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Study suggests inexpensive drug cuts heart-failure deaths by one-third

From the New England Journal of Medicine Online:
Article: The Effect of Spironolactone on Morbidity and Mortality in Patients with Severe Heart Failure

Editorial: Aldosterone and Spironolactone in Heart Failure
CNN's Rhonda Rowland reports on a study that suggests an inexpensive drug, Aldactone, cuts heart-failure deaths
Windows Media 28K 80K

July 20, 1999
Web posted at: 10:17 a.m. EDT (1417 GMT)

From Medical Correspondent Rhonda Rowland

ATLANTA (CNN) -- Deeming the news important enough to release ahead of scheduled publication, a major medical journal on Monday is quoting a study that suggests an inexpensive drug could save lives in the treatment of heart patients.

The New England Journal of Medicine (NEJM) report says the new study shows adding the drug Aldactone to standard therapy for severe heart failure reduced deaths by 30 percent and hospitalizations by 36 percent in participating patients. The study was sponsored by Searle, maker of Aldactone, a drug long on the market.

"This has a tremendous benefit to patients," says lead researcher Dr. Bertram Pitt of the University of Michigan, "but this also has tremendous public health benefit, because this drug has been around for 30 years, and it's available right now in the drugstores, and it's very, very cheap."

According to the American Heart Association, close to five million people in the United States suffer from chronic heart failure.

The study results were scheduled to be published by the NEJM in September, but the manuscript was instead posted Monday on its Web site ( The NEJM only releases manuscripts early when it's determined that research findings have immediate clinical implications.

The study, performed in 15 countries on more than 1,600 patients with severe heart failure was halted 18 months early by an independent oversight committee because the results were seen as so significant that it would have been unethical to continue the trial.

Many physicians had feared Aldactone would raise potassium levels to dangerous levels and would be unsafe. But the study suggests that Aldactone is safe when used in conjunction with current heart therapies, although potassium levels still should be monitored.

Another possible side effect of Aldactone in men is gynecomastia or enlargement of the breasts. This effect occurred in 10 percent of the study participants. Dr. Pitt says resulting breast enlargement wasn't severe, just annoying.

Aldactone is the branded version of the compound spironolactone and several companies make generic versions of the drug.

Searle researchers are working on a new version of the drug, in hopes of eliminating the breast-enlargement side effect seen in some men treated. The company doesn't expect the modified drug to be available for a few more years.

Searle officials say they hope to learn whether Aldactone has the same life-saving benefit for patients suffering from hypertension and from less severe forms of heart failure.

Medical Producer Karen Klaus contributed to this report.

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New England Journal of Medicine
Searle Healthnet
American Heart Association National Center
University of Michigan
Mayo Clinic: Ask the Mayo Physician - gynecomastia
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