Empagliflozin as add-on to metformin in people with Type 2 diabetes
Empagliflozin as add-on to metformin in people with Type 2 diabetes
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DOI：
10.1111/dme.12814
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发表时间：
2015-12-01
影响因子：
3.5
通讯作者：
Broedl, U. C.
中科院分区：
文献类型：
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作者：
Merker, L.;Haering, H-U.;Broedl, U. C.
目的观察依帕利福与二甲双胍联合应用治疗2型糖尿病的远期疗效和安全性。方法637名受试者中，463名(72.7%)每天服用依帕利嗪10 mg、25 mg或安慰剂，共52周。结果与安慰剂组比较，糖化血红蛋白(1c)组的校正后平均变化(总体基线平均值+/-SD63+/-9 mm ol[7.9+/-0.9%])为-7 mm o l/m ol[(-0.6%)95%CI-8，-5 m o l/m ol(-0.8，-0.5%)；P<；10 mg和25 mg分别为-8 mmoL/m ol[(-0.7%)95%CI-10，-6 mmoL(-0.9，-0.6%)；P<；0.001]。与安慰剂相比，安慰剂10毫克和25毫克的调整后平均体重变化分别为-1.90公斤(95%可信区间-2.5，-1.3；P<；0.001)和-2.2公斤(95%可信区间-2.8，-1.6；P<；0.001)。与安慰剂相比，埃帕利福秦导致收缩压持续下降。77.7%的参与者报告了服用安慰剂的不良事件，80.2%的参与者报告了服用安慰剂的不良事件，80.2%的参与者报告了不良事件，72.0%的参与者报告了服用安慰剂的不良事件。确诊的低血糖不良事件(葡萄糖
Aims To investigate the long-term efficacy and safety of empagliflozin as add-on to metformin in people with Type 2 diabetes.Methods Of 637 participants treated with empagliflozin 10 mg, empagliflozin 25 mg, or placebo once daily for 24 weeks, 463 (72.7%) were treated in a double-blind extension trial for >= 52 weeks. Prespecified exploratory endpoints included changes from baseline in HbA(1c), weight and blood pressure at week 76.Results Compared with placebo, adjusted mean changes from baseline in HbA(1c) (overall baseline mean +/- SD 63 +/- 9 mmol/mol [7.9 +/- 0.9%]) were -7 mmol/mol [(-0.6%) 95% CI -8, -5 mmol/mol (-0.8, -0.5%); P < 0.001] and -8 mmol/mol [(-0.7%) 95% CI -10, -6 mmol/mol (-0.9, -0.6%); P < 0.001], for empagliflozin 10 mg and 25 mg, respectively. Compared with placebo, adjusted mean changes from baseline in weight were -1.9 kg (95% CI -2.5, -1.3; P < 0.001) and -2.2 kg (95% CI -2.8, -1.6; P < 0.001) for empagliflozin 10 mg and 25 mg, respectively. Empagliflozin led to sustained reductions in systolic blood pressure vs. placebo. Adverse events were reported in 77.7, 80.2 and 72.0% of participants on placebo, empagliflozin 10 mg and empagliflozin 25 mg, respectively. Confirmed hypoglycaemic adverse events (glucose