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Intensive and standard glucose control did not differ for major CV events or death in poorly controlled type 2 diabetes

机译:在控制不佳的2型糖尿病中,主要的心血管事件或死亡的强化和标准血糖控制无差异

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In patients with poorly controlled type 2 diabetes, how does intensive glucose control compare with standard control for reducing cardiovascular (CV) events? nnMethodsnnDesign: Randomized controlled trial (Veterans Affairs Diabetes Trial [VADT]). ClinicalTrials.gov NCT00032487.nnAllocation: Unclear allocation concealment.*nnBlinding: Blinded (outcome assessors).*nnFollow-up period: Median 5.6 years.nnSetting: 20 sites in the USA.nnPatients: 1791 patients (mean age 60 y, 97% men) who had inadequate responses to maximum doses of an oral agent or insulin therapy. Exclusion criteria included glycated hemoglobin (Hb) level < 7.5%, CV event in the past 6 months, advanced congestive heart failure (CHF), severe angina, body mass index (BMI) > 40 kg/m2, serum creatinine level > 1.6 mg/dL (141 µmol/L), and alanine aminotransferase level > 3 times the upper normal limit.nnIntervention: Intensive (n = 892) or standard glucose control (n = 899). Patients were given oral metformin plus rosiglitazone (BMI 27 kg/m2) or oral glimepiride plus rosiglitazone (BMI < 27 kg/m2). The intensive-control group started with maximum doses, and the standard-control group started with half-maximum doses. Patients in the intensive-control group who did not achieve glycated Hb levels < 6% and patients in the standard-control group who did not achieve levels < 9% were started on insulin. The goal of intensive control was absolute reduction in glycated Hb levels by 1.5% compared with standard control.nnOutcomes: First major CV event (composite endpoint of myocardial infarction [MI], stroke, CV death, CHF, surgery for vascular disease, inoperable coronary disease, and amputation for ischemic gangrene). Secondary outcomes included all-cause mortality and microvascular complications.nnPatient follow-up: 86% (intention-to-treat analysis).
机译:在2型糖尿病控制不佳的患者中,强化血糖控制与标准控制相比如何减少心血管事件(CV)? nnMethodsnnDesign:随机对照试验(退伍军人事务糖尿病试验[VADT])。 ClinicalTrials.gov NCT00032487.nn分配:分配隐藏不明确。* nn盲:盲人(结果评估者)。* nn随访时间:中位5.6年。nn设置:在美国20个地点。nn患者:1791名患者(平均年龄60岁,97%)男性)对最大剂量的口服药物或胰岛素治疗反应不佳。排除标准包括糖化血红蛋白(Hb)水平<7.5%,过去6个月的CV事件,晚期充血性心力衰竭(CHF),严重心绞痛,体重指数(BMI)> 40 kg / m2,血清肌酐水平> 1.6 mg / dL(141 µmol / L),丙氨酸转氨酶水平>正常上限的三倍。nn干预:强化(n = 892)或标准葡萄糖对照(n = 899)。患者口服二甲双胍加罗格列酮(BMI 27 kg / m2)或口服格列美脲加罗格列酮(BMI <27 kg / m2)。强化对照组从最大剂量开始,标准对照组从最大剂量的一半开始。强化对照组中未达到糖化Hb水平<6%的患者和标准对照组中未达到糖化Hb水平<9%的患者开始接受胰岛素治疗。强化控制的目标是与标准控制相比,糖化血红蛋白水平绝对降低1.5%。nn结果:首次重大CV事件(心肌梗死[MI]的综合终点,中风,CV死亡,CHF,血管疾病手术,无法手术的冠状动脉疾病)疾病和缺血性坏疽的截肢术)。次要结果包括全因死亡率和微血管并发症。nn患者随访率:86%(意向性治疗分析)。

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  • 来源
    《ACP Journal Club》 |2009年第3期|p.8-8|共1页
  • 作者

    Gillian L. Booth MD MSc;

  • 作者单位

    Michael's Hospital, University of TorontoToronto, Ontario, Canada;

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  • 正文语种 eng
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