School of Life and Health Sciences, Aston University, Birmingham, UK.
Section of Metabolic Diseases and Diabetes, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Diabetes Obes Metab. 2019 Nov;21(11):2564-2569. doi: 10.1111/dom.13841. Epub 2019 Aug 26.
Dapagliflozin is associated with greater reductions in HbA1c and weight than saxagliptin in management of type 2 diabetes mellitus (T2DM). The present post hoc analyses compared the durability of these effects over short- and long-term follow-up in patients with T2DM who were inadequately controlled with metformin (≥1500 mg/day) and who were receiving either dapagliflozin (10 mg/day) or saxagliptin (5 mg/day). Failure of glycaemiccontrol was assessed using the slope of the change in HbA1c from baseline-over-time regression line (coefficient of failure [CoF]). CoF was compared directly (dapagliflozin vs saxagliptin) over the short term (NCT01606007, 24 weeks) and indirectly (placebo-adjusted) over the long term (NCT00528879 and NCT00121667, 102 weeks). A low CoF value indicated greater durability. CoF was lower for dapagliflozin versus saxagliptin over 18-24 weeks (-1.38%/year; 95% CI, -2.41 to -0.35; P = .009) and 20-102 weeks (-0.37%/year; 95% CI, -0.73 to -0.02; P = .04). Fewer dapagliflozin-treated patients versus saxagliptin-treated patients required rescue medication or discontinued the study because of failure to achieve glycaemic control at 24 weeks (3.4% vs 9.4%; P = .0191). In patients with T2DM who were inadequately controlled with metformin, dapagliflozin was associated with greater durability of glycaemic control than saxagliptin over 18-24 and 20-102 weeks.
达格列净与沙格列汀相比,在二甲双胍控制不佳(≥1500mg/天)的 2 型糖尿病(T2DM)患者中,能更显著降低糖化血红蛋白(HbA1c)和体重。本事后分析比较了这些疗效在接受达格列净(10mg/天)或沙格列汀(5mg/天)治疗的 T2DM 患者短期和长期随访中的持久性。采用从基线到时间回归线的 HbA1c 变化斜率(失效系数 [CoF])评估血糖控制失败。直接比较 CoF(达格列净 vs 沙格列汀)短期(NCT01606007,24 周)和间接(安慰剂调整)长期(NCT00528879 和 NCT00121667,102 周)。CoF 值较低表示持久性较好。达格列净治疗组的 CoF 低于沙格列汀治疗组,在 18-24 周时为-1.38%/年(95%CI,-2.41 至-0.35;P=0.009),在 20-102 周时为-0.37%/年(95%CI,-0.73 至-0.02;P=0.04)。在 24 周时,达格列净治疗组与沙格列汀治疗组相比,需要挽救药物或因血糖控制失败而停止研究的患者较少(3.4%比 9.4%;P=0.0191)。在二甲双胍控制不佳的 T2DM 患者中,达格列净在 18-24 周和 20-102 周时,血糖控制的持久性优于沙格列汀。