The US Food & Drug Administration (FDA) approved a leading high blood pressure medicine Diovan (valsartan) to treat heart failure in patients who are intolerant of angiotensin-converting-enzyme (ACE) inhibitors, a common type of heart failure therapy. Diovan, an angiotensin II receptor blocker (ARB), is the top prescribed ARB franchise in the US and the first drug in its class to obtain an indication beyond hypertension.
Diovan represents a therapeutic advance in the treatment of heart failure as the first major new type of drug to be approved in the US for this life-threatening disease in five years. Heart failure is the fastest growing cardiovascular disease in the world and is characterized by a progressive weakening of the heart muscle until it no longer pumps blood effectively.
"Nearly five million Americans have heart failure and 1,500 new cases are discovered every day. However, many heart failure patients are not adequately treated due to side effects and other issues with available medications. So, mortality from heart failure remains unacceptably high and quality of life is low," said Jay N. Cohn, MD, Professor of Medicine, Cardiovascular Division, University of Minnesota Medical School, and lead investigator of the Valsartan Heart Failure Trial (Val-HeFT) - one of the largest studies ever conducted in heart failure. "The availability of Diovan is a critical new development for heart failure patients who desperately need alternative options that not only prolong life and slow the progression of disease, but also help them live successfully with this chronic condition."
The primary basis for the new US indication was Val-HeFT, a study of 5,010 heart failure patients from 16 countries. The overall results of Val-HeFT show Diovan improves heart failure morbidity and slows the progression of disease vs. placebo in patients taking other heart failure therapy prescribed by their physicians. Overall mortality was similar in the Diovan and placebo groups. In Val-HeFT, Diovan provided the greatest benefit in patients who did not take an ACE inhibitor. In these patients, Diovan improved survival by 41 per cent, reduced morbidity (illness) by 49 per cent and cut the risk for hospitalization for heart failure by 57 per cent.
Treatment guidelines by the American Heart Association and American College of Cardiology already support the use of Diovan in heart failure patients who cannot tolerate ACE inhibitors. While ACE inhibitors have known benefits in heart failure, it is estimated that 24 per cent - 54 per cent of patients do not receive these drugs because of intolerance or other reasons.
Heart failure is caused by many factors, including a heart attack or other injury to the heart, abnormalities in heart valves or muscle walls, clogged arteries, or long-term high blood pressure. Three out of four heart failure patients have a history of high blood pressure. Ironically, progress in treating cardiovascular risk factors and disease is helping more people live longer, which has led to an unfortunate increase in the prevalence of heart failure. Besides being lethal, heart failure causes patients' quality of life to deteriorate, making it difficult for them to do simple, routine activities such as walking or climbing stairs. As the heart stops pumping blood efficiently, fluid seeps into the lungs causing frightening shortness of breath. Patients are so frequently hospitalized for heart failure that it has become the leading cause of hospitalization in Americans over age 65.