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首页> 外文期刊>Diabetes care >A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of topiramate controlled release in the treatment of obese type 2 diabetic patients.
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A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of topiramate controlled release in the treatment of obese type 2 diabetic patients.

机译：一项随机，双盲，安慰剂对照，多中心研究，评估托吡酯控释在肥胖2型糖尿病患者中的疗效和安全性。

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OBJECTIVE: This is a randomized, placebo-controlled study of the weight-loss efficacy and safety of a controlled-release (CR) formulation of topiramate in overweight and obese patients with type 2 diabetes treated with diet and exercise alone or in combination with metformin. RESEARCH DESIGN AND METHODS: Patients with type 2 diabetes, BMI > or =27 kg/m2, A1C >6.5 and <11.0%, treated with diet and exercise alone or in combination with metformin monotherapy were enrolled. Patients were randomized to placebo or topiramate CR titrated up to 175 mg/day. Treatment consisted of a 7-week titration phase followed by a 9-week maintenance phase. RESULTS: A total of 111 subjects were randomized and analyzed. By the end of week 16, patients in the placebo and topiramate groups lost 2.5 and 6.0 kg, which represented 2.3 and 5.8%, respectively, of their baseline body weight (P < 0.001 vs. placebo). A1C improved from a baseline of 7.4% in the placebo and 7.6% in the topiramate groups to 7.1 and 6.7%, respectively, representing a 0.4 and 0.9% reduction from baseline, respectively (P < 0.001 vs. placebo). Topiramate also significantly reduced blood pressure and urinary albumin excretion. Adverse events were predominantly neuropsychiatric or central and peripheral nervous system related. CONCLUSIONS: Topiramate CR treatment produced significant weight loss and meaningful improvements in A1C and blood pressure in obese patients with type 2 diabetes treated with diet and exercise or in combination with metformin. However, the central nervous system and psychiatric adverse event profile of topiramate CR makes it unsuitable for the treatment of obesity and diabetes.
机译：目的：这是一项托吡酯控释（CR）制剂在超重和肥胖的2型糖尿病患者中的减肥，疗效和安全性的随机，安慰剂对照研究，这些患者单独饮食和运动或与二甲双胍联合治疗。研究设计和方法：招募了2型糖尿病，BMI>或= 27 kg / m2，A1C> 6.5和<11.0％，单独饮食和运动或与二甲双胍联合治疗的患者。患者被随机分配至最高每天175 mg的安慰剂或托吡酯CR。治疗包括7周的滴定阶段和9周的维持阶段。结果：总共111名受试者被随机化和分析。到第16周结束时，安慰剂和托吡酯组的患者减掉了2.5千克和6.0千克，分别占其基线体重的2.3％和5.8％（与安慰剂相比，P <0.001）。 A1C从安慰剂组的7.4％和托吡酯组的7.6％的基线分别提高到7.1和6.7％，分别比基线降低0.4和0.9％（与安慰剂相比，P <0.001）。托吡酯还可以显着降低血压和尿白蛋白排泄。不良事件主要与神经精神病学或中枢和周围神经系统有关。结论：托吡酯CR治疗使肥胖的2型糖尿病患者通过饮食和运动或与二甲双胍联合治疗，可显着减轻体重，并改善A1C和血压。然而，托吡酯CR的中枢神经系统和精神病学不良事件特征使其不适用于肥胖症和糖尿病。

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