THE FASTEST-GROWING branded high blood pressure treatment in the world, Diovan (valsartan), is also a potentially life-saving treatment after a heart attack, according to the findings of VALIANT, a major new study announced on Monday at the American Heart Association Scientific Sessions 2003 and published online in the New England Journal of Medicine. VALIANT (VALsartan In Acute myocardial iNfarcTion) is the largest long-term study ever conducted in people who have survived a heart attack. This critical new data set helps establish Diovan as a highly desirable and powerful first-line option for an increasingly wide patient population.
"We are very pleased with the results of the VALIANT trial, which showed that Diovan is the first and only angiotensin II receptor blocker (ARB) proven to be as cardioprotective as the current standard of care following a heart attack," said Joerg Reinhardt, head of Development, Novartis Pharma AG. "When these data are combined with the strong benefits Diovan provides for blood pressure lowering, excellent tolerability and long-term patient persistency with therapy, they are very compelling for patients, as well as physicians." Novartis plans to file very soon for a post-MI indication.
MULTIPLE BENEFITS
Based on VALIANT and the cumulative clinical evidence being gathered for Diovan in hypertension, Novartis will accelerate clinical programmes designed to demonstrate that Diovan has important blood pressure lowering, patient compliance and vascular health benefits beyond ACE inhibitors (angiotensin-converting-enzyme inhibitors).
"We believe Diovan is well on its way to becoming the new standard of care and we are committed to its continued success," added Reinhardt.
VALIANT provides important new answers to clinical questions.
A rigorous head-to-head comparison of Diovan against captopril, VALIANT studied 14 703 patients at the highest risk for death following a heart attack (myocardial infarction) for an average of two years. VALIANT also studied the effects of combination treatment with Diovan and the ACE inhibitor in these patients.
CHANGE ON HORIZON
VALIANT demonstrated that Diovan has all the established life-saving benefits of captopril in heart attack patients and was at least as effective as the ACE inhibitor in reducing cardiac events following a heart attack, including repeat heart attacks and hospitalisations for heart failure. Diovan is the only cardiovascular agent ever demonstrated by a head-to-head trial to have all of the proven benefits of an ACE inhibitor in patients following a heart attack. No added benefits were seen with combination treatment.
"VALIANT was a major international study that will change treatment guidelines," said Marc Pfeffer, MD, PhD, the chair of the VALIANT study, who is a Professor of Medicine at Harvard Medical School and Senior Physician at Brigham and Women's Hospital, Boston. "We have proven that valsartan is as effective as an ACE inhibitor at prolonging life and preventing recurrent heart attacks and hospitalisations for heart failure. This is significant because it provides physicians with a new option for treating high-risk heart attack survivors."
Approved for the first-line treatment of high blood pressure in more than 80 countries and for heart failure in more than 40 countries, Diovan is the most widely prescribed drug in its class and the fastest growing branded high blood pressure treatment in the world. VALIANT now demonstrates Diovan is an effective option for first-line treatment of high-risk patients following a heart attack.
