0.83). Risks of all-cause mortality (0·55; 0·48 to 0·63), stroke (0·82; 0·71 to 0·96), and end-stage renal disease (0·43; 0·30 to 0·63) were lower and risk for myocardial infarction, bone fracture, severe hypoglycemia, and lower-limb amputation were similar between initiators of empagliflozin and dipeptidyl peptidase-4 inhibitors. Initiation of empagliflozin was associated with higher risk for diabetic ketoacidosis (1·97; 1·28 to 3·03) compared to dipeptidyl peptidase-4 inhibitors. Results were consistent across continents and regions.
Results from this EMPRISE Europe and Asia study complements previous clinical trials and real-world studies by providing further evidence of the beneficial cardiorenal effects and overall safety of empagliflozin compared to dipeptidyl peptidase-4 inhibitors.