Novartis Pharmaceuticals Corporation Release: NAVIGATOR Data Presented At American Heart Association's Scientific Sessions Provide New Insights About Cardiovascular And Diabetes Risk
DALLAS, Nov. 16 /PRNewswire/ -- Data from more than 43,000 people screened for the landmark NAVIGATOR trial involving the anti-hypertension drug Diovan(R) (valsartan) have shown a high prevalence of multiple risk factors for cardiovascular and metabolic disease, often with an association of these diseases in individual patients.
A new analysis of the screening data presented at the American Heart Association's Scientific Sessions 2005 showed that patients with higher cardiovascular or metabolic risks had increasing levels of a marker called alanine aminotransferase, or ALT, for non-alcoholic fatty liver disease (NAFLD). An earlier analysis also showed that a high percentage of people with cardiovascular risk who were screened for the trial also had previously unrecognized type 2 diabetes or impaired glucose tolerance (IGT), which is also known as "pre-diabetes."
Of the people who completed the NAVIGATOR screening process, a total of 22 percent (n=9,092) had undiagnosed type 2 diabetes, while a further 28 percent (n=11,853) had unrecognized IGT, which can progress to type 2 diabetes. Type 2 diabetes and IGT are both risk factors for the development of cardiovascular disease.
"NAVIGATOR is one of the largest trials to examine interventions to simultaneously prevent diabetes and cardiovascular disease. The screening data provide an opportunity to understand the multiple intercorrelated risk factors present in people at high risk for both conditions," said Dr. M. Angelyn Bethel, Assistant Professor of Medicine at Duke University Medical Center. "Type 2 diabetes is associated with an increased risk of cardiovascular disease and mortality related to cardiovascular events. 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."
Results of NAVIGATOR, the first and largest study designed to understand the progression and prevention of diabetes and cardiovascular disease, are expected to be reported in 2008 and will further clarify treatment strategies for patients with IGT.
The new analysis found that risk factors comprising the metabolic syndrome, including high blood pressure, increasing body mass index (BMI), increasing waist circumference, and worsening glucose tolerance were independently associated with increasing levels of ALT. The term NAFLD defines a spectrum of liver abnormalities ranging from benign fatty liver (steatosis) to the more advanced condition known as non-alcoholic steatohepatitis. Recent
studies have demonstrated the link between insulin resistance in the liver and the subsequent development of NAFLD, which can progress to cirrhosis and end-stage liver disease.
More about NAVIGATOR and recent screening data
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.
NAVIGATOR, which is unique in its size and design, is a prospective, multinational, randomized, 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 have IGT and are 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.
More than 43,000 patients were screened for enrollment in the NAVIGATOR trial using a glucose tolerance test to assess their insulin sensitivity. Of the patients screened, 69 percent (n=28,556) were found to have hypertension, 42 percent (n=17,382) to have high levels of cholesterol, 28 percent (n=11,853) to have IGT and 22 percent (n=9,092) to have diabetes. Researchers found that 3.8 percent (n=1,546) had more than 1.5 times the normal upper limit of the liver enzyme ALT, a marker for NAFLD. A multivariate analysis showed risk factors for cardiovascular disease and metabolic syndrome were also associated with rising ALT levels. The associated risk factors included the following: increasing baseline systolic and diastolic blood pressure levels (p=0.03 and p=0.0001, respectively), increasing BMI (p<0.0001), waist circumference (p<0.0001), worsening glucose tolerance (both fasting and two hours post-challenge, p<0.0001) and metabolic syndrome (p<0.0001).
NAVIGATOR is one of the studies in the Diovan clinical trials program, which represents a large-scale research commitment across the cardiovascular continuum. Completed Diovan trials include VALUE in high blood pressure patients at high risk for cardiovascular events, VALIANT in post-heart attack patients and Val-HeFT in heart failure patients.
Diovan is indicated for the first-line treatment of hypertension and may be used over a dose range of 80 mg to 320 mg daily, administered once-daily. Diovan 80 mg and 160 mg are both approved starting doses for hypertension. Diovan 160 mg is recommended for patients requiring greater blood pressure reductions (if they are not volume-depleted).
Diovan should be discontinued as soon as pregnancy is detected because it may cause harm or even death to the unborn child.
Diovan is contraindicated for patients who are allergic to any of the ingredients of the product. Side effects in hypertension patients have generally been mild. The most common side effects with Diovan in hypertension patients are headache and dizziness. Volume and/or salt-depletion should be corrected in patients prior to administering Diovan or symptomatic hypotension may occur.
Starlix is indicated as monotherapy in patients with type 2 diabetes whose hyperglycemia cannot be adequately controlled with diet or exercise and who have not been chronically treated with other oral antidiabetic agents. In patients whose hyperglycemia is inadequately controlled with either metformin or after an initial therapeutic response to a thiazolidinedione, Starlix may be added to -- but not substituted for -- these drugs. Patients who have been chronically treated with a sufonylurea should not add or be switched to Starlix. As with any oral anti-diabetes medication, patients may experience side effects when taking Starlix. In studies, complications with Starlix included mild cold- or flu-like symptoms, dizziness, and joint ache. Low blood sugar levels occurred in 2.4 percent of patients taking Starlix.
Starlix should not be taken by patients with type 1 diabetes, diabetic ketoacidosis, or who are allergic to the drug in Starlix or its inactive ingredients. Starlix should be used with caution in patients with moderate to severe liver disease because such patients have not been studied.
For more information or full prescribing information for Diovan or Starlix go to "Prescribing Info/Quick Download" at http://www.pharma.us.novartis.com or call Maura Bergen at 862-778-4146 or Anna Frable at 862-778-5388.
The foregoing release contains forward-looking statements that can be identified by terminology such as "designed to understand," "to examine," "will further clarify," "delays or prevents," or by discussions regarding potential new indications or labelling for Diovan and/or Starlix, or regarding the long-term impact of a patient's use of Diovan and/or Starlix. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Diovan and/or Starlix to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Diovan and/or Starlix will be approved for any additional indications or labelling in any market. In particular, management's expectations regarding Diovan and/or Starlix could be affected by, among other things, additional analysis of Diovan and/or Starlix clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government pricing pressures, and other risks and factors referred to in the Company's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG and is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved net sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.1 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 91,700 people and operate in over 140 countries around the world.Novartis Pharmaceuticals. Inc.
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