Efficacy and Safety of Tolvaptan in Patients Hospitalized With Acute Heart Failure

G. Michael Felker, Robert J. Mentz, Robert T. Cole, Kirkwood F. Adams, Gregory F. Egnaczyk, Mona Fiuzat, Chetan B. Patel, Melvin Echols, Michel G. Khouri, James M. Tauras, Divya Gupta, Pamela Monds, Rhonda Roberts, Christopher M. O'Connor

Research output: Contribution to journalArticle

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Abstract

Background The oral vasopressin-2 receptor antagonist tolvaptan causes aquaresis in patients with volume overload, potentially facilitating decongestion and improving the clinical course of patients with acute heart failure (AHF). Objectives The TACTICS-HF (Targeting Acute Congestion with Tolvaptan in Congestive Heart Failure) study was conducted to address the acute use of tolvaptan to improve congestion in AHF. Methods The TACTICS-HF study randomized patients (n = 257) within 24 h of AHF presentation in a prospective, double blind, placebo-controlled trial. Patients were eligible regardless of ejection fraction, and were randomized to either 30 mg of tolvaptan or placebo given at 0, 24, and 48 h, with a fixed-dose furosemide regimen as background therapy. The primary endpoint was the proportion of patients considered responders at 24 h. Secondary endpoints included symptom improvement, changes in renal function, and clinical events. Results Dyspnea relief by Likert scale was similar between groups at 8 h (25% moderately or markedly improved with tolvaptan vs. 28% placebo; p = 0.59) and at 24 h (50% tolvaptan vs. 47% placebo; p = 0.80). Need for rescue therapy was also similar at 24 h (21% tolvaptan, 18% placebo; p = 0.57). The proportion defined as responders at 24 h (primary study endpoint) was 16% for tolvaptan and 20% for placebo (p = 0.32). Tolvaptan resulted in greater weight loss and net fluid loss compared with placebo, but tolvaptan-treated patients were more likely to experience worsening renal function during treatment. There were no differences in in-hospital or post-discharge clinical outcomes. Conclusions In patients hospitalized with AHF, dyspnea, and congestion, the addition of tolvaptan to a standardized furosemide regimen did not improve the number of responders at 24 h, despite greater weight loss and fluid loss. (Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure [TACTICS-HF]; NCT01644331)

LanguageEnglish (US)
Pages1399-1406
Number of pages8
JournalJournal of the American College of Cardiology
Volume69
Issue number11
DOIs
StatePublished - Mar 21 2017

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Heart Failure
Safety
Placebos
Furosemide
tolvaptan
Dyspnea
Weight Loss
Kidney
Therapeutics

Keywords

  • acute heart failure
  • decongestion
  • outcomes
  • strategies
  • volume overload

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Felker, G. M., Mentz, R. J., Cole, R. T., Adams, K. F., Egnaczyk, G. F., Fiuzat, M., ... O'Connor, C. M. (2017). Efficacy and Safety of Tolvaptan in Patients Hospitalized With Acute Heart Failure. Journal of the American College of Cardiology, 69(11), 1399-1406. DOI: 10.1016/j.jacc.2016.09.004

Efficacy and Safety of Tolvaptan in Patients Hospitalized With Acute Heart Failure. / Felker, G. Michael; Mentz, Robert J.; Cole, Robert T.; Adams, Kirkwood F.; Egnaczyk, Gregory F.; Fiuzat, Mona; Patel, Chetan B.; Echols, Melvin; Khouri, Michel G.; Tauras, James M.; Gupta, Divya; Monds, Pamela; Roberts, Rhonda; O'Connor, Christopher M.

In: Journal of the American College of Cardiology, Vol. 69, No. 11, 21.03.2017, p. 1399-1406.

