|Drug therapy, even when safe and effective for serious health problems, can have a downside -- a hefty price tag. But there's good news for people suffering from left ventricular systolic dysfunction (LVSD) and congestive heart failure (CHF) following a heart attack. A study published today in Circulation: Journal of the American Heart Association, concludes the drug eplerenone can not only help many of these people live longer, it is also remarkably cost effective, according to lead author William S. Weintraub, MD, of the Emory Heart Center.
Eplerenone is in a class of medications that blocks aldosterone, a hormone involved in regulating blood levels of sodium and potassium as well as the constriction of blood vessels. Data from the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS), an international multi-center clinical trial, shows that CHF patients treated with eplerenone had a two percent absolute reduction in deaths compared to those given a placebo.
"We found a significant decrease in mortality," says Dr. Weintraub, Director of the Emory Center for Outcomes Research. "In addition to being medically effective, eplerenone is also cost effective, adding only about $3.60 (wholesale), on average, to treatment costs."
After a heart attack, about 22 percent of men and 46 percent of women develop CHF, which occurs when the heart loses some of its ability to pump blood through the body. When compared to heart attack patients without heart failure, those with CHF have double the risk of dying or suffering another heart attack within the first 30 days. To find out if eplerenone could lower that risk, EPHESUS researchers enrolled 6,632 patients at 671 medical centers in 37 countries between December 1999 and December 2001. All patients received optimal medical care, including standard medications (ACE inhibitors, diuretics, beta-blockers, and statins) and angioplasty to restore blood flow to the heart.
Approximately half the patients were given eplerenone in the randomized study while the others took placebo pills. After following the study participants an average of 16 months, the researchers found the eplerenone group had fewer deaths from all causes than the placebo treated patients. The treated group also had less specifically heart related deaths and fewer hospitalizations from cardiovascular problems.
"We also calculated patients' quality-adjusted life years by having EPHESUS participants answer questionnaires that rated their quality of life from one to zero, with one being a perfect life and zero being death. We then multiplied survival by that score to arrive at the quality-adjusted years. We found the average cost for each quality-life-year gained by the patients treated with eplerenone was $13,718. Health economists generally regard any price below $50,000 a year as cost-effective," explains Dr. Weintraub. "Clearly, EPHESUS has provided multiple reasons why eplerenone should be added to other standard therapies when heart failure develops following a heart attack."
Co-authors of the study are Emory researchers Zefeng Zhang, MD, Elizabeth M. Mahoney, ScD, and Paul Kolm, PhD; John A. Spertus, MD,MPH, of the Mid America Heart Institute; Jaime Caro, MD and Jack Ishak, MSc of the Caro Research Institute, Inc.; Robert Goldberg, PhD, of the University of Massachusetts; Joseph Tooley, PharmD, of Prudential Equity Group; Richard Willke, PhD, of Pfizer, Inc; and Bertram Pitt, MD, of the University of Michigan.
EPHESUS was funded by Pfizer, Inc., maker of eplerenone.