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Effect of Valsartan on the Incidence of Diabetes and Cardiovascular Events
The NAVIGATOR Study Group*
A bs t rac t
It is not known whether drugs that block the renin–angiotensin system reduce the risk of diabetes and cardiovascular events in patients with impaired glucose tolerance.
MethodsThe authors are listed in the Appendix. Address reprint requests to Dr. Robert M. Califf at the Duke Translational Medi cine Institute, P.O. Box 17969, Durham, NC 27715, or at email@example.com.*The names of the investigators and members of the committees in the Na teglinide and Valsartan in Impaired Glu cose Tolerance Outcomes Research (NAVIGATOR) Study Group are listed in SupplementaryAppendix 1, available with the full text of this article at NEJM.org. This article (10.1056/NEJMoa1001121) was published on March 14, 2010, at NEJM .org. N Engl J Med 2010.
Copyright © 2010Massachusetts Medical Society.
In this double-blind, randomized clinical trial with a 2-by-2 factorial design, we assigned 9306 patients with impaired glucose tolerance and established cardiovasculardisease or cardiovascular risk factors to receive valsartan (up to 160 mg daily) or placebo (and nateglinide or placebo) in addition to lifestyle modification. We then followed the patients for a median of5.0 years for the development of diabetes (6.5 years for vital status). We studied the effects of valsartan on the occurrence of three coprimary outcomes: the development of diabetes; an extendedcomposite outcome of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, arterial revascularization, or hospitalization for unstableangina; and a core composite outcome that excluded unstable angina and revascularization.
The cumulative incidence of diabetes was 33.1% in the valsartan group, as compared with 36.8% in the...