A key sign of vascular aging, arterial stiffness, reduced by leading blood pressure medication Diovan®

·         Arterial stiffness is a key marker of increased risk for stroke and heart attack

·         Arteries stiffen naturally with increasing age, but this is accelerated in patients with diabetes or high blood pressure

·         Study shows Diovan allows blood vessels to regain some of the elasticity they have lost

BASEL, Switzerland, September 19, 2007 — New data presented today demonstrate that Diovan® (valsartan) decreases arterial stiffness in people with type 2 diabetes and high blood pressure1.

The natural aging process makes all arteries stiffen over time, but in people with high blood pressure or diabetes this process is accelerated2. Patients with stiff arteries are at increased risk of stroke and heart attack3.

The study presented today at the European Association for the Study of Diabetes demonstrates that Diovan, an angiotensin receptor blocker (ARB) and the number one high blood pressure medication4, in combination with hydrochlorothiazide (HCT) reduces this stiffness1, allowing the vessels to regain some of the elasticity they have lost as a result of high blood pressure and diabetes. Diovan demonstrated significantly superior results compared to another type of high blood pressure medication, amlodipine, a calcium channel blocker1.

“People with high blood pressure and diabetes are at increased risk of heart and kidney disease and need the best possible protection” said Ameet Nathwani, MD, Global Head Cardiovascular Metabolism & Atherosclerosis, Clinical Development & Medical Affairs, Novartis Pharma AG. “These results further add to the wealth of data which show that in different patient populations Diovan not only lowers blood pressure effectively, but suggests additional protective benefits such as significant reductions in stroke5 and new onset diabetes6”.

The study compared the effect of a Diovan-based treatment (Diovan-HCT) with that of amlodipine on aortic pulse wave velocity (Ao-PWV – a measure of arterial stiffness) as well as albumin excretion rate (AER – a marker of kidney function) in 131 people with type 2 diabetes, high blood pressure and microalbuminuria over 24 weeks.

Both medications demonstrated similar reductions in systolic blood pressure, however the Diovan-based treatment demonstrated a significantly greater reduction in mean Ao-PWV compared to amlodipine (-1.1 m/s, p= 0.001) and AER fell by 35% compared to a rise of 24% in the amlodipine group (p=0.0004)1.

Dr Janaka Karalliedde, Kings College London, principle investigator of the study explains “the significantly greater reductions in arterial stiffness and albuminuria by Diovan are very exciting and warrant additional studies of specific cardiorenal protective effects.”

PWV describes how quickly a blood pressure pulse travels along an artery (measured in meters per second). A normal level is below 8m/s for a healthy person under 60 years old, but the stiffer the artery, the higher the PWV. An increase of 1m/s in Ao-PWV has been shown to equate to a 39% increase in risk of CV events2. Ao-PWV increases with age, rising by approximately 10-15% over 10 years7. Ao-PWV is also an independent marker of cardiovascular risk and mortality in people with high blood pressure8.

The benefits of Diovan have been demonstrated through the Diovan clinical trials program involving more than 100,000 patients. The megatrials VALUE, VALIANT, and Val-HEFT demonstrated effective blood pressure-lowering efficacy and cardioprotective benefits of Diovan in a range of different patient types9,10,11. The recently published DROP study also demonstrates that Diovan reduces urinary protein excretion in people with type 2 diabetes and high blood pressure12.

Diovan is available as a powerful first-line treatment for high blood pressure in more than 100 countries, for the treatment of people with heart failure in more than 90 countries, and for the treatment of heart attack survivors in more than 70 countries.

Disclaimer


The foregoing release contains forward-looking statements that can be identified by terminology such as “suggests”, “warrant”, or similar expressions, or by discussions regarding potential new indications or labelling for 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 be approved for any additional indications or labelling in any market. In particular, management’s expectations regarding Diovan could be affected by, among other things, unexpected clinical trial results, including new clinical data and additional analysis of existing 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; competition in general; increased government 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. 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.

About Novartis


Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ more than 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

References


1.        Karalliedde J et al. Blood pressure lowering-independent improvement of central arterial stiffness by valsartan, but not amlodipine, in type 2 diabetic patients with systolic hypertension. Poster at 43rd Annual meeting of the EASD, September 2007.


2.        Jani B, Rajkumar C. Ageing and vascular aging. Postgrad Med J 2006;82:357-62.


3.        Zoungas S, Asmar RP. Arterial stiffness and cardiovascular outcome. Clin Exp Pharmacol Physiol 2007;34:647-51. 


4.        IMS Sales Database April 2006 - March 2007.


5.        Mochizuki S et al. Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study. The Lancet 2007;369:1431-1439.


6.        Kjeldsen SE et al. Effects of valsartan compared to amlodipine on preventing type 2 diabetes in high-risk hypertensive patients: the VALUE trial. J Hypertens. 2006; 24: 1405-1412.


7.        Benetos A et al. Influence of age, risk factors, and cardiovascular and renal disease on arterial stiffness: clinical applications. Am J Hypertens 2002;15:1101-8.


8.        Safar ME et al. Aortic pulse wave velocity: an independent marker of cardiovascular risk. Am J Geriatr Cardiol 2002;11:295-8.


9.        Julius S et al. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet 2004; 363: 2022–31.


10.     Pfeffer MA et al. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N Engl J Med 2003; 349(20): 1893-906.


11.     Cohn J et al. A randomized trial of the angiotensin-receptor-blocker valsartan in chronic heart failure. N Engl J Med 2001; 345: 1667-1675.


12.     Hollenberg NK et al. Albuminuria response to very high-dose valsartan in type 2 diabetes mellitus. Journal of Hypertension 2007, 25:1921–6.

# # #

Novartis Media Relations


John Gilardi


Novartis Global Media Relations 


+41 61 324 3018 (direct)


+41 79 596 1408 (mobile)


john.gilardi@novartis.com  

 Vivienne Schneider


Novartis Pharma Communications


+41 61 324 6162 (direct)


+41 79 619 1335 (mobile)


vivienne.schneider@novartis.com

e-mail: media.relations@novartis.com

Posted: September 2007

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