DeFronzo Ralph A, Ferrannini Ele, Schernthaner Guntram, Hantel Stefan, Elsasser Ulrich, Lee Christopher, Hach Thomas, Lund Søren S
Diabetes Division University of Texas Health Science Center San Antonio TX USA.
CNR Institute of Clinical Physiology Pisa Italy.
Endocrinol Diabetes Metab. 2018 Apr 6;1(2):e00016. doi: 10.1002/edm2.16. eCollection 2018 Apr.
To analyse the effect of baseline glycated haemoglobin (HbA) on the reduction in HbA with empagliflozin compared with sitagliptin or glimepiride in patients with type 2 diabetes.
Using regression analyses of individual patient data from two Phase III studies, we compared the change in HbA according to a unit change in baseline HbA (the slope) with empagliflozin 10 mg or 25 mg vs sitagliptin (monotherapy) after 24 weeks, and with empagliflozin 25 mg vs glimepiride (as add-on to metformin) after 52 weeks.
Steeper slopes of HbA1c decline were observed with empagliflozin 10 or 25 mg vs sitagliptin monotherapy at week 24. Regression analysis showed slopes of -0.59 (95% CI -0.70, -0.47), -0.49 (95% CI -0.62, -0.37) and -0.29 (95% CI -0.42, -0.15) for empagliflozin 10 mg, empagliflozin 25 mg and sitagliptin, respectively ( < .001 and < .05 for empagliflozin 10 mg and empagliflozin 25 mg, respectively, vs sitagliptin). Similarly, a steeper slope of HbA decline was observed with empagliflozin 25 mg vs glimepiride as add-on to metformin at week 52. Regression analysis showed slopes of - 0.52 (95% CI -0.59, -0.44) and -0.32 (95% CI -0.39, -0.25) for empagliflozin 25 mg and glimepiride, respectively ( < .001 for empagliflozin 25 mg vs glimepiride).
Incremental reductions in HbA with increasing baseline HbA are greater with empagliflozin compared with sitagliptin or glimepiride in patients with type 2 diabetes.
分析在2型糖尿病患者中，与西格列汀或格列美脲相比，恩格列净对糖化血红蛋白（HbA）降低的影响，基线糖化血红蛋白（HbA）对其有何作用。
通过对两项III期研究中个体患者数据进行回归分析，我们比较了在24周后，恩格列净10毫克或25毫克与西格列汀（单药治疗）相比，以及在52周后，恩格列净25毫克与格列美脲（作为二甲双胍的附加治疗）相比，根据基线HbA的单位变化（斜率），HbA的变化情况。
在第24周时，观察到恩格列净10毫克或25毫克与西格列汀单药治疗相比，HbA1c下降的斜率更陡。回归分析显示，恩格列净10毫克、恩格列净25毫克和西格列汀的斜率分别为-0.59（95%CI -0.70，-0.47）、-0.49（95%CI -0.62，-0.37）和-0.29（95%CI -0.42，-0.15）（恩格列净10毫克和恩格列净25毫克分别与西格列汀相比，P<0.001和P<0.05）。同样，在第52周时，观察到恩格列净25毫克与作为二甲双胍附加治疗的格列美脲相比，HbA下降的斜率更陡。回归分析显示，恩格列净25毫克和格列美脲的斜率分别为-0.52（95%CI -0.59，-0.44）和-0.32（95%CI -0.39，-0.25）（恩格列净25毫克与格列美脲相比，P<0.001）。
在2型糖尿病患者中，与西格列汀或格列美脲相比，恩格列净随着基线HbA升高，HbA的增量降低更大。
