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Spironolactone for heart failure with preserved ejection fraction.
- Source :
-
The New England journal of medicine [N Engl J Med] 2014 Apr 10; Vol. 370 (15), pp. 1383-92. - Publication Year :
- 2014
-
Abstract
- Background: Mineralocorticoid-receptor antagonists improve the prognosis for patients with heart failure and a reduced left ventricular ejection fraction. We evaluated the effects of spironolactone in patients with heart failure and a preserved left ventricular ejection fraction.<br />Methods: In this randomized, double-blind trial, we assigned 3445 patients with symptomatic heart failure and a left ventricular ejection fraction of 45% or more to receive either spironolactone (15 to 45 mg daily) or placebo. The primary outcome was a composite of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure.<br />Results: With a mean follow-up of 3.3 years, the primary outcome occurred in 320 of 1722 patients in the spironolactone group (18.6%) and 351 of 1723 patients in the placebo group (20.4%) (hazard ratio, 0.89; 95% confidence interval [CI], 0.77 to 1.04; P=0.14). Of the components of the primary outcome, only hospitalization for heart failure had a significantly lower incidence in the spironolactone group than in the placebo group (206 patients [12.0%] vs. 245 patients [14.2%]; hazard ratio, 0.83; 95% CI, 0.69 to 0.99, P=0.04). Neither total deaths nor hospitalizations for any reason were significantly reduced by spironolactone. Treatment with spironolactone was associated with increased serum creatinine levels and a doubling of the rate of hyperkalemia (18.7%, vs. 9.1% in the placebo group) but reduced hypokalemia. With frequent monitoring, there were no significant differences in the incidence of serious adverse events, a serum creatinine level of 3.0 mg per deciliter (265 μmol per liter) or higher, or dialysis.<br />Conclusions: In patients with heart failure and a preserved ejection fraction, treatment with spironolactone did not significantly reduce the incidence of the primary composite outcome of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure. (Funded by the National Heart, Lung, and Blood Institute; TOPCAT ClinicalTrials.gov number, NCT00094302.).
- Subjects :
- Aged
Aged, 80 and over
Cardiovascular Diseases mortality
Double-Blind Method
Female
Follow-Up Studies
Heart Failure mortality
Heart Failure physiopathology
Hospitalization statistics & numerical data
Humans
Incidence
Kaplan-Meier Estimate
Male
Middle Aged
Mineralocorticoid Receptor Antagonists adverse effects
Spironolactone adverse effects
Stroke Volume
Treatment Failure
Heart Failure drug therapy
Mineralocorticoid Receptor Antagonists therapeutic use
Spironolactone therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 370
- Issue :
- 15
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 24716680
- Full Text :
- https://doi.org/10.1056/NEJMoa1313731