A total of 43,508 individuals were screened for the NAVIGATOR trial, which would compare treatment with the oral anti-diabetic nateglinide and the angiotensin receptor blocker valsartan for prevention of cardiovascular events and delay or prevention of type 2 diabetes.

Angelyn Bethel, MD, Assistant Professor of Medicine, Duke University Medical Center, Durham, North Carolina, United States, presented the findings on November 16th at the American Heart Association Scientific Sessions 2005 (AHA).

In her oral presentation, Dr. Bethel said that while conducting the oral glucose tolerance tests that were part of the screening, the researchers found that 9,092 individuals (20.9%) were already diabetic, but were unaware of their status. Another 11,853 individuals (27.2%) screened were found to have impaired glucose tolerance, a major step on the road to diabetes.

"Type 2 diabetes is associated with an increased risk of cardiovascular disease and mortality related to cardiovascular events" Dr. Bethel said. "As the incidence of type 2 diabetes continues to grow to epidemic proportions, it becomes more important that healthcare providers focus their efforts on interventions proven not only to improve diabetes control, but also to prevent the morbidity and mortality associated with cardiovascular disease."

The unique size of the NAVIGATOR cohort provided doctors with a chance to examine a large cohort of patients. "The screening data provide an opportunity to understand the multiple intercorrelated risk factors present in people at high risk for both conditions [diabetes and cardiovascular disease," Dr. Bethel said.

In addition to identifying more diabetics, the trialists also found that patients with higher cardiovascular or metabolic risks factors had increasing levels of alanine aminotransferase (ALT), a marker of non-alcoholic fatty liver disease.

NAVIGATOR is the first and largest study designed to understand the progression and prevention of diabetes and cardiovascular disease. The results are expected to be reported in 2008 and will further clarify treatment strategies for patients with impaired glucose tolerance, Dr. Bethel said. The ongoing NAVIGATOR (Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research) trial examines whether Diovan and/or Starlix(R) (nateglinide) delays or prevents the progression to type 2 diabetes and/or cardiovascular events. Diovan, a high blood pressure agent, is the most prescribed medication in the ARB (angiotensin receptor blocker) class in the US and worldwide. Starlix is indicated for the treatment of diabetes.

She said that the evidence provided so far show that risk factors comprising the metabolic syndrome -- high blood pressure, increasing body mass index, increasing waist circumference, and worsening glucose tolerance -- were independently associated with increasing levels of ALT, she said.

The interim data show that 3.8% of subjects had more than 1.5 times the upper limit of normal for the liver enzyme ALT.

Source: Diabetes In Control: [Presentation title: Association of Non-alcoholic Steatohepatitis (NASH) with Components of the Metabolic Syndrome in 43,509 Patients Screened for NAVIGATOR. Abstract 3822] The NAVIGATOR study is being sponsored by Novartis.