New Heart Failure Drug Approved by FDA

Oct. 8, 2003 -- People whose hearts are weakened or damaged by a heart attack will soon have access to a new drug that promises to reduce their risk of death by as much as 15%.

The FDA today approved Inspra, a member of a class of drugs known as aldosterone blockers, for the treatment of congestive heart failure following a heart attack.

Researchers say more than five million Americans suffer from congestive heart failure -- a progressive disease that occurs when the heart is damaged by a heart attack or high blood pressure. Essentially, the heart can no longer pump enough blood to the body effectively. More than one-third of heart attack survivors develop the condition, and are at higher risk of death.

The FDA approved Inspra ( eplerenone) tablets based on the results of a clinical trial involving 6,600 people who had been hospitalized for heart attacks. The study found that patients who received Inspra in addition to standard treatment had a 15% lower risk of death compared with those who received the placebo.

Drug Improves Current Therapy

Standard treatment for people with congestive heart failure after a heart attack currently includes heart surgery and/or a combination of drugs, such as ACE inhibitors, statins, beta blockers, and aspirin.

"We've clearly shown we can do better by adding an aldosterone blocker," says researcher Bertram Pitt, MD, professor of internal medicine at University of Michigan, Ann Arbor.

Researchers say aldosterone is one of three hormones in the body that are associated with the risks commonly seen in congestive heart failure patients. Inspra works by blocking the effects of that hormone.

The study, published in the April 3, 2003 issue of the New England Journal of Medicine, found adding Inspra to traditional congestive heart failure treatment produced a 15% reduction in deaths from any cause, 17% less heart-related deaths, and a 13% drop in combined heart-related deaths and hospitalizations.

Side effects of the drug include elevated blood potassium levels and increased blood creatinine, which may indicate kidney dysfunction. A decrease in the function of the kidneys means they may not be able to filter toxins from the blood as they normally do.

The FDA previously approved Inspra in 2002 for the treatment of hypertension. Pfizer Inc., which manufactures Inspra, says the once-a-day tablet should be available by the end of the year.