Pfizer Inc has received approval from the U.S. Food and Drug Administration to market Inspra (eplerenone tablets) for the treatment of congestive heart failure in patients who have had a heart attack.

Inspra, an aldosterone blocker, works by inhibiting the effects of aldosterone, a hormone that may contribute to the development and progression of hypertension and congestive heart failure (CHF), including damage to blood vessels, kidney and the heart.

CHF is a common progressive disease that often occurs when the heart muscle is weakened after it has been injured from a heart attack or high blood pressure. It is estimated that nearly five million Americans suffer from CHF, and up to 700,000 new cases are diagnosed each year.

"Despite available treatments, congestive heart failure is still associated with high death rates and is a significant cardiovascular disorder in which the prevalence is increasing," said Dr. Joseph Feczko, Pfizer's executive vice president of Global Research and Development and president of Worldwide Development. "Inspra represents an important new life-saving therapy that will provide real benefits to those patients who have had a heart attack and suffer from congestive heart failure."

Patients who have had a heart attack are five times more likely to develop CHF than those who have not. Among patients over the age of 65, CHF is the number one reason for hospital admission and the leading cause of death. The costs to the health care system for treating CHF are estimated to be $20 billion to $40 billion annually.

The FDA approval of Inspra for this indication is based on results of the EPHESUS (Epleronone Post-AMI Heart Failure Efficacy and Survival Study) trial which showed that Inspra significantly reduced deaths in congestive heart failure patients after a heart attack, above and beyond standard therapy, which included angiotensin-converting enzyme inhibitors (ACEs) and beta-blockers.

Given the importance of this medication to patients with congestive heart failure post-MI, Inspra will be made available through a special Early Access program in November. Inspra will be available in December 2003.