Jang Ha Young, Kim In-Wha, Oh Jung Mi
College of Pharmacy, Gachon University, Incheon 21936, Republic of Korea.
College of Pharmacy, Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul 08826, Republic of Korea.
Pharmaceutics. 2023 Sep 27;15(10):2394. doi: 10.3390/pharmaceutics15102394.
Empagliflozin has been shown to reduce cardiovascular morbidity and mortality in patients with type 2 diabetes. Various research on its efficacy in patients with chronic kidney disease (CKD) have been actively conducted. So far, few studies have investigated the safety of these adverse effects specifically in Asians with CKD. We aim to address these safety concerns on a patient population of Asian CKD patients using real-world data.
We conducted a retrospective cohort study using health insurance data from the Korean Health Insurance Review & Assessment Service and compared safety outcomes between empagliflozin and sitagliptin in 26,347 CKD patients diagnosed with diabetes. Adverse outcomes, including major adverse cardiac events (MACEs), all-cause mortality, myocardial infarction (MI), stroke, and hospitalization for heart failure (HHF), among others, were assessed.
Among a 1:1 matched cohort (6170 on empagliflozin, 6170 on sitagliptin), empagliflozin was associated with a significant reduction in MACEs, all-cause mortality, MI, hospitalization for unstable angina, coronary revascularization, HHF, hypoglycemic events, and urinary tract infections, but increased the risk of genital tract infections. No significant changes were observed for transient ischemic attack, acute kidney injury, volume depletion, diabetic ketoacidosis, thromboembolic events, and fractures.
The usage of empagliflozin in diabetic CKD patients shows a significant reduction in many adverse outcomes compared to sitagliptin, but with an increased risk of genital tract infections. These findings provide evidence for future clinical decision-making around the use of empagliflozin in Asian CKD patients.
恩格列净已被证明可降低2型糖尿病患者的心血管发病率和死亡率。关于其在慢性肾脏病（CKD）患者中的疗效，已开展了各种研究。到目前为止，很少有研究专门调查这些不良反应在亚洲CKD患者中的安全性。我们旨在利用真实世界数据，解决亚洲CKD患者群体中的这些安全问题。
我们使用韩国健康保险审查与评估服务机构的健康保险数据进行了一项回顾性队列研究，比较了26347例诊断为糖尿病的CKD患者中恩格列净和西格列汀的安全结局。评估了包括主要不良心脏事件（MACE）、全因死亡率、心肌梗死（MI）、中风和心力衰竭住院（HHF）等不良结局。
在1:1匹配队列中（恩格列净组6170例，西格列汀组6170例），恩格列净与MACE、全因死亡率、MI、不稳定型心绞痛住院、冠状动脉血运重建、HHF、低血糖事件和尿路感染的显著降低相关，但增加了生殖道感染的风险。短暂性脑缺血发作、急性肾损伤、容量耗竭、糖尿病酮症酸中毒、血栓栓塞事件和骨折方面未观察到显著变化。
与西格列汀相比，糖尿病CKD患者使用恩格列净可显著降低许多不良结局，但生殖道感染风险增加。这些发现为未来亚洲CKD患者使用恩格列净的临床决策提供了依据。
