DOCTOR'S VIEW ARCHIVE

Heart Failure ... Old Drug, New Therapy

The New England Journal of Medicine removed the embargo on an unpublished article (1999) and accompanying editorial about the clinical implications of an advance in the treatment of heart failure. The advance involves a drug called spironolactone (pronounced spi-ro-no-lac-tone) that has been manufactured by G.D. Searle & Co. for some years under the brand name of Aldactone and is available as a generic drug. The news about spironolactone is twofold:

  1. Spironolactactone is a major help in treating congestive heart failure; and very importantly
  2. Its beneficial effects are additive to those from ACE inhibitors, another class of drugs commonly relied on in treating heart failure.

The research was reported by Bernard Pitt and colleagues in what was called the Randomized Aldactone Evaluation Study (RALES). The RALES study was unusually far-flung. It took place on 5 continents in 15 countries -- Belgium, Brazil, Canada, France, Germany, Japan, Mexico, The Netherlands, New Zealand, South Africa, Spain, Switzerland, the United Kingdom, the U.S. and Venezuela. At 195 medical centers, a grand total of 1663 patients with symptomatic heart failure were studied. All received standard care and, in addition, they were assigned randomly (by chance alone) to receive spironolactone or a placebo, a blank that looked just like spironolactone.

Results of the research

The overall risks of death, death due to progressive heart failure, and sudden death from cardiac causes were all found to be lowered by about 30% among the patients treated with spironolactone. This remarkable result prompted the RALES study to be ended early so that all of the patients could receive spironolactone and benefit from it.