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Novartis International AG

NAVIGATOR Trial Investigators Call for Closer Attention to Glucose Levels in Cardiovascular and Diabetes At-Risk Patients

Munich, Germany (ots/PRNewswire)

- Data from this and other Diovan(R)(valsartan) studies, including
VALIANT and Val-HeFT presented at the European Society Congress 2004
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 unrecognised 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 unrecognised 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(R) (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
[1] "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.

Contact:

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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