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MARVAL Study Finds Diovan(R) Effective in Reducing Microalbuminuria, an Early Sign of Diabetic Kidney Disease.


/ADVANCE/SAN FRANCISCO, May 17 /PRNewswire/ --

New research shows the angiotensin II receptor blocker (ARB), Diovan(R) (valsartan), is more effective in reducing microalbuminuria (p<0.001), an early sign of diabetic kidney disease, compared to the calcium channel blocker, amlodipine. As part of the study, both treatment groups had blood pressure controlled to the same level. The results of the Microalbuminuria Reduction with Valsartan (MARVAL) trial were presented today at the 16th Annual Scientific Session of the American Society of Hypertension (ASH) in San Francisco. Diovan is well established as first-line treatment for hypertension and is marketed by Novartis Pharmaceuticals Corporation.

Microalbuminuria is an early sign of diabetic kidney disease (nephropathy) and occurs when kidneys deteriorate and leak protein into the urine. Left untreated, microalbuminuria may progress to end-stage renal disease (ESRD), resulting in the need for dialysis or transplantation. Up to 40% of people with type 2 diabetes (non-insulin dependent) develop ESRD and the annual cost of treating ESRD in the US is $14.5 billion. High blood pressure contributes to microalbuminuria and subsequent kidney failure and is the second most common cause of ESRD, as well as a leading risk factor for heart attack, heart failure, and other heart disease. About 60 to 65 percent of people with diabetes have hypertension.

MARVAL was a multi-center, double-blind, randomized, parallel study of 332 type 2 diabetes patients aged 35-75 with microalbuminuria with normal or high blood pressure. Patients were randomized to receive valsartan 80 mg once-daily or amlodipine 5 mg once-daily over 24 weeks. A target blood pressure of 135/85 mm/Hg was aimed for by dose doubling and the addition of bendrofluazide (a thiazide diuretic) and doxazosin (an alpha blocker) therapy. The study was designed to assess the blood-pressure-independent effects of Diovan vs. amlodipine on urinary albumin excretion rates (UAER), a measure of microalbuminuria. Geometric mean (lower and upper quartiles) in UAER mgram/min from baseline to end of study were for the valsartan group: 57.97(33.0,102.3) to 32.3(18.2,59.7) and for amlodipine: 55.4(34.3,84.6) to 50.7(31.8,85.6) (p<0.001). In addition, more patients returned to normal albuminuric status after 24 weeks with Diovan (29.9%) vs amlodipine (14.5%) (p=0.001). The Diovan and amlodipine groups experienced similar rates of blood pressure reduction. Mean systolic blood pressure decreased by 11.2 mm/Hg in Diovan patients and by 11.6 mm/Hg in amlodipine patients. Similarly, mean diastolic pressure decreased by 6.6 mm/Hg in Diovan patients compared with a decrease of 6.5 mm/Hg in patients who took amlodipine.

Many medical experts are calling for more aggressive treatment of high blood pressure to preserve optimal kidney function and prevent strokes and heart attacks in individuals whose kidneys have been damaged by diabetes. New guidelines issued by the National Kidney Foundation set a lower target for blood pressure of 125/75 mm/Hg in patients with proteinuria (abnormal amounts of protein in the urine). Notably, upon entering the study, 84% of MARVAL patients had blood pressure greater than or equal to 125/75 mm/Hg.

An earlier study by Muirhead et al also showed Diovan was effective in lowering microalbuminuria. This multi-center, randomized, double-blind, placebo-controlled study compared the safety and efficacy of Diovan 80 mg once-daily, Diovan 160 mg once-daily, the ACE inhibitor captopril 25 mg three times daily and placebo in 122 type 2 diabetes patients with both normal and high blood pressure. The one-year study showed that Diovan was as effective in slowing the progressive rise of microalbuminuria as captopril. The total number of patients who experienced adverse effects was highest in the captopril group and lowest with Diovan 80 mg: 34.5% in the captopril group vs 22.6% in the Diovan 160 mg group vs 9.7% in the Diovan 80 mg group vs 13.8% in the placebo group. The incidence of trial drug-related dry cough was also highest in the captopril group.

Novartis is conducting one of the world's largest clinical trial programs with an ARB. The trials, which include the completed Val-HeFT (heart failure patients) and the ongoing VALUE (high-risk patients with hypertension) and VALIANT (post-myocardial infarction patients), examine the effect of Diovan beyond its existing indication for hypertension. Diovan is also the primary agent in a clinical trial involving adult type 2 diabetes patients with either normal or high blood pressure (ABCD-2V).

About three million patients worldwide take Diovan for high blood pressure and it is the fastest growing top 10 branded antihypertensive in the US today.

All ARBs carry a warning that the drug should not be used in pregnant women due to the risk of injury and even death to the fetus. The most common adverse events seen in controlled clinical trials with Diovan were headache and dizziness. For more information or a copy of the full prescribing information for Diovan, please visit the Novartis website at and select Diovan.

About Novartis

Novartis Pharmaceuticals Corporation is a member of the American Heart Association (AHA) Pharmaceutical Roundtable, a strategic coalition of leading pharmaceutical companies who support the AHA's mission by supporting its cardiovascular research and educational programs. Novartis is also a Corporate Member of the Heart Failure Society of America. Novartis is also working with the Association of Black Cardiologists on two education initiatives for African Americans: Operation H.U.S.H. (Hypertension Unchecked Silences Hearts) and "Children Should Know Their Grandparents, A Guide to a Healthy Heart."

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of the Novartis Group (NYSE: NVS), 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, the Novartis Group employs about 67,600 people and operates in over 140 countries around the world. For further information please consult .

The foregoing press statement contains forward-looking statements that can be identified by terminology such as "could," "examine," "implication" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. In particular, management's expectations could be affected by, among other things, uncertainties relating to clinical trials.

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Publication:PR Newswire
Date:May 17, 2001
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