Abstract | BACKGROUND AND METHODS: RESULTS: The trial was discontinued early, after a mean follow-up period of 24 months, because an interim analysis determined that spironolactone was efficacious. There were 386 deaths in the placebo group (46 percent) and 284 in the spironolactone group (35 percent; relative risk of death, 0.70; 95 percent confidence interval, 0.60 to 0.82; P<0.001). This 30 percent reduction in the risk of death among patients in the spironolactone group was attributed to a lower risk of both death from progressive heart failure and sudden death from cardiac causes. The frequency of hospitalization for worsening heart failure was 35 percent lower in the spironolactone group than in the placebo group (relative risk of hospitalization, 0.65; 95 percent confidence interval, 0.54 to 0.77; P<0.001). In addition, patients who received spironolactone had a significant improvement in the symptoms of heart failure, as assessed on the basis of the New York Heart Association functional class (P<0.001). Gynecomastia or breast pain was reported in 10 percent of men who were treated with spironolactone, as compared with 1 percent of men in the placebo group (P<0.001). The incidence of serious hyperkalemia was minimal in both groups of patients. CONCLUSIONS:
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Authors | B Pitt, F Zannad, W J Remme, R Cody, A Castaigne, A Perez, J Palensky, J Wittes |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 341
Issue 10
Pg. 709-17
(Sep 02 1999)
ISSN: 0028-4793 [Print] United States |
PMID | 10471456
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Angiotensin-Converting Enzyme Inhibitors
- Diuretics
- Mineralocorticoid Receptor Antagonists
- Spironolactone
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Topics |
- Aged
- Angiotensin-Converting Enzyme Inhibitors
(therapeutic use)
- Cause of Death
- Diuretics
(therapeutic use)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Gynecomastia
(chemically induced)
- Heart Diseases
(mortality)
- Heart Failure
(drug therapy, mortality)
- Hospitalization
(statistics & numerical data)
- Humans
- Hyperkalemia
(chemically induced)
- Male
- Middle Aged
- Mineralocorticoid Receptor Antagonists
(adverse effects, therapeutic use)
- Risk
- Spironolactone
(adverse effects, therapeutic use)
- Survival Analysis
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