December 2001

From University of Minnesota

Study identifies new treatment option for heart failure patients

MINNEAPOLIS/ST. PAUL--Final results of the Valsartan Heart Failure Trial (Val-HeFT) published in the Dec. 5 New England Journal of Medicine demonstrate that adding the angiotensin II receptor blocker (ARB) valsartan to prescribed therapy for patients with heart failure leads to significant, incremental improvements in symptoms and in outcomes.

Val-HeFT showed that valsartan decreased morbidity from heart failure by a statistically significant 13.2 percent (p=0.009) and reduced hospitalizations for heart failure by 27.5 percent (p<0.001) in patients already taking heart failure therapy prescribed by their physicians. The Val-HeFT clinical trial was sponsored by Novartis Pharma AG, manufacturers of valsartan.

"Val-HeFT identified a critical role for valsartan in the management of heart failure," said Jay N. Cohn, M.D., professor of medicine, cardiovascular division, University of Minnesota Medical School and Val-HeFT lead investigator. "Despite several potent drugs with proven benefits, impaired quality of life and recurring hospitalization are detrimental to both patients and the healthcare system. Val-HeFT shows that valsartan improves outcomes in patients with this devastating disease."

The largest study ever completed in heart failure--and the first completed study to show positive effects on patient outcomes with an ARB--Val-HeFT compared the efficacy of valsartan to placebo in patients who continued to receive all other appropriate heart failure therapy, which included ACE inhibitors, beta blockers, diuretics and digoxin.

A multinational trial of a diverse population of 5,010 patients from 302 centers in 16 countries, Val-HeFT had two primary endpoints: combined mortality and morbidity (including sudden death with resuscitation, hospitalization and administration of IV inotropic or vasodilating agents for heart failure); and all-cause mortality.

The findings of Val-HeFT across cardiovascular endpoints were consistently positive. Besides the 13.2 percent reduction in heart failure morbidity, other findings of Val-HeFT were significant improvements in patients' New York Heart Association (NYHA) classification (p<0.001), indicating favorable effects on disease progression; significant improvements in ejection fraction (p=0.001); and significant improvements in clinical signs and symptoms of heart failure (dyspnea, fatigue, edema and rales) (p=0.01). Valsartan patients also experienced significantly better quality of life (p=0.005) as measured by the Minnesota Living with Heart Failure questionnaire. The rate of all-cause mortality was similar between study arms.

The beneficial effects of valsartan were generally consistent across Val-HeFT patient subgroups regardless of age, gender, or co-existing conditions such as diabetes and coronary artery disease. Valsartan therapy was also generally well tolerated. Adverse events leading to withdrawal occurred in 9.9 percent of patients receiving valsartan and 7.3 percent of patients receiving placebo (P<0.001). The most commonly reported adverse events included dizziness and hypotension. Clinical benefits were not observed in patients who took valsartan in combination with both an ACE inhibitor and beta blocker.

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.

In the United States, heart failure currently affects five million Americans, and more than 500,000 new cases are detected each year. Because more people survive heart attacks than ever before, it is expected that more people will develop heart failure. Heart failure is also the major cause of hospitalization in the Medicare population. Costs for treating heart failure are expected to exceed $50 billion this year in the United States. 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.

Contacts:
Jay N. Cohn, M.D., professor of cardiology, University of Minnesota
Sarah Youngerman, Academic Health Center, 612-624-4604, syounger@umn.edu
Deane Morrison, University News Service, 612-624-2346, morri029@umn.edu












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