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Navigator study

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: a) development of diabetes b) 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 c) 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

General

clinical trial

References

  1. Califf RM for the NAVIGATOR Study Group Effect of Valsartan on the Incidence of Diabetes and Cardiovascular Events N Engl J Med. 2010 Mar 29 PMID: 20228403 http://content.nejm.org/cgi/content/full/NEJMoa1001121
  2. Holman RR for the NAVIGATOR Study Group Effect of Nateglinide on the Incidence of Diabetes and Cardiovascular Events N Engl J Med. 2010 Mar 29 PMID: 20228402 http://content.nejm.org/cgi/content/full/NEJMoa1001122