Han Eugene, Kim Ari, Lee Sung Jae, Kim Je-Yon, Kim Jae Hyeon, Lee Woo Je, Lee Byung-Wan
Division of Endocrinology, Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
AstraZeneca, Seoul, Korea.
Diabetes Ther. 2018 Aug;9(4):1689-1701. doi: 10.1007/s13300-018-0470-9. Epub 2018 Jul 11.
Sodium glucose co-transporter 2 (SGLT2) inhibitors, such as dapagliflozin, have demonstrated favorable effects in patients with type 2 diabetes (T2D). However, there are limited reports in the literature regarding the glucose-lowering effects of SGLT2 inhibitors in actual clinical settings.
The post-marketing surveillance data from a longitudinal prospective study of 2007 patients with T2D who were prescribed dapagliflozin (10 mg/day) were analyzed (ClinicalTrials.gov, NCT02252224).
After 12 weeks of dapagliflozin treatment, glycated hemoglobin (HbA1c) and body mass index were significantly decreased (P < 0.001) from 8.1 ± 1.3% to 7.5 ± 1.2% and from 28.1 ± 4.4 to 27.6 ± 4.2 kg/m, respectively. Both body weight and HbA1c were reduced in 67.7% of patients, and HbA1c was lowered in 75.1%. Younger age, male sex, shorter diabetes duration, higher baseline HbA1c and estimated glomerular filtration rate (eGFR), and having dapagliflozin as add-on therapy were associated with stronger HbA1c reductions after dapagliflozin use (all P < 0.05). Moreover, subgroup analysis of eGFR of subjects with renal hyperfiltration (eGFR ≥ 120 ml/min/1.73 m) showed the largest reduction in glucose level (% change, - 9.5; 95% CI - 6.8 to - 12.3 for HbA1c; P < 0.001). Multivariable logistic regression analysis showed that recent T2D diagnosis and higher HbA1c at baseline in patients who received an add-on regimen of dapagliflozin were statistically significantly associated with a dapagliflozin response (all P < 0.05).
Dapagliflozin provides benefits for glycemic control and body weight. Patients in a relatively early stage of the course of diabetes with renal hyperfiltration might be more suitable for and gain maximal benefit from dapagliflozin treatment.
ClinicalTrials.gov identifier, NCT02252224.
AstraZeneca.
钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂，如达格列净，已在2型糖尿病（T2D）患者中显示出良好疗效。然而，关于SGLT2抑制剂在实际临床环境中的降糖效果，文献报道有限。
分析了一项对2007例接受达格列净（10毫克/天）治疗的T2D患者进行的纵向前瞻性研究的上市后监测数据（ClinicalTrials.gov，NCT02252224）。
达格列净治疗12周后，糖化血红蛋白（HbA1c）和体重指数显著降低（P<0.001），分别从8.1±1.3%降至7.5±1.2%，从28.1±4.4降至27.6±4.2千克/米²。67.7%的患者体重和HbA1c均降低，75.1%的患者HbA1c降低。年龄较小、男性、糖尿病病程较短、基线HbA1c和估计肾小球滤过率（eGFR）较高以及将达格列净作为附加治疗与使用达格列净后HbA1c降低幅度更大相关（所有P<0.05）。此外，对肾高滤过（eGFR≥120毫升/分钟/1.73米²）受试者的eGFR进行亚组分析显示，血糖水平降低幅度最大（变化百分比，-9.5；HbA1c的95%置信区间为-6.8至-12.3；P<0.001）。多变量逻辑回归分析显示，近期诊断为T2D且接受达格列净附加治疗方案的患者基线时HbA1c较高与达格列净反应在统计学上显著相关（所有P<0.05）。
达格列净对血糖控制和体重有益。处于糖尿病病程相对早期且有肾高滤过的患者可能更适合使用达格列净治疗并从中获得最大益处。
ClinicalTrials.gov标识符，NCT02252224。
阿斯利康。
