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Novartis: Diovan + Diuretic Reduces Artery Ageing June, 2008





Swiss drugmaker Novartis AG (NVS) said Thursday that a study published in the latest issue of Hypertension demonstrates that the leading angiotensin receptor blocker Diovan in combination with the diuretic hydrochlorothiazide reduces artery stiffness, a sign of artery ageing, in patients with type 2 diabetes, high blood pressure and kidney disease compared to those taking another widely-used high blood pressure medicine, amlodipine.

Diovan/HCT demonstrated significantly superior benefits on artery elasticity compared to amlodipine, even though both treatment regimens had a similar effect in reducing blood pressure1. This is the first report of an improvement in artery elasticity with an ARB in this patient population.

The ageing process is associated with a gradual loss of elasticity in the arteries, but this is prematurely accelerated in people with diabetes and/or high blood pressure. Patients with less elastic arteries are at increased risk of stroke and heart attack

The study demonstrated that Diovan/HCT, the number one branded high blood pressure medication, improved the elasticity of arteries in people with high blood pressure, type 2 diabetes and kidney disease.

"Diabetes creates a potentially dangerous loss of elasticity in the arteries in addition to the natural ageing process," said Dr. Janaka Karalliedde of King's College London, the principal investigator of the study. "People with diabetes have an arterial age around 10 years older than those without, putting them at increased risk of death from heart disease or stroke. That is why the benefit of Diovan/HCT on artery elasticity in these patients is particularly important."

The measure of artery elasticity used in this study (aortic pulse wave velocity, abbreviated here as PWV) is a strong predictor of increased risk of stroke and heart attack in people with high blood pressure, type 2 diabetes and kidney disease(1,2). PWV measures how quickly a blood pressure pulse travels along an artery - the stiffer the artery, the higher the PWV - and is an independent marker of cardiovascular risk and mortality in people with high blood pressure.

The 24-week study compared the effect of a Diovan-based treatment (Diovan with the addition of HCT after four weeks) with that of amlodipine (up-titrated after four weeks) on PWV in 131 people with type 2 diabetes, high blood pressure and a marker of kidney disease called microalbuminuria(1).

Both Diovan/HCT and amlodipine demonstrated similar reductions in systolic blood pressure, but Diovan/HCT demonstrated a significantly greater reduction in average PWV compared to amlodipine (-1.1 meters per second, p=0.001)(1). Systolic blood pressure, measured when the heart contracts and pumps, is the most important indicator of a person's risk of cardiovascular events.

"These results demonstrate that Diovan/HCT improves artery elasticity to a greater extent than the widely used high blood pressure medicine amlodipine in these high-risk patients, adding to the spectrum of protective benefits provided by Diovan-based therapies," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "We continue to show the efficacy of Diovan over and above blood pressure lowering alone, offering patients a real benefit for improved artery health."

The study also compared Diovan/HCT with amlodipine on albumin excretion rate (AER), a key marker of kidney disease. In the Diovan/HCT group the AER fell by 35% compared to a rise of 24% in the amlodipine group (p=0.0004)(1), building on previous results demonstrating Diovan's potential kidney-protective effects. These include the MARVAL study in which Diovan lowered AER more effectively than amlodipine in patients with type 2 diabetes and microalbuminuria and the DROP study demonstrating that Diovan reduced urinary albumin excretion in people with type 2 diabetes and high blood pressure.

The benefits of Diovan have been demonstrated through its clinical trials program involving more than 100,000 patients. The large outcome trials VALUE, VALIANT, and Val-HEFT demonstrated effective blood pressure lowering and cardioprotective benefits of Diovan in a range of different patient types.

Diovan is available as a powerful 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.

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