November 2001

From University of Minnesota

New Val-HeFT data shows valsartan reduces total heart failure hospitalizations

Anaheim, Calif., November 13, 2001 – Researchers from the University of Minnesota Medical School presented new findings from the Valsartan Heart Failure Trial (Val-HeFT) during the American Heart Association (AHA) Scientific Sessions 2001. According to the new data, the angiotensin II receptor blocker (ARB) valsartan reduces not only the time to first hospitalization for heart failure but all hospitalizations for this devastating disease. A separate analysis of neurohormonal data from Val-HeFT demonstrated that valsartan has positive effects on norepinephrine, a neurohormone associated with morbidity outcomes in heart failure patients.

Heart failure is the fastest growing cardiovascular disease in the world and the leading cause of hospitalization in people over age 65. Valsartan is a medication for high blood pressure. Val-HeFT was sponsored by Novartis Pharma AG, manufacturers of valsartan.

"Val-HeFT previously showed that valsartan significantly delays or prevents patients’ first hospitalizations for heart failure," said Jay N. Cohn, M.D., cardiovascular division, University of Minnesota Medical School. "The new analysis demonstrates that the benefits of valsartan on heart failure hospitalization were consistent throughout the trial and that valsartan not only reduces first but subsequent hospitalizations for this disease." Cohn presented the new analysis at AHA and is the lead investigator for Val-HeFT.

The analysis showed valsartan reduced the total number of hospitalizations for heart failure by 22.3% vs. placebo (923 vs. 1188; p=0.002). Previously released findings of Val-HeFT demonstrate valsartan reduces time to first hospitalization for heart failure by 27.5% (p<0.001) and also reduces heart failure morbidity by 13.2% (p=0.09).

A multinational study of 5,010 patients at 302 centers in 16 countries, Val-HeFT assessed the efficacy of valsartan vs. placebo in heart failure patients who also took appropriate therapy prescribed by their physicians. Val-HeFT is the largest study ever conducted in heart failure and the largest study of neurohormonal data in patients with this disease. Neurohormone levels are monitored in heart failure because they are associated with morbidity outcomes.

In a separate analysis of the neurohormonal data from Val-HeFT, University of Minnesota researchers concluded that valsartan has favorable effects on a neurohormone called norepinephrine.

"Norepinephrine is well documented as a marker for heart failure morbidity," said Dr. Inder Anand, who presented the analysis and is a Val-HeFT Investigator and professor of cardiology. "The favorable effects of valsartan on norepinephrine are consistent with the strong reduction in heart failure morbidity seen with this agent."

The analysis demonstrated that circulating levels of norepinephrine rose significantly higher over the course of the study in heart failure patients taking placebo vs. those taking valsartan. Changes in norepinephrine were assessed at 4, 12 and 24 months. Norepinephrine increased steadily during 24 months of follow up in the placebo group (baseline mean 472±368 SD), while the increase in norepinephrine over time was significantly attenuated in valsartan patients (baseline mean 456±270 SD).

Heart failure develops when the heart is unable to pump blood efficiently because of injury from a heart attack, high blood pressure, damage to the heart muscle (cardiomyopathy), or other causes. Worldwide, the prevalence of heart failure is 20 million and rising dramatically. Heart failure is the major cause of hospitalization in Medicare patients. About one million Americans were hospitalized in the last year for heart failure – more than triple the number of patients hospitalized for this condition two decades ago.

The University of Minnesota is a state land-grant with an annual enrollment of more than 58,000 students on its four campuses. Information about the University’s Academic Health center can be found at www.ahc.umn.edu.

Contacts:

Jay N. Cohn, M.D., professor of cardiology, University of Minnesota

Inder Anand, M.D., professor of cardiology, University of Minnesota and VA Medical Center

Sarah Youngerman, University of Minnesota, (612) 624-4604

Deane Morrison, University News Service, (612) 624-2346












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