Department of Pharmacy, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
J Diabetes Res. 2022 May 23;2022:2420857. doi: 10.1155/2022/2420857. eCollection 2022.
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce blood glucose, blood pressure, and body weight in patients with type 2 diabetes (T2D). However, the comparative long-term effectiveness and safety of SGLT2i among similar drugs, administered at different doses, have not been assessed. In this study, we compared the long-term effectiveness and safety of SGLT2i (dapagliflozin versus empagliflozin) as add-on therapy to hypoglycemic agents in T2D patients.
This study was a single-center, 3-year, retrospective, observational study. For all patients in the study, drugs were evaluated for safety by documenting adverse drug reactions. The primary effectiveness was evaluated as the difference between hemoglobin A1c (HbA1c) values obtained at baseline and those obtained after 36 months of treatment. The proportion of participants with HbA1c levels <7.0% and <6.5% was also analyzed.
In total, 680 patients were enrolled in this study. Using propensity score matching, 234 patients each from the dapagliflozin and empagliflozin groups were selected based on patient characteristics. After 36 months of treatment, clinical parameters (including HbA1c, fasting plasma glucose, alanine aminotransferase, triglyceride levels, body weight, and systolic blood pressure) decreased significantly in these groups. The changes from the baseline for the physiological values and clinical parameters did not vary among the different dose groups of SGLT2i. The incidence of adverse drug reactions was approximately 7-8%. All patients with observed serious adverse reactions were hospitalized for urinary tract infections.
Our study showed that the long-term continuous use of either dapagliflozin or empagliflozin as add-on therapy to hypoglycemic drugs for T2D patients is synergistically effective for lowering blood glucose, reducing body weight, and stabilizing blood pressure. Additionally, there was no significant difference in efficacy between dapagliflozin and empagliflozin, even with the administration of different doses of these agents.
钠-葡萄糖共转运蛋白 2 抑制剂（SGLT2i）可降低 2 型糖尿病（T2D）患者的血糖、血压和体重。然而，不同剂量的类似药物作为附加治疗药物时，SGLT2i 的长期有效性和安全性尚未得到评估。在这项研究中，我们比较了 SGLT2i（达格列净与恩格列净）作为 T2D 患者降糖药物附加治疗的长期有效性和安全性。
这是一项单中心、3 年、回顾性、观察性研究。对于研究中的所有患者，通过记录药物不良反应来评估药物安全性。主要疗效评估指标为基线时与治疗 36 个月后糖化血红蛋白（HbA1c）值的差值。同时还分析了 HbA1c 水平＜7.0%和＜6.5%的患者比例。
本研究共纳入 680 例患者。通过倾向评分匹配，根据患者特征，从达格列净组和恩格列净组中各选择 234 例患者。经过 36 个月的治疗，两组患者的临床参数（包括 HbA1c、空腹血糖、丙氨酸氨基转移酶、甘油三酯水平、体重和收缩压）均显著降低。SGLT2i 不同剂量组的生理值和临床参数的变化从基线开始没有差异。药物不良反应的发生率约为 7-8%。所有观察到严重不良反应的患者均因尿路感染住院。
本研究表明，长期连续使用达格列净或恩格列净作为 T2D 患者降糖药物的附加治疗，在降低血糖、减轻体重和稳定血压方面具有协同作用。此外，即使给予不同剂量的药物，达格列净和恩格列净的疗效也没有显著差异。
