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Diovan (valsartan) significantly reduces risk of restenosis in patients after stent implantation

Val-PREST Study provides further evidence of Diovan's protective
effects in cardiovascular disease
Basel, London (ots-PRNewswire)- New research, presented at the 4th
International Symposium on Angiotensin II Antagonism in London, shows
that the highly selective angiotensin receptor blocker (ARB) Diovan
(valsartan) significantly reduces the risk of restenosis in patients
after stent implantation by 50% (p(0.005), and the need for
re-intervention by 58% (p(0.005) in patients with coronary artery
disease.1 This is the first demonstration of a positive effect by
systemic pharmacological intervention on restenosis rate after stent
implantation.
Dr Stefan Peters, lead investigator for Val-PREST2 (Valsartan for
Prevention of Restenosis After Stenting of Type B2/C Lesions*) at the
Dorothea Christiane Hospital, Erxleben, Quedlimburg, Germany,
comments, "Restenosis (narrowing of a coronary artery that has been
previously widened) remains a major limitation of balloon angioplasty
and stenting procedures. This finding is important as the practical
benefits for patients may include a reduced risk of myocardial
infaction, reduction in the need for hospitalisation for further
invasive stenting procedures, and improvements in quality of life."
Val-PREST was a randomised, open-labelled, single-centre clinical
trial involving 200 patients with coronary artery disease requiring
coronary intervention.2 Over a six-month treatment period, 99
patients received 80mg Diovan daily and 101 received open treatment
(including beta blocker and/or ACE inhibitor); patients in both
groups also received 100mg aspirin and 250mg td ticlopidine for four
weeks. Administration of Diovan 80mg led to a significant (p(0.005)
reduction in the risk of restenosis: 20% of patients in the Diovan
group experienced restenosis, compared to 40% in the open treatment
group. Re-intervention was 12% in the Diovan group compared to 29% in
the open treatment group.
Diovan prevents the detrimental effects of angiotensin II at the
AT1 receptor while preserving the beneficial effects through the
unblocked AT2 receptor. Angiotensin II plays an important role in
endothelial function. The endothelium (the single layer of flattened
cells lining blood vessels) is crucial in the regulation of vascular
tone, growth and structure. After arterial injury due to stenting,
Diovan, by selectively blocking the AT1 receptor, may reduce vascular
smooth muscle cell migration and proliferation within the endothelium
and may consequently reduce in-stent restenosis.
The results of Val-PREST add to the growing body of evidence that
confirms the highly protective effect of Diovan across a variety of
cardiovascular diseases. The recently presented landmark Val-HeFT
study has already demonstrated cardio-protective benefits with Diovan
in patients with heart failure, through proven reduced combined
all-cause mortality and morbidity in patients also taking usual
therapy. Diovan is now the only angiotensin II receptor blocker (ARB)
to demonstrate this benefit in a large-scale trial in patients with
heart failure.3 Diovan has also been shown to confer renal protection
through reduced microalbuminuria,4 as well as demonstrating benefits
through reduction of left ventricular dysfunction.5
In addition to these studies, Novartis is conducting three other
major international trials to support the Diovan promise of
prolonging and improving patients' lives across a variety of
cardiovascular disease states by enrolling 35,000 patients in the
largest clinical trial programme of any AT1 receptor blocking agent.
VALIANT (post-myocardial infarction patients); VALUE (high-risk
patients with hypertension); and ABCD-2V (involving adult type-2
diabetes patients with either normal or high blood pressure).
Diovan is a well-established, highly selective angiotensin
receptor blocker (ARB) and is recommended by the World Health
Organisation (WHO) for first-line treatment of hypertension. Over
three million patients world-wide currently take Diovan. Approved in
more than 80 countries, Diovan is the fastest growing branded
prescription antihypertensive in several markets including the US.
Diovan achieved sales of 1.2 billion CHF in 2000. Novartis is to seek
world-wide approvals for Diovan in the treatment of heart failure
based on the positive findings of Val-HeFT.
This press release contains forward looking statements which can
be identified by the use of forward looking terminology such as "may
include a reduced risk", "prevents", "may reduce", "conducting",
"promise", "growing" or similar expressions. Such forward looking
statements involve known and unknown risks, uncertainties and other
factors that may cause actual results to be materially different from
any future results, performance or achievements expressed or implied
by such statements. There are no guarantees that the aforementioned
clinical trials will result in the commercialisation of any product
in any market. Any such commercialisation can be affected by, amongst
other things, uncertainties relating to product development,
regulatory actions or delays or government regulation generally, the
ability to obtain or maintain patent or other proprietary
intellectual property protection and competition in general. Any of
these and other factors can cause the actual results to differ
materially from the expected or predicted results.
Novartis (NYSE: NVS) is a world leader in healthcare with core
businesses in pharmaceuticals, consumer health, generics, eye-care,
and animal health. In 2000, the Group's ongoing businesses achieved
sales of CHF 29.1 billion (USD 17.2 billion) and invested
approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Headquartered
in Basel, Switzerland, Novartis employs about 67 600 people and
operates in over 140 countries around the world. For further
information please consult http://www.novartis.com.
*B2/C lesions as defined by the ACC/AHA classification are
atherosclerotic lesions on the blood vessel wall that are of a
complex nature (many factors determine the complexity of the lesions,
e.g., if formed at an artery branch). These lesions often require
surgical intervention through angioplasty to widen the narrowed
artery.
References
1 Data presented at the 4th Angiotensin II Antagonism meeting,
London, 3-5 April, 2001
2 Peters, S. Valsartan for prevention of restenosis after stenting
of type B2/C lesions: the Val-PREST trial, Journal of Invasive
Cardiology 2000;13(12):93-97
3 Data presented at the 73rd Scientific Sessions of the American
Heart Association, New Orleans, 12-15 November, 2000
4 Muirhead N, et al. Valsartan (Diovan): effect on
microalbuminuria in patients with type II diabetes and nephropathy. J
Am Coll Cardiol 1999;33(Suppl A):299A.Abstract 872-5
5 Thurmann PA, et al. Influence of the angiotensin II antagonist
valsartan on left ventricular hypertrophy in patients with essential
hypertension. Circulation 1998;98:2037-42
General information about hypertension and Diovan is available at
http://www.hypertensionandhealth.com

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