Heart failure deaths reduced by 30 percent with new drug regimen; New England Journal of Medicine provides advance look at important manuscript.

ANN ARBOR---A new study---led by a leading University of Michigan heart researcher and made public today by the New England Journal of Medicine---shows that adding an established medication to standard treatment regimens for heart failure reduced deaths by 30 percent. While the article will not appear in the journal until later this year, the life-saving potential of the information caused the editorial staff to post the findings on its Internet site, www.nejm.org .

The NEJM posts an early release of a manuscript on its Web site only two or three times a year in accordance with its Ingelfinger Rule, which allows the early release of findings determined to have immediate clinical implications. Such is the case in this heart failure study, where researchers observed a substantial reduction in mortality for a disease that, in the United States alone, affects as many as 4.7 million people and results in approximately 250,000 deaths annually, according to the American Heart Association.

The study looked at the effect of adding Aldactone (spironolactone), a drug that has been used for decades to treat a variety of conditions (see indications below) but had not been tested previously as therapy for reducing deaths in heart failure patients.

Known as the Randomized Aldactone Evaluation Study (RALES), the trial defies current thinking that spironolactone and other drugs that block the action of a hormone known as aldosterone should not be administered in conjunction with an ACE (angiotensin-converting-enzyme) inhibitor.

"Not only was combination therapy with Aldactone and ACE inhibitors well tolerated by patients in the most severe stages of heart failure, but the decrease in cardiac death and hospitalization was dramatic," said lead investigator Bertram Pitt, M
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Contact: Kara Gavin
kegavin@umich.edu
734-764-2220
University of Michigan
19-Jul-1999