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Novartis Reports Preliminary Results Of Navigator Trial

Novartis has reported that results from a study involving more than 9,000 people showed that the high blood pressure medicine Valsartan delayed progression to type 2 diabetes in patients with cardiovascular disease or risk factors and impaired glucose tolerance (IGT).

Primary data from the Navigator (Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research) trial, initiated in 2001, were presented at the American College of Cardiology Annual Meeting in Atlanta, US and simultaneously published online in the New England Journal of Medicine.

Reportedly, the study assessed whether Valsartan or the oral anti-diabetic agent nateglinide could delay progression to diabetes or reduce the incidence of cardiovascular events in people with IGT and cardiovascular disease or risk factors.

Novartis said that Navigator was a prospective, multinational, randomised, double-blind, placebo-controlled, two-by-two factorial design trial being conducted in 39 countries at nearly 800 sites. The 9,306 patients enrolled in the trial had IGT and were either older than age 50 with diagnosed cardiovascular disease or older than age 55 with at least one risk factor for cardiovascular disease, such as high blood pressure, family history of heart disease, high cholesterol or smoking.

In addition to background therapy and a study-specific lifestyle modification program, patients were randomised to receive either Valsartan, nateglinide, Valsartan and nateglinide together, or placebo.

Navigator had three co-primary endpoints. The first endpoint was confirmed progression to overt diabetes, defined according to standard WHO/ADA criteria. The second (‘core’ cardiovascular) endpoint was a composite of time to first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for heart failure.

Whereas, the third (‘extended’ cardiovascular) endpoint consisted of the core cardiovascular endpoint plus revascularisation and hospitalisation for unstable angina. The median follow-up time (for vital status) was 6.5 years.

Patients in the study with IGT and cardiovascular disease or other risk factors, who received Valsartan for at least five years in addition to background therapy and a study-specific lifestyle-modification program, achieved 14% reduction in their risk of developing new-onset diabetes compared to those in the non-Valsartan group.

Rury Holman, professor of diabetic medicine at the oxford centre for diabetes for endocrinology and metabolism at University of Oxford, said: “Lifestyle modification remains the primary intervention for the prevention of diabetes. The NAVIGATOR study shows that Valsartan, when added to a lifestyle-modification program, can delay progression to diabetes in people who are at high cardiovascular risk and have impaired glucose tolerance.”

Novartis plans to discuss the results of this study with the FDA with a view to applying for a label change for Valsartan. Valsartan is currently indicated for the treatment of high blood pressure for the treatment of heart failure, and reducing the risk of cardiovascular mortality in patients who have suffered a heart attack (myocardial infarction). Nateglinide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Neither Valsartan nor nateglinide is currently indicated for the treatment of patients with IGT.