Baseline Characteristics of the Nateglinide and Valsartan Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) Trial Population: Comparison with Other Diabetes Prevention Trials

Krum, H., McMurray, J. J. V. , Horton, E., Gerlock, T., Holzhauer, B., Zuurman, L., Haffner, S. M., Bethel, M. A., Holman, R. R. and Califf, R. M. (2010) Baseline Characteristics of the Nateglinide and Valsartan Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) Trial Population: Comparison with Other Diabetes Prevention Trials. Cardiovascular Therapeutics, 28(2), pp. 124-132. (doi:10.1111/j.1755-5922.2010.00146.x)

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Abstract

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 >= 50 years), and >= 1 cardiovascular risk factor (in patients aged >= 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 >= 30 kg/m2). 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

Item Type:Articles
Keywords:aged ASPIRIN ASSOCIATION BLOOD blood pressure BLOOD-PRESSURE BMI CARDIOVASCULAR EVENTS cardiovascular risk CARDIOVASCULAR-DISEASE CARE CORONARY-ARTERY-DISEASE diabetes DIAGNOSIS DISEASE DISTURBANCES EVENTS HIGH-RISK hypertension IMPAIRED FASTING GLUCOSE Impaired glucose tolerance INFARCTION LEVEL LIFE-STYLE LIPID PROFILES LOW-DENSITY-LIPOPROTEIN MELLITUS METABOLIC SYNDROME Myocardial infarction MYOCARDIAL-INFARCTION Nateglinide outcome OUTCOMES pharmacology POPULATION PREVENTION RATIONALE REDUCTION REFLECTS RISK risk factors RISK-FACTOR RISK-FACTORS SCIENTIFIC STATEMENT SERUM TRIAL TYPE-2 Valsartan
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McMurray, Professor John
Authors: Krum, H., McMurray, J. J. V., Horton, E., Gerlock, T., Holzhauer, B., Zuurman, L., Haffner, S. M., Bethel, M. A., Holman, R. R., and Califf, R. M.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences
Journal Name:Cardiovascular Therapeutics
ISSN:1755-5914

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