NAVIGATOR trial investigators call for closer attention to glucose levels in cardiovascular and diabetes at-risk patients

Main Category: Diabetes
Article Date: 31 Aug 2004 - 10:00 PST

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An analysis of more than 39,000 potential participants in the global NAVIGATOR (Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research) trial showed that an automatic assessment of glycemic status may improve unrecognized detection of type 2 diabetes and impaired glucose tolerance in people with heart disease or with risk factors for it.

Researchers found of those screened for the trial, one in four had undiagnosed type 2 diabetes, and a further 25-30 percent had previously unrecognized impaired glucose tolerance (IGT, also known as a pre-diabetes condition which frequently progresses to clinical diabetes). Type 2 diabetes and IGT are both risk factors for the development of cardiovascular disease.

"Physicians have long recognized cardiovascular disease as a common risk for people with both type 1 and type 2 diabetes; however, they are not aware of how frequently IGT and type 2 diabetes appear in people with heart disease or with risk factors for heart disease," said John McMurray, MD, Professor of Medical Cardiology, University of Glasgow, Scotland, UK and NAVIGATOR investigator.

"We're issuing this call for more vigilance on glycemic status. Although a high percentage of people we screened for NAVIGATOR tested positive for either IGT or type 2 diabetes, their previous medical records did not note these conditions," added Professor McMurray. "With nearly 800 sites in 39 countries, these findings suggest that this is not simply an issue in a few countries."

Commenting on the preliminary data from NAVIGATOR, Dr. Jörg Reinhardt, Head of Development, Novartis Pharma AG said, "Diovan has previously been associated with reducing new onset diabetes in a hypertensive high-risk population while Starlix has been proven to enhance early insulin secretion and reduce excessive post-meal blood glucose levels found in people with IGT and type 2 diabetes. Given the increasing prevalence of diabetes worldwide, the NAVIGATOR study takes on even greater importance in that it may demonstrate how these therapies can help millions of patients reduce their risk of developing clinical type 2 diabetes as well as cardiovascular disease. Novartis is pleased to be at the forefront of this pioneering research."

Though not expected to conclude until 2008, NAVIGATOR has already yielded data likely to prove useful to cardiologists and their patients. At its conclusion the trial will demonstrate whether the high blood pressure medicine Diovan or the oral anti-diabetic agent Starlix® (nateglinide) can reduce the incidence of CVD events and prevent people with IGT from progressing to clinical diabetes.

VALIANT study papers address critical issues for patients surviving heart attacks In addition to the news from NAVIGATOR, investigators from the VALIANT and Val-HeFT studies, also sponsored by Novartis, presented new data during the European Society of Cardiology Congress 2004:

· New findings by Dr. Scott D. Solomon, Director of the Noninvasive Cardiac Laboratory at Brigham and Women's Hospital and Associate Professor of Medicine at Harvard Medical School, Massachusetts, USA, and colleagues demonstrate that Diovan produces a positive effect on the size and function of the heart's left ventricle in people who have survived a myocardial infarction or MI. The positive effect was equivalent to that of the angiotensin converting enzyme (ACE) inhibitor drug captopril. · A sub-study led by Dr. Lars Kober, MD, Department of Cardiology, Gentofte University Hospital, Copenhagen, Denmark, notes that patients with a form of irregular heart rhythm known as atrial fibrillation (AF), which can show up before or after a heart attack, have increased risk of additional complications and death. According to a sub-study of the Val-HeFT trial presented by Professor Aldo Maggioni, GISSI Group, coordinated by the Italian Association of Hospital Cardiologists (ANMCO) and the Instituto di Ricerche Farmacologie, Mario Negri, Milan, Italy, Diovan demonstrated an ability to reduce AF.1 The new report poses the question of whether treatment can reduce AF in the post-MI population.

Novartis is focused on improving the care of patients with high blood pressure and heart disease through world-class research and unprecedented public health initiatives. The Diovan clinical trial program is one of the world's largest in cardiovascular research, involving approximately 50,000 patients including more than 9,500 patients with diabetes. Recently completed Diovan trials include VALUE in high blood pressure patients at risk for cardiovascular complications because of co-existing diseases or risk factors such as diabetes, history of stroke, and coronary artery disease; VALIANT in post-heart attack patients; and Val-HeFT in heart failure patients. Ongoing studies include the large outcomes NAVIGATOR trial and Val-MARC, a study on the effects of Diovan on C-reactive protein, an inflammatory marker for heart disease.

The fastest-growing high blood pressure drug on the market today, Diovan has been approved for first-line treatment of high blood pressure in more than 80 countries and in more than 50 for the treatment of heart failure in patients who also take usual therapy including diuretics, digitalis and either beta blockers or ACE inhibitors, but not both. In the U.S. and Switzerland, amongst other countries, Diovan is indicated for the treatment of heart failure in patients who cannot tolerate ACE inhibitors. On the basis of the results of VALIANT, Novartis has submitted marketing authorization applications to regulatory authorities around the world for a new indication for Diovan for use in patients at risk after having survived a heart attack. In addition to powerful double-digit blood pressure reductions and superior tolerability, patient persistency and patient compliance, Diovan has proven cardio-protective benefits beyond lowering blood pressure.

Starlix, a D-phenylalanine (amino acid) derivative, is a novel compound for the treatment of type 2 diabetes. Starlix was first approved in the U.S. in 2001 both as a monotherapy for drug-naïve patients with type 2 diabetes and also in combination with metformin, a leading oral antidiabetic agent. In 2003, the U.S. Food & Drug Administration approved the use of Starlix in combination with a thiazolidinedione (TZD) in patients with type 2 diabetes who are not adequately controlled after a therapeutic response to a TZD. Starlix is also approved in many countries around the world for the treatment of type 2 diabetes. In the EU, Starlix has been approved in combination therapy with metformin in type 2 diabetes patients inadequately controlled despite a maximally tolerated dose of metformin alone. Nateglinide is licensed to Novartis Pharma AG from Ajinomoto Co., Inc.

References

"Valsartan Reduces the Incidence of Atrial Fibrillation in the Patients with Heart Failure in the Val-HeFT trial." Abstract presented at ESC 2003.

About Novartis

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 80 000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "potential" "investigating", "new applications", or similar expressions, or by discussions regarding potential new indications or labeling for Diovan, Starlix, or regarding the long-term impact of a patient's use of either product. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Diovan 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 or Starlix will be approved for any additional indications or labeling in any market. In particular, management's ability to ensure satisfaction of the health authorities' further requirements is not guaranteed and management's expectations regarding commercialization of Diovan or Starlix could be affected by, among other things, additional analysis of Diovan 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; 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.

Contacts

John Gilardi
Novartis Global Media Relations
+41 61 324 3018 (direct)
+41 79 596 1408 (mobile)
john.gilardi@group.novartis.com

Karen Sutherland
Novartis Pharma Communications
+41 61 324 7143 (direct)
+41 79 593 1085 (mobile)
karen.sutherland@pharma.novartis.com

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