Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose:: a randomised controlled trial
Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose:: a randomised controlled trial
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DOI：
10.1016/s0140-6736(06)69420-8
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发表时间：
2006-09-23
期刊：
影响因子：
168.9
通讯作者：
Ryden, L.
中科院分区：
文献类型：
--
作者：
Gerstein, H. C.;Yusuf, S.;Ryden, L.
背景罗格列酮是一种噻唑烷二酮类药物，可降低胰岛素抵抗并可能保护胰岛素分泌。本研究的目的是前瞻性地评估药物预防2型糖尿病高危人群的能力。方法从21个国家的191个研究中心招募了5269名年龄在30岁或30岁以上的空腹血糖受损或糖耐量受损，或两者兼而有之，既往无心血管疾病的成年人，并随机分配接受罗格列酮治疗（8毫克，每天; n=2365）或安慰剂（2634），并随访中位数为3年。主要结局是糖尿病事件或死亡的复合终点。该试验在ClinicalTrials.gov注册，编号NCT 00095654。结果在研究结束时，罗格列酮组有59人退出，安慰剂组有46人退出。罗格列酮组306例（11.6%）和安慰剂组686例（26.0%）患者出现复合主要结局（风险比0.40，95%CI 0.35-0.46; p
Background Rosiglitazone is a thiazolidinedione that reduces insulin resistance and might preserve insulin secretion. The aim of this study was to assess prospectively the drugs ability to prevent type 2 diabetes in individuals at high risk of developing the condition.Methods 5269 adults aged 30 years or more with impaired fasting glucose or impaired glucose tolerance, or both, and no previous cardiovascular disease were recruited from 191 sites in 21 countries and randomly assigned to receive rosiglitazone (8 mg daily; n=2365) or placebo (2634) and followed for a median of 3 years. The primary outcome was a composite of incident diabetes or death. Analyses were done by intention to treat. This trial is registered at ClinicalTrials.gov, number NCT00095654.Findings At the end of study, 59 individuals had dropped out from the rosiglitazone group and 46 from the placebo group. 306 (11.6%) individuals given rosiglitazone and 686 (26.0%) given placebo developed the composite primary outcome (hazard ratio 0.40, 95% CI 0.35-0.46; p