Influence of ejection fraction on outcomes and efficacy of spironolactone in patients with heart failure with preserved ejection fraction

Scott D. Solomon, Brian Claggett, Eldrin F. Lewis, Akshay Desai, Inder Anand, Nancy K Sweitzer, Eileen O'meara, Sanjiv J. Shah, Sonja Mckinlay, Jerome L. Fleg, George Sopko, Bertram Pitt, Marc A. Pfeffer

Research output: Contribution to journalArticle

103 Citations (Scopus)

Abstract

Aims While mineralocorticoid receptor antagonists (MRAs) have been shown to benefit patients with reduced left ventricular ejection fraction (LVEF), spironolactone did not reduce the primary endpoint of cardiovascular death, heart failure hospitalization, or aborted cardiac arrest in patients with heart failure with preserved ejection fraction (HFpEF) in the TOPCAT trial, which enrolled patients with LVEF of 45% or greater. We utilized data from TOPCAT to assess the relationship between LVEF as well as outcomes and efficacy of spironolactone. Methods and results We assessed differences in baseline characteristics and outcomes across LVEF categories in 3444 patients with HFpEF, and determined whether LVEF modified the treatment effect of spironolactone. Ejection fraction ranged from 44 to 85%. Patients with higher ejection fraction were older, more likely to be female, less likely to have a history of myocardial infarction, and more likely to have a history of hypertension and diabetes. The incidence of the primary endpoint and cardiovascular death was highest in patients at the lower end of the ejection fraction spectrum. Ejection fraction modified the spironolactone treatment effect, particularly in the patients enrolled in the Americas, for the primary outcome (P = 0.046) and for heart failure hospitalization (P = 0.039), with stronger estimated benefits of spironolactone at the lower end of the ejection fraction spectrum with respect to the primary endpoint (LVEF

Original languageEnglish (US)
Pages (from-to)455-462
Number of pages8
JournalEuropean Heart Journal
Volume37
Issue number5
DOIs
StatePublished - Feb 1 2016

Fingerprint

Spironolactone
Stroke Volume
Heart Failure
Hospitalization
Mineralocorticoid Receptor Antagonists
Heart Arrest
Myocardial Infarction
Hypertension
Incidence
Therapeutics

Keywords

  • Heart failure with preserved ejection fraction
  • Spironolactone

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Influence of ejection fraction on outcomes and efficacy of spironolactone in patients with heart failure with preserved ejection fraction. / Solomon, Scott D.; Claggett, Brian; Lewis, Eldrin F.; Desai, Akshay; Anand, Inder; Sweitzer, Nancy K; O'meara, Eileen; Shah, Sanjiv J.; Mckinlay, Sonja; Fleg, Jerome L.; Sopko, George; Pitt, Bertram; Pfeffer, Marc A.

In: European Heart Journal, Vol. 37, No. 5, 01.02.2016, p. 455-462.

Research output: Contribution to journalArticle

Solomon, SD, Claggett, B, Lewis, EF, Desai, A, Anand, I, Sweitzer, NK, O'meara, E, Shah, SJ, Mckinlay, S, Fleg, JL, Sopko, G, Pitt, B & Pfeffer, MA 2016, 'Influence of ejection fraction on outcomes and efficacy of spironolactone in patients with heart failure with preserved ejection fraction', European Heart Journal, vol. 37, no. 5, pp. 455-462. https://doi.org/10.1093/eurheartj/ehv464
Solomon, Scott D. ; Claggett, Brian ; Lewis, Eldrin F. ; Desai, Akshay ; Anand, Inder ; Sweitzer, Nancy K ; O'meara, Eileen ; Shah, Sanjiv J. ; Mckinlay, Sonja ; Fleg, Jerome L. ; Sopko, George ; Pitt, Bertram ; Pfeffer, Marc A. / Influence of ejection fraction on outcomes and efficacy of spironolactone in patients with heart failure with preserved ejection fraction. In: European Heart Journal. 2016 ; Vol. 37, No. 5. pp. 455-462.
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abstract = "Aims While mineralocorticoid receptor antagonists (MRAs) have been shown to benefit patients with reduced left ventricular ejection fraction (LVEF), spironolactone did not reduce the primary endpoint of cardiovascular death, heart failure hospitalization, or aborted cardiac arrest in patients with heart failure with preserved ejection fraction (HFpEF) in the TOPCAT trial, which enrolled patients with LVEF of 45{\%} or greater. We utilized data from TOPCAT to assess the relationship between LVEF as well as outcomes and efficacy of spironolactone. Methods and results We assessed differences in baseline characteristics and outcomes across LVEF categories in 3444 patients with HFpEF, and determined whether LVEF modified the treatment effect of spironolactone. Ejection fraction ranged from 44 to 85{\%}. Patients with higher ejection fraction were older, more likely to be female, less likely to have a history of myocardial infarction, and more likely to have a history of hypertension and diabetes. The incidence of the primary endpoint and cardiovascular death was highest in patients at the lower end of the ejection fraction spectrum. Ejection fraction modified the spironolactone treatment effect, particularly in the patients enrolled in the Americas, for the primary outcome (P = 0.046) and for heart failure hospitalization (P = 0.039), with stronger estimated benefits of spironolactone at the lower end of the ejection fraction spectrum with respect to the primary endpoint (LVEF",
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AU - Solomon, Scott D.

