Spironolactone for heart failure with preserved ejection fraction

Pitt, Bertram, Pfeffer, Marc A., Assmann, Susan F., Boineau, Robin, Anand, Inder S., Claggett, Brian, Clausell, Nadine, Desai, Akshay S., Diaz, Rafael, Fleg, Jerome L., Gordeev, Ivan, Harty, Brian, Heitner, John F., Kenwood, Christopher T., Lewis, Eldrin F., O'Meara, Eileen, Probstfield, Jeffrey L., Shaburishvili, Tamaz, Shah, Sanjiv J., Solomon, Scott D., Sweitzer, Nancy K., Yang, Song, McKinlay, Sonja M., TOPCAT Investigators and Ventura, H. (2014) Spironolactone for heart failure with preserved ejection fraction. New England Journal of Medicine, 370 15: 1383-1392. doi:10.1056/NEJMoa1313731

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Author Pitt, Bertram
Pfeffer, Marc A.
Assmann, Susan F.
Boineau, Robin
Anand, Inder S.
Claggett, Brian
Clausell, Nadine
Desai, Akshay S.
Diaz, Rafael
Fleg, Jerome L.
Gordeev, Ivan
Harty, Brian
Heitner, John F.
Kenwood, Christopher T.
Lewis, Eldrin F.
O'Meara, Eileen
Probstfield, Jeffrey L.
Shaburishvili, Tamaz
Shah, Sanjiv J.
Solomon, Scott D.
Sweitzer, Nancy K.
Yang, Song
McKinlay, Sonja M.
TOPCAT Investigators
Ventura, H.
Title Spironolactone for heart failure with preserved ejection fraction
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 1533-4406
Publication date 2014-04-10
Year available 2014
Sub-type Article (original research)
DOI 10.1056/NEJMoa1313731
Open Access Status File (Publisher version)
Volume 370
Issue 15
Start page 1383
End page 1392
Total pages 10
Place of publication Waltham, MA, United States
Publisher Massachussetts Medical Society
Language eng
Formatted 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.
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.
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.
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.
Keyword Medicine, General & Internal
General & Internal Medicine
Q-Index Code C1
Q-Index Status Provisional Code
Grant ID HHSN268200425207C
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
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