Empagliflozin as add-on to metformin plus sulphonylurea in patients with type 2 diabetes
Empagliflozin as add-on to metformin plus sulphonylurea in patients with type 2 diabetes
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DOI：
10.1016/j.diabres.2015.05.044
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发表时间：
2015-10-01
影响因子：
5.1
通讯作者：
Broedl, Uli C.
中科院分区：
文献类型：
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作者：
Haering, Hans-Ulrich;Merker, Ludwig;Broedl, Uli C.
本研究探讨了恩格列净作为二甲双胍+磺脲类药物联合治疗2型糖尿病（T2 DM）患者的长期疗效和安全性。在接受恩格列净10 mg、恩格列净25 mg或安慰剂每日一次治疗24周的666例患者中，472例患者（70.9%）在双盲扩展试验中接受了≥ 52周的治疗。预先规定的探索性终点包括第76周时HbA（1c）、体重和血压较基线的变化。第76周时，与安慰剂相比，HbA（1c）较基线变化的校正平均差异为-0.7%（-8 mmol/mol）与恩格列净10 mg或25 mg恩格列净10 mg和25 mg组的体重分别为-1.8 kg和-1.6 kg（均p < 0.001）恩格列净10 mg组和恩格列净25 mg组的收缩压（SBP）分别为-2.2 mmHg（p = 0.021）和-2.1 mmHg（p = 0.029）。敏感性分析提供了HbA（1c）和体重的一致结果，但显示恩格列净和安慰剂之间SBP较基线的变化无显著差异。恩格列净10 mg、25 mg和安慰剂组分别有81.7%、82.0%和81.3%的患者报告了不良事件（AE）。经证实的低血糖AE（血糖
This study investigated the long-term efficacy and safety of empagliflozin as add-on to metformin plus sulphonylurea in patients with type 2 diabetes mellitus (T2DM). Of 666 patients treated with empagliflozin 10 mg, empagliflozin 25 mg or placebo once daily for 24 weeks, 472 patients (70.9%) were treated in a double-blind extension trial for >= 52 weeks. Pre-specified exploratory endpoints included changes from baseline in HbA(1c), weight and blood pressure at week 76. At week 76, adjusted mean differences versus placebo in change from baseline in HbA(1c) were -0.7% (-8 mmol/mol) with empagliflozin 10 mg or 25 mg (both p < 0.001), in weight were -1.8 kg and -1.6 kg with empagliflozin 10 mg and 25 mg, respectively (both p < 0.001), and in systolic blood pressure (SBP) were -2.2 mmHg with empagliflozin 10 mg (p = 0.021) and -2.1 mmHg with empagliflozin 25 mg (p = 0.029). Sensitivity analyses provided consistent results for HbA(1c) and weight, but showed no significant difference between empagliflozin and placebo in change from baseline in SBP. Adverse events (AEs) were reported in 81.7%, 82.0% and 81.3% of patients on empagliflozin 10 mg, 25 mg and placebo, respectively. Confirmed hypoglycaemic AEs (glucose