- New treatment approved to reduce cardiovascular death in those at high risk
Toronto, Ontario, September 21, 2005 - Novartis
Pharmaceuticals Canada Inc. announced today that Health Canada has
approved PrDiovan® (valsartan) for a new
indication to reduce cardiovascular death in patients at high risk
(with heart failure or left ventricular dysfunction) following a
heart attack. Diovan® is the world's most prescribed
angiotensin-receptor blocker (ARB) for mild-to-moderate
hypertension.
Currently, one in three patients who survives a heart attack will
die within one year.1"Medications like valsartan are an
important tool in our therapeutic strategy to reduce morbidity and
mortality in this patient group who often can't or won't take their
medications due to side effects," said Kenneth R. Melvin, MD, FRCPC,
a Toronto cardiologist.
"Valsartan is proven to be more tolerable than some of the first
line therapies used to treat heart attack survivors, so while
offering excellent blood pressure control it supports better
compliance," continued Dr. Melvin.
High blood pressure, a disease which affects about one in five
Canadians2, greatly increases the risk of suffering a
heart attack, as does smoking, obesity, high cholesterol and
diabetes. There are 70,000 heart attacks in Canada each
year2, and these patients are at greater risk of repeat
attacks or death. In fact, approximately half of all heart attacks
are repeat attacks.1
Heart attack survival
Within six years after a heart
attack:
- 1 in 15 will die suddenly
- 1 in 12 men and 1 in 9 women will have a stroke
- 1 in 5 men and 2 in 5 women will be disabled by heart failure
(progressive heart disease)
- 4 in 10 people who suffer a heart attack develop heart failure
- People who develop these complications are four times more
likely to die.1
Every 7 minutes someone in Canada suffers a heart
attack3
"While we've made great strides in terms
of saving people when they have their first heart attack, death due
to a second event remains too high," said Jean-Lucien Rouleau, MD,
FRCPC, of the Montreal Heart Institute, dean of the Université de
Montréal Faculty of Medicine, and a lead investigator of VALIANT
(VALsartan In Acute myocardial
iNfarcTion), the study that led to Health Canada's
approval. "VALIANT was a tremendous scientific undertaking involving
more than 14,000 patients in 24 countries including over 1,000
Canadians at 67 centres coast-to-coast.3 We are proud it
has resulted in the approval of a new treatment to reduce
cardiovascular death following a heart attack."
New approval based on landmark VALIANT
trial4
The Health Canada approval of
Diovan® to reduce cardiovascular death in high-risk heart
attack survivors is based on the results of VALIANT, one of the
largest, long-term studies ever conducted in people who have
suffered a heart attack. VALIANT was a rigorous comparison of
Diovan® vs. captopril, an angiotensin converting enzyme
(ACE) inhibitor, vs. the combination of both in 14,703 patients at
high risk for death following a heart attack. In the VALIANT trial
Diovan® was reported to improve survival and reduce
cardiovascular events including recurrent heart attack and
hospitalizations for heart failure in these patients.
There
were no differences observed in overall mortality among the
treatment groups. The results of VALIANT were published in the
peer-reviewed journal, the New England Journal of Medicine,
and presented at the American Heart Association Scientific Sessions
in November, 2003.
A demonstrated commitment to improving patient
care
Novartis Pharma AG 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 represents an
impressive research commitment across the cardiovascular continuum,
which involves more than 55,000 patients. Recently completed
Diovan® trials include VALUE in high blood pressure
patients; VALIANT in post-heart attack patients; and Val-HeFT in
heart failure patients. Ongoing studies include the NAVIGATOR trial,
examining whether long-term treatment with Diovan® delays
or prevents the progression to type 2 diabetes and/or cardiovascular
events in 9,524 people with impaired glucose tolerance, and
Val-MARC, a study of the effects of Diovan® on C-reactive
protein, an inflammatory marker for heart disease.
About Diovan®
The most prescribed ARB
(angiotensin receptor blocker) in world5,
Diovan® is indicated for the first-line treatment of
mild-to-moderate essential hypertension and may be used over a dose
range of 80 mg to 160 mg daily, administered once-a-day.
In
clinically stable patients with signs or symptoms of left
ventricular dysfunction in conjunction with acute myocardial
infarction when the use of an angiotensin-converting enzyme
inhibitor (ACEI) is not appropriate, Diovan® is indicated
to reduce cardiovascular mortality. The recommended starting dose
for post-MI therapy is 20 mg twice daily (1/2 40 mg scored tablet)
initiated as early as 12 hours after a myocardial infarction,
followed by up titration within 7 days to 40 mg twice daily, with
subsequent titrations to a target maintenance dose of 160 mg twice
daily, as tolerated by the patient. If symptomatic hypotension or
renal dysfunction occurs, consideration should be given to a dosage
reduction. Diovan® should be given with other standard
post-myocardial infarction treatment, including thrombolytics,
aspirin and statins, as indicated.
Forward looking statement
The foregoing release
contains forward-looking statements that can be identified by
terminology such as "significant," "added benefit," "tremendous," or
similar expressions, or by express or implied discussions regarding
potential additional marketing approvals or future sales of
Diovan®. 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 receive any additional marketing approvals
in any other countries, or that it will reach any particular sales
levels. In particular, management's expectations regarding
commercialization of Diovan® could be affected by, among
other things, additional analysis of Diovan® 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, industry, and general public 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. The purpose of this media document is for
information only, and is not meant to promote or encourage a use of
this medication outside the approved Product Monograph in Canada.
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.
