Hong A Ram, Koo Bo Kyung, Kim Sang Wan, Yi Ka Hee, Moon Min Kyong
Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Diabetes Metab J. 2019 Oct;43(5):590-606. doi: 10.4093/dmj.2018.0134. Epub 2019 Feb 28.
This study aimed to evaluate the efficacy and safety of sodium-glucose cotransporter-2 (SGLT2) inhibitors in Korean patients who had inadequately controlled type 2 diabetes mellitus (T2DM) in real-world clinical practice.
We included 410 patients who started SGLT2 inhibitors (empagliflozin or dapagliflozin) as add-on therapy or switch therapy between February 2015 and June 2017. The primary efficacy endpoint was a change in glycosylated hemoglobin (HbA1c) from baseline to week 12. The secondary endpoints were patients achieving HbA1c <7.0% and changes in the fasting plasma glucose (FPG), lipid profiles, body weight, and blood pressure (BP).
The mean HbA1c at baseline was 8.5% (8.6% in the add-on group and 8.4% in the switch group). At week 12, the mean adjusted HbA1c decreased by -0.68% in the overall patients (<0.001), by -0.94% in the add-on group, and by -0.42% in the switch group. Significant reductions in FPG were also observed both in the add-on group and switch group (-30.3 and -19.8 mg/dL, respectively). Serum triglyceride (-16.5 mg/dL), body weight (-2.1 kg), systolic BP (-4.7 mm Hg), and diastolic BP (-1.3 mm Hg) were significantly improved in the overall patients. Approximately 18.3% of the patients achieved HbA1c <7.0% at week 12. A low incidence of hypoglycemia and genital tract infection was observed (6.3% and 2.2%, respectively).
SGLT2 inhibitors can be a suitable option as either add-on or switch therapy for Korean patients with inadequately controlled T2DM.
本研究旨在评估钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂在现实临床实践中对2型糖尿病（T2DM）控制不佳的韩国患者的疗效和安全性。
我们纳入了410例在2015年2月至2017年6月期间开始使用SGLT2抑制剂（恩格列净或达格列净）作为附加治疗或转换治疗的患者。主要疗效终点是糖化血红蛋白（HbA1c）从基线到第12周的变化。次要终点是HbA1c<7.0%的患者以及空腹血糖（FPG）、血脂谱、体重和血压（BP）的变化。
基线时平均HbA1c为8.5%（附加治疗组为8.6%，转换治疗组为8.4%）。在第12周时，总体患者的平均校正HbA1c下降了-0.68%（<0.001），附加治疗组下降了-0.94%，转换治疗组下降了-0.42%。附加治疗组和转换治疗组的FPG也均有显著降低（分别为-30.3和-19.8mg/dL）。总体患者的血清甘油三酯（-16.5mg/dL）、体重（-2.1kg）、收缩压（-4.7mmHg）和舒张压（-1.3mmHg）均有显著改善。约18.3%的患者在第12周时HbA1c<7.0%。低血糖和生殖道感染的发生率较低（分别为6.3%和2.2%）。
对于T2DM控制不佳的韩国患者，SGLT2抑制剂可作为附加治疗或转换治疗的合适选择。
