Navigator study

Introduction

Study characteristics:

• double-blind, randomized clinical trial
• 2-by-2 factorial design
• 9306 patients with impaired glucose tolerance & established cardiovascular disease or cardiovascular risk factors

Treatment groups:

• valsartan (up to 160 mg daily) or placebo (and nateglinide or placebo) in addition to lifestyle modification.
• patients followed for a median of 5.0 years for occurrence of 3 coprimary outcomes:
  • development of diabetes
  • an extended composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, arterial revascularization, or hospitalization for unstable angina
  • a core composite outcome that excluded unstable angina & revascularization

Results:

• valsartan modestly lowers the incidence of diabetes (14%), but not cardiovascular events
• nateglinide did not reduce the incidence of diabetes or cardiovascular complications

More general terms

• clinical trial