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| |  Valsartan Slows Diabetes Progression, but Does Not Prevent Cardiovascular Events: Presented at ACC By Walter Alexander ATLANTA -- March 15, 2010 -- Valsartan, when added to a lifestyle modification program in patients at high risk for diabetes and cardiovascular disease, reduced progression to diabetes but not cardiovascular disease, according to results from the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) study. “Among persons with impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors, assignment to nateglinide for 5 years did not reduce the incidence of diabetes or the coprimary composite cardiovascular outcomes,” said Rury Holman, University of Oxford, Oxford, United Kingdom, on March 14 here at the 59th Annual Scientific Sessions of the American College of Cardiology (ACC) during a Late-Breaking presentation. “Lifestyle modification remains the best choice for preventing diabetes in high-risk patients,” he said. After mean follow-up of 5 years, the cumulative incidence of diabetes was 33% for the 1,531 patients receiving valsartan and 36.8% for the 1,722 patients receiving placebo (hazard ratio [HR] = 0.86; 95% confidence interval [CI], 0.80-0.92; P < .001). In addition, after a mean follow-up of 6.5 years, valsartan did not reduce the risk of composite cardiovascular outcomes (nonfatal myocardial infarction, nonfatal stroke, hospitalisation for heart failure, unstable angina, or the need for bypass surgery or catheter-based angioplasty). The second drug tested in NAVIGATOR, nateglinide, had no effect on progression to diabetes or cardiovascular disease. The lack of benefit, investigators speculated, may have been influenced by the effective lifestyle program’s low event rates or by the large number of patients receiving inhibitors of the rennin-angiotensin system, lipid-lowering agents, or antihypertensive agents. The international (40 countries), double-blind, NAVIGATOR trial included 9,306 patients with impaired glucose tolerance identified through a screening oral glucose tolerance test. Participants were aged 50 years and older and had known cardiovascular or at least 1 risk factor for cardiovascular disease. Patients were randomised in a 2x2 factorial design to nateglinide up to 60 mg TID before meals or placebo and valsartan up to 160 mg daily or placebo daily. In addition, they participated in a clinic- and telephone-based low-fat diet and exercise lifestyle intervention, with goals of 5% maintained weight loss and 30 minutes of exercise 5 days per week. David M. Nathan, MD, Harvard Medical School, Boston, Massachusetts, commented on the NAVIGATOR trial in a New England Journal of Medicine editorial: “The prevention of diabetes remains a critical public health priority, but for now we should steer away from these 2 drugs and use effective lifestyle interventions and, in selected persons, metformin to combat the epidemic.”(1) 1. Nathan DM, et al. [Published online ahead of print March 14, 2010.] NEJM. doi:10.1056/NEJMe1002322. [Presentation title: The Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR). Late-Breaking Clinical Trials I]
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