Research output: Contribution to journalArticle

Felker, GM, Mentz, RJ, Cole, RT, Adams, KF, Egnaczyk, GF, Fiuzat, M, Patel, CB, Echols, M, Khouri, MG, Tauras, JM, Gupta, D, Monds, P, Roberts, R & O'Connor, CM 2017, 'Efficacy and Safety of Tolvaptan in Patients Hospitalized With Acute Heart Failure' Journal of the American College of Cardiology, vol 69, no. 11, pp. 1399-1406. DOI: 10.1016/j.jacc.2016.09.004
Felker GM, Mentz RJ, Cole RT, Adams KF, Egnaczyk GF, Fiuzat M et al. Efficacy and Safety of Tolvaptan in Patients Hospitalized With Acute Heart Failure. Journal of the American College of Cardiology. 2017 Mar 21;69(11):1399-1406. Available from, DOI: 10.1016/j.jacc.2016.09.004
Felker, G. Michael ; Mentz, Robert J. ; Cole, Robert T. ; Adams, Kirkwood F. ; Egnaczyk, Gregory F. ; Fiuzat, Mona ; Patel, Chetan B. ; Echols, Melvin ; Khouri, Michel G. ; Tauras, James M. ; Gupta, Divya ; Monds, Pamela ; Roberts, Rhonda ; O'Connor, Christopher M./ Efficacy and Safety of Tolvaptan in Patients Hospitalized With Acute Heart Failure. In: Journal of the American College of Cardiology. 2017 ; Vol. 69, No. 11. pp. 1399-1406
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abstract = "Background The oral vasopressin-2 receptor antagonist tolvaptan causes aquaresis in patients with volume overload, potentially facilitating decongestion and improving the clinical course of patients with acute heart failure (AHF). Objectives The TACTICS-HF (Targeting Acute Congestion with Tolvaptan in Congestive Heart Failure) study was conducted to address the acute use of tolvaptan to improve congestion in AHF. Methods The TACTICS-HF study randomized patients (n = 257) within 24 h of AHF presentation in a prospective, double blind, placebo-controlled trial. Patients were eligible regardless of ejection fraction, and were randomized to either 30 mg of tolvaptan or placebo given at 0, 24, and 48 h, with a fixed-dose furosemide regimen as background therapy. The primary endpoint was the proportion of patients considered responders at 24 h. Secondary endpoints included symptom improvement, changes in renal function, and clinical events. Results Dyspnea relief by Likert scale was similar between groups at 8 h (25{\%} moderately or markedly improved with tolvaptan vs. 28{\%} placebo; p = 0.59) and at 24 h (50{\%} tolvaptan vs. 47{\%} placebo; p = 0.80). Need for rescue therapy was also similar at 24 h (21{\%} tolvaptan, 18{\%} placebo; p = 0.57). The proportion defined as responders at 24 h (primary study endpoint) was 16{\%} for tolvaptan and 20{\%} for placebo (p = 0.32). Tolvaptan resulted in greater weight loss and net fluid loss compared with placebo, but tolvaptan-treated patients were more likely to experience worsening renal function during treatment. There were no differences in in-hospital or post-discharge clinical outcomes. Conclusions In patients hospitalized with AHF, dyspnea, and congestion, the addition of tolvaptan to a standardized furosemide regimen did not improve the number of responders at 24 h, despite greater weight loss and fluid loss. (Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure [TACTICS-HF]; NCT01644331)",
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T1 - Efficacy and Safety of Tolvaptan in Patients Hospitalized With Acute Heart Failure

AU - Felker,G. Michael

AU - Mentz,Robert J.

AU - Cole,Robert T.

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AU - Egnaczyk,Gregory F.

AU - Fiuzat,Mona

AU - Patel,Chetan B.

AU - Echols,Melvin

AU - Khouri,Michel G.

AU - Tauras,James M.

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N2 - Background The oral vasopressin-2 receptor antagonist tolvaptan causes aquaresis in patients with volume overload, potentially facilitating decongestion and improving the clinical course of patients with acute heart failure (AHF). Objectives The TACTICS-HF (Targeting Acute Congestion with Tolvaptan in Congestive Heart Failure) study was conducted to address the acute use of tolvaptan to improve congestion in AHF. Methods The TACTICS-HF study randomized patients (n = 257) within 24 h of AHF presentation in a prospective, double blind, placebo-controlled trial. Patients were eligible regardless of ejection fraction, and were randomized to either 30 mg of tolvaptan or placebo given at 0, 24, and 48 h, with a fixed-dose furosemide regimen as background therapy. The primary endpoint was the proportion of patients considered responders at 24 h. Secondary endpoints included symptom improvement, changes in renal function, and clinical events. Results Dyspnea relief by Likert scale was similar between groups at 8 h (25% moderately or markedly improved with tolvaptan vs. 28% placebo; p = 0.59) and at 24 h (50% tolvaptan vs. 47% placebo; p = 0.80). Need for rescue therapy was also similar at 24 h (21% tolvaptan, 18% placebo; p = 0.57). The proportion defined as responders at 24 h (primary study endpoint) was 16% for tolvaptan and 20% for placebo (p = 0.32). Tolvaptan resulted in greater weight loss and net fluid loss compared with placebo, but tolvaptan-treated patients were more likely to experience worsening renal function during treatment. There were no differences in in-hospital or post-discharge clinical outcomes. Conclusions In patients hospitalized with AHF, dyspnea, and congestion, the addition of tolvaptan to a standardized furosemide regimen did not improve the number of responders at 24 h, despite greater weight loss and fluid loss. (Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure [TACTICS-HF]; NCT01644331)

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