钠-葡萄糖协同转运蛋白-2抑制剂(SGLT-2is)适用于有或没有2型糖尿病动脉粥样硬化性心血管疾病的患者,慢性肾病,或者心力衰竭.上市后的监测数据已经确定了许多安全信号,值得进一步调查。我们旨在比较SGLT-2i和胰高血糖素样肽-1受体激动剂(GLP-1RA)的安全性。使用全国退伍军人健康管理局的数据库,本研究确定了在2013年4月1日至2020年9月1日期间新开始使用SGLT-2i或GLP-1RA的2型糖尿病患者.主要结果是截肢的发生率,膝下截肢(BKA),所有临床骨折,髋部骨折,Fournier坏疽,急性胰腺炎,糖尿病酮症酸中毒(DKA),严重尿路感染(UTI),静脉血栓栓塞(VTE)。在治疗组之间比较所有结果。Cox比例风险模型用于评估调整后的风险比(aHRs)以进行比较分析。总共确定了70,694名倾向匹配的SGLT-2i和GLP-1RA新用户。SGLT-2抑制剂的用途,与GLP-1RA相比,与截肢率的增加无关(AHR1.02,95%置信区间[CI]0.82至1.27),BKA(AHR1.05,95%CI0.84至1.32),所有临床骨折(AHR0.94,95%CI0.86至1.03),髋部骨折(AHR0.82,95%CI0.50至1.32),DKA(AHR1.66,95%CI0.97至2.85),VTE(AHR1.02,95%CI0.80至1.30),急性胰腺炎(AHR1.02,95%CI0.80至1.30),和Fournier坏疽(aHR0.9295%CI0.61至1.38)。SGLT-2i组的严重尿路感染发生率低于GLP-1RA组(aHR0.74,95%CI0.64至0.84)。这项现实世界的研究发现,与GLP-1RA相比,SGLT-2i的使用并未增加截肢率,BKA,临床骨折,髋部骨折,Fournier坏疽,急性胰腺炎,DKA,严重的UTI,和退伍军人患者的VTE。
Sodium-glucose cotransporter-2 inhibitors (SGLT-2is) are indicated in patients with or without type 2 diabetes mellitus atherosclerotic cardiovascular disease, chronic kidney disease, or heart failure. Postmarket surveillance data have identified many safety signals which warrants further investigation. We aimed to compare the safety of SGLT-2i and glucagon-like peptide-1 receptor agonists (GLP-1RA). Using the Veterans Health Administration nationwide database, patients with type 2 diabetes mellitus who were newly initiated on a SGLT-2i or GLP-1RA between April 1, 2013 and September 1, 2020 were identified. The primary outcome was the incidence of any amputation, below-knee amputation (BKA), all clinical fractures, hip fracture, Fournier gangrene, acute pancreatitis, diabetic ketoacidosis (DKA), serious urinary tract infections (UTIs), and venous thromboembolism (VTE). All outcomes were compared between the treatment groups. Cox proportional hazard models were used to estimate adjusted hazard ratios (aHRs) for the comparative analysis. A total of 70,694 propensity-matched new users of SGLT-2i and GLP-1RA were identified. The use of SGLT-2 inhibitors, compared with GLP-1RA, was not associated with an increased rate of any amputation (aHR 1.02, 95% confidence interval [CI] 0.82 to 1.27), BKA (aHR 1.05, 95% CI 0.84 to 1.32), all clinical fractures (aHR 0.94, 95% CI 0.86 to 1.03), hip fractures (aHR 0.82, 95% CI 0.50 to 1.32), DKA (aHR 1.66, 95% CI 0.97 to 2.85), VTE (aHR 1.02, 95% CI 0.80 to 1.30), acute pancreatitis (aHR 1.02, 95% CI 0.80 to 1.30), and Fournier gangrene (aHR 0.92 95% CI 0.61 to 1.38). Lower rates of serious UTIs were observed in the SGLT-2i group than in the GLP-1RA group (aHR 0.74, 95% CI 0.64 to 0.84). This real-world
study found that SGLT-2i use compared with GLP-1RA did not increase the rate of amputation, BKA, clinical fractures, hip fracture, Fournier gangrene, acute pancreatitis, DKA, serious UTIs, and VTE in veteran patients.