Affecting more than 400,000 Canadians, HF has a greater risk of death
than most cancers
DORVAL, QC, March 25 /CNW/ - Health Canada has approved a leading high
blood pressure medicine Diovan(*) (valsartan) to treat chronic heart failure
(HF) in patients who cannot tolerate angiotensin-converting-enzyme (ACE)
inhibitors, a common type of heart failure therapy.
Characterized by a progressive weakening of the heart muscle until it no
longer pumps blood effectively, HF is the most common cause for adult
hospitalizations in Canada(1) and carries a greater risk of death than most
"Quality of life remains compromised for many heart failure patients
since 20% to 50% of these individuals can not tolerate standard therapy," says
Dr. George Honos, a staff cardiologist and director of noninvasive cardiology
at the Sir Mortimer B Davis Jewish General Hospital in Montreal, Quebec. "The
approval of Diovan(*) is welcome news for this patient population who require
additional options to improve survival."
The approval is based on data from Val-HeFT (Valsartan Heart Failure
Trial), a study of 5,010 heart failure patients from 16 countries. Val-HeFT
demonstrated that Diovan significantly reduced combined all-cause mortality
(death) and morbidity (illness), a secondary endpoint in the study, in
patients with heart failure also taking usual therapy. However, the most
positive outcomes with Diovan(*) were largely seen in those patients who were
not taking an ACE inhibitor. In these patients, Diovan(*) improved survival by
41%, reduced morbidity by 49% and cut the risk for hospitalization for heart
failure by 57%.(3)
"Medications are only effective when taken by patients. The introduction
of Diovan(*) provides patients with an effective and tolerable option that will
not only assist with treatment adherence but will optimize their quality of
life," says Dr. Honos.
It is estimated that up to 400,000 Canadians are living with HF,(2) the
fastest growing disease in the world. As a result of the heart's right or left
chambers failing, blood backs up into or "congests" different areas of the
body including the liver, abdomen, lower extremities and lungs. This back-up
of blood in different areas of the body often leads to various symptoms which
may include swollen ankles, loss of energy, pale skin, sudden weight gain, and
HF can be caused by a number of cardiovascular conditions including long
standing high blood pressure, a faulty heart valve, an infection of the heart
muscle, a heart attack, and diabetes.(5) Over five years, 40% to 50% of
patients may die.(2)
The chronic disease develops slowly, often over years, as the heart
gradually loses its pumping ability and works less efficiently, eventually
leading to death. While patients can make changes to their diet and physical
activity, they will nevertheless require sustained drug treatment to improve
the symptoms and outcomes associated with this condition.
"Physicians know Diovan(*) as a trusted and effective medicine to control
blood pressure and reduce cardiovascular mortality," says Dr. Jean-Marie
Leclerc, Chief Scientific Officer and Senior Vice-President, Clinical and
Regulatory Affairs at Novartis Pharmaceuticals Canada Inc. "This important new
indication reflects our intensive clinical development program for Diovan(*)
over the last ten years to help patients across the continuum of
cardiovascular disease." Diovan(*) is supported by one of the world's largest
and most innovative clinical trial programs with an ARB involving over 50,000
patients including over 8,000 with diabetes.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "can offer" or similar expressions, or by
express or implied discussions regarding potential new indications or
labelling for Diovan(*), or regarding potential future sales of this product.
Such forward-looking statements involve known and unknown risks, uncertainties
and other factors that may cause actual results with Diovan(*) to be materially
different from any future results, performance or achievements expressed or
implied by such statements. There can be no guarantee that Diovan(*) will be
approved for any additional indications or labelling in any other market. Nor
can there be any guarantee regarding potential future sales of Diovan(*). In
particular, management's expectations regarding these products could be
affected by, among other things, competition in general; industry, government,
and general public pricing pressures; unexpected clinical trial results,
including additional analysis of existing clinical data, and new clinical
data; unexpected regulatory actions or delays or government regulation
generally; the company's ability to obtain or maintain patent or other
proprietary intellectual property protection; and other risks and factors
referred to in Novartis AG'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,
About Novartis Canada
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field,
is committed to the discovery, development and marketing of innovative
products to improve the well-being of all Canadians. Novartis Pharmaceuticals
Canada Inc. conducts hundreds of clinical trials across the country seeking
new treatments for cardiovascular disease, oncology, diabetes, cancer,
ophthalmology and organ transplantation. In 2007, the Company invested close
to $86 million in research and development. Novartis Pharmaceuticals Canada
Inc. employs more than 800 people in Canada and its headquarters are located
in Dorval, Québec. In addition to Novartis Pharmaceuticals Canada Inc., the
Novartis Group in Canada consists of Novartis Animal Health Canada Inc.,
Novartis Consumer Health Canada Inc., CIBA Vision Canada Inc. and Sandoz
Canada Inc. For further information about Novartis Canada, please consult
Novartis AG provides healthcare solutions that address the evolving needs
of patients and societies. Focused solely on growth areas in healthcare,
Novartis offers a diversified portfolio to best meet these needs: innovative
medicines, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, and consumer health products. Novartis is the only company
with leading positions in these areas. In 2007, the Group's continuing
operations (excluding divestments in 2007) achieved net sales of
USD 38.1 billion and net income of USD 6.5 billion. Approximately
USD 6.4 billion was invested in R&D activities throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 98,200 full-time associates and operate in over 140 countries
around the world. For more information, please visit www.novartis.com.
(*)Diovan is a registered trademark.
1. Zdeb, C. Heart Failure: a success story; Preventative care allows
patients to live decades longer than in the past. The Edmonton
Journal. February 18, 2008. Section D,1.
2. Is failing health care linked to failing hearts? Canadian
Cardiovascular Society. Available at:
Accessed February 28, 2008.
3. Maggioni A, Anand I, Gottlieb S, Latini R, Tognoni G, Cohn J. Effects
of valsartan on morbidity and mortality in patients with heart
failure not receiving ACE inhibitors. J Am Coll Cardiol 2002;40;
4. Heart Failure. CNN.com Available at:
February, 29, 2008.
5. What is Congestive Heart Failure? The Heart and Stroke Foundation.
Accessed February, 28, 2008.
For further information:
For further information: Media Contacts: For additional information
about this news release or to arrange an interview with a physician, please
contact: Melissa Maloul, Cohn & Wolfe, (514) 845-2257, ext. 228,
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