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

Publication ,  Journal Article
Felker, GM; Mentz, RJ; Cole, RT; Adams, KF; Egnaczyk, GF; Fiuzat, M; Patel, CB; Echols, M; Khouri, MG; Tauras, JM; Gupta, D; Monds, P ...
Published in: J Am Coll Cardiol
March 21, 2017

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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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

March 21, 2017

Volume

69

Issue

11

Start / End Page

1399 / 1406

Location

United States

Related Subject Headings

  • Tolvaptan
  • Prospective Studies
  • Middle Aged
  • Male
  • Kidney Function Tests
  • Humans
  • Heart Failure
  • Female
  • Dyspnea
  • Double-Blind Method
 

Citation

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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. J Am Coll Cardiol, 69(11), 1399–1406. https://doi.org/10.1016/j.jacc.2016.09.004
Felker, G Michael, Robert J. Mentz, Robert T. Cole, Kirkwood F. Adams, Gregory F. Egnaczyk, Mona Fiuzat, Chetan B. Patel, et al. “Efficacy and Safety of Tolvaptan in Patients Hospitalized With Acute Heart Failure.J Am Coll Cardiol 69, no. 11 (March 21, 2017): 1399–1406. https://doi.org/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. J Am Coll Cardiol. 2017 Mar 21;69(11):1399–406.
Felker, G. Michael, et al. “Efficacy and Safety of Tolvaptan in Patients Hospitalized With Acute Heart Failure.J Am Coll Cardiol, vol. 69, no. 11, Mar. 2017, pp. 1399–406. Pubmed, doi:10.1016/j.jacc.2016.09.004.
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. Efficacy and Safety of Tolvaptan in Patients Hospitalized With Acute Heart Failure. J Am Coll Cardiol. 2017 Mar 21;69(11):1399–1406.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

March 21, 2017

Volume

69

Issue

11

Start / End Page

1399 / 1406

Location

United States

Related Subject Headings

  • Tolvaptan
  • Prospective Studies
  • Middle Aged
  • Male
  • Kidney Function Tests
  • Humans
  • Heart Failure
  • Female
  • Dyspnea
  • Double-Blind Method