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Baseline characteristics of the Nateglinide and Valsartan Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial population: comparison with other diabetes prevention trials.

机译:那格列奈和缬沙坦糖耐量受损结果研究(NAVIGATOR)试验人群的基线特征:与其他糖尿病预防试验的比较。

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The Nateglinide and Valsartan Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial is exploring two pharmacological strategies (nateglinide and valsartan, both alone and in combination) in the prevention of overt diabetes mellitus (DM) and the reduction of cardiovascular disease (CVD) in subjects at high risk for these events. In this analysis, we provide baseline characteristics of the randomized NAVIGATOR study population and contrast them with those from other trials of DM prevention. Key eligibility criteria include impaired glucose tolerance (IGT) and impaired fasting glucose (IFG), a history of CVD (in patients aged > or =50 years), and > or =1 cardiovascular risk factor (in patients aged > or =55 years). Baseline demographic characteristics, laboratory findings, cardiovascular risk factors, CVD history, and medication use are described and compared with other trials of DM prevention. The full analysis set of subjects (N = 9306) showed a clustering of risk factors consistent with the metabolic syndrome: high rates of hypertension (77.5%), dyslipidemia (44.7%), increased waist circumference (101.0 cm), and high body mass index (BMI) (47.5% with BMI > or =30 kg/m(2)). A minority of patients had a history of CVD (24.3%); of these, 11.7% had a history of myocardial infarction and most of the remainder had evidence of coronary artery disease. Subjects also had elevated blood pressure (BP) (predominantly systolic) (139.7/82.6 mm Hg), increased serum low-density lipoproteins cholesterol levels (3.27 mmol/L), and borderline elevation of triglyceride levels (1.97 mmol/L). Demographic data, BP, and lipid profiles in NAVIGATOR were similar to those of previous DM prevention trials, which were also based largely on meeting criteria for IGT. Medication use at baseline among NAVIGATOR subjects, which frequently included aspirin, beta-blockers, calcium channel blockers, diuretics, and lipid-lowering agents, reflects enhanced CVD risk. However, little prescribing of renin-angiotensin-aldosterone system blockers was observed, likely due to protocol exclusion criteria. In conclusion, the NAVIGATOR study comprises prediabetic subjects who typically have concurrent BP and metabolic disturbances and an enhanced risk of CVD, and are thus at higher risk for cardiovascular events than subjects in previous DM prevention trials.
机译:那格列奈和缬沙坦糖耐量受损结果研究(NAVIGATOR)试验正在探索两种药理策略(那格列奈和缬沙坦,单独或联合使用),以预防受试者明显的糖尿病(DM)和减少心血管疾病(CVD)这些事件的风险很高。在此分析中,我们提供了随机NAVIGATOR研究人群的基线特征,并将其与其他DM预防试验的基线特征进行了对比。关键的资格标准包括葡萄糖耐量(IGT)受损和空腹血糖(IFG)受损,CVD病史(≥50岁的患者)和>或= 1心血管危险因素(≥55岁的患者) )。描述了基线人口统计学特征,实验室检查结果,心血管危险因素,CVD史和用药情况,并与其他DM预防试验进行了比较。整套分析对象(N = 9306)显示出与代谢综合征相符的危险因素聚集:高血压(77.5%),血脂异常(44.7%),腰围增加(101.0 cm)和高体重指数(BMI)(BMI>或= 30 kg / m(2)时为47.5%)。少数患者有CVD史(24.3%);其中,有11.7%的人有心肌梗塞病史,其余大多数有冠心病的证据。受试者的血压(BP)升高(主要为收缩压)(139.7 / 82.6 mm Hg),血清低密度脂蛋白胆固醇水平升高(3.27 mmol / L),甘油三酸酯水平升高(1.97 mmol / L)。 NAVIGATOR中的人口统计学数据,BP和脂质谱与先前的DM预防试验相似,这些试验也主要基于满足IGT的标准。在NAVIGATOR受试者中,基线时的药物使用通常包括阿司匹林,β受体阻滞剂,钙通道阻滞剂,利尿剂和降脂药,反映出CVD风险增加。但是,观察到几乎没有处方肾素-血管紧张素-醛固酮系统阻滞剂,这可能是由于方案排除标准所致。总之,NAVIGATOR研究包括糖尿病前期受试者,这些受试者通常同时发生BP和代谢紊乱,并增加CVD的风险,因此与先前的DM预防试验相比,其心血管事件的风险更高。

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