AU - Claggett, Brian

AU - Lewis, Eldrin F.

AU - Desai, Akshay

AU - Anand, Inder

AU - Sweitzer, Nancy K

AU - O'meara, Eileen

AU - Shah, Sanjiv J.

AU - Mckinlay, Sonja

AU - Fleg, Jerome L.

AU - Sopko, George

AU - Pitt, Bertram

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N2 - Aims While mineralocorticoid receptor antagonists (MRAs) have been shown to benefit patients with reduced left ventricular ejection fraction (LVEF), spironolactone did not reduce the primary endpoint of cardiovascular death, heart failure hospitalization, or aborted cardiac arrest in patients with heart failure with preserved ejection fraction (HFpEF) in the TOPCAT trial, which enrolled patients with LVEF of 45% or greater. We utilized data from TOPCAT to assess the relationship between LVEF as well as outcomes and efficacy of spironolactone. Methods and results We assessed differences in baseline characteristics and outcomes across LVEF categories in 3444 patients with HFpEF, and determined whether LVEF modified the treatment effect of spironolactone. Ejection fraction ranged from 44 to 85%. Patients with higher ejection fraction were older, more likely to be female, less likely to have a history of myocardial infarction, and more likely to have a history of hypertension and diabetes. The incidence of the primary endpoint and cardiovascular death was highest in patients at the lower end of the ejection fraction spectrum. Ejection fraction modified the spironolactone treatment effect, particularly in the patients enrolled in the Americas, for the primary outcome (P = 0.046) and for heart failure hospitalization (P = 0.039), with stronger estimated benefits of spironolactone at the lower end of the ejection fraction spectrum with respect to the primary endpoint (LVEF

AB - Aims While mineralocorticoid receptor antagonists (MRAs) have been shown to benefit patients with reduced left ventricular ejection fraction (LVEF), spironolactone did not reduce the primary endpoint of cardiovascular death, heart failure hospitalization, or aborted cardiac arrest in patients with heart failure with preserved ejection fraction (HFpEF) in the TOPCAT trial, which enrolled patients with LVEF of 45% or greater. We utilized data from TOPCAT to assess the relationship between LVEF as well as outcomes and efficacy of spironolactone. Methods and results We assessed differences in baseline characteristics and outcomes across LVEF categories in 3444 patients with HFpEF, and determined whether LVEF modified the treatment effect of spironolactone. Ejection fraction ranged from 44 to 85%. Patients with higher ejection fraction were older, more likely to be female, less likely to have a history of myocardial infarction, and more likely to have a history of hypertension and diabetes. The incidence of the primary endpoint and cardiovascular death was highest in patients at the lower end of the ejection fraction spectrum. Ejection fraction modified the spironolactone treatment effect, particularly in the patients enrolled in the Americas, for the primary outcome (P = 0.046) and for heart failure hospitalization (P = 0.039), with stronger estimated benefits of spironolactone at the lower end of the ejection fraction spectrum with respect to the primary endpoint (LVEF

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