New England Journal of Medicine publishes important manuscript
Ann Arbor, Mich, Sept.2, 1999 -- A new study led by a leading University of Michigan heart researcher and published today in the New England Journal of Medicine shows that adding an established medication to standard treatment regimens for heart failure reduced deaths by 30 percent. The life-saving potential of the information caused the editorial staff to post the findings on its Internet site, www.nejm.org, in July.
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 at disease that, in the U.S. 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.
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.D., professor in the Division of Cardiology at the
U-M Medical School. These findings suggest that the gold standard treatment for
severe heart failure should include an
Contact: Kara Gavin, U. of Michigan Health System