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Efficacy of Intravenous Furosemide Versus a Novel, pH-Neutral Furosemide Formulation Administered Subcutaneously in Outpatients With Worsening Heart Failure.

Publication ,  Journal Article
Gilotra, NA; Princewill, O; Marino, B; Okwuosa, IS; Chasler, J; Almansa, J; Cummings, A; Rhodes, P; Chambers, J; Cuomo, K; Russell, SD
Published in: JACC Heart Fail
January 2018

OBJECTIVES: This study sought to determine the efficacy and safety of a novel, pH-neutral formulation of furosemide administered subcutaneously (SC) for treatment of acute decompensated heart failure (HF). BACKGROUND: Congestion requiring intravenous (IV) administration of a diuretic agent is the main reason patients with HF present for acute medical care. METHODS: Outpatients presenting with decompensated HF were randomized to receive a single SC or IV dose of furosemide. Primary outcome was 6-h urine output, and secondary outcomes were weight change, natriuresis, and adverse events. RESULTS: Forty-one patients were randomized: 19 were treated with IV (mean dose: 123 ± 47 mg) and 21 with SC furosemide (fixed dose of 80 mg over 5 h). The 6-h urine output in the IV group was not significantly different from that in the SC furosemide group (median IV: 1,425 ml; interquartile range [IQR]: 1,075 to 1,950 ml; vs. median SC: 1,350 ml; IQR: 900 to 1,900 ml; p = 0.84). Additionally, mean weight loss was not significantly different (-1.5 ± 1.1 kg in the IV group vs. -1.5 ± 1.2 kg in the SC group; p = 0.95). Hourly urine output was significantly higher in the IV group at hour 2 (425 ml in the IV group vs. 250 ml in the SC group; p = 0.02) and higher in the SC group at hour 6 (125 ml, IV group vs. 325 ml, SC group; p = 0.005). Natriuresis was higher in the SC group (IV: 7.3 ± 35.3 mEq/l vs. SC: 32.8 ± 43.6 mEq/l; p = 0.05). There was no worsening renal function, ototoxicity, or skin irritation with either formulation. Thirty-day hospitalization rates were similar. CONCLUSIONS: In this phase II trial, we did not identify significant differences between urine output obtained with pH-neutral furosemide administered SC and that obtained by IV. This method of decongestion may allow treatment at home and reduced HF resources and warrants further investigation. (Sub-Q Versus IV Furosemide in Acute Heart Failure; NCT02579057).

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Published In

JACC Heart Fail

DOI

EISSN

2213-1787

Publication Date

January 2018

Volume

6

Issue

1

Start / End Page

65 / 70

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke Volume
  • Pilot Projects
  • Outpatients
  • Natriuresis
  • Middle Aged
  • Male
  • Injections, Subcutaneous
  • Injections, Intravenous
  • Hydrogen-Ion Concentration
 

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Gilotra, N. A., Princewill, O., Marino, B., Okwuosa, I. S., Chasler, J., Almansa, J., … Russell, S. D. (2018). Efficacy of Intravenous Furosemide Versus a Novel, pH-Neutral Furosemide Formulation Administered Subcutaneously in Outpatients With Worsening Heart Failure. JACC Heart Fail, 6(1), 65–70. https://doi.org/10.1016/j.jchf.2017.10.001
Gilotra, Nisha A., Oluseyi Princewill, Bonnie Marino, Ike S. Okwuosa, Jessica Chasler, Johana Almansa, Abby Cummings, et al. “Efficacy of Intravenous Furosemide Versus a Novel, pH-Neutral Furosemide Formulation Administered Subcutaneously in Outpatients With Worsening Heart Failure.JACC Heart Fail 6, no. 1 (January 2018): 65–70. https://doi.org/10.1016/j.jchf.2017.10.001.
Gilotra NA, Princewill O, Marino B, Okwuosa IS, Chasler J, Almansa J, et al. Efficacy of Intravenous Furosemide Versus a Novel, pH-Neutral Furosemide Formulation Administered Subcutaneously in Outpatients With Worsening Heart Failure. JACC Heart Fail. 2018 Jan;6(1):65–70.
Gilotra, Nisha A., et al. “Efficacy of Intravenous Furosemide Versus a Novel, pH-Neutral Furosemide Formulation Administered Subcutaneously in Outpatients With Worsening Heart Failure.JACC Heart Fail, vol. 6, no. 1, Jan. 2018, pp. 65–70. Pubmed, doi:10.1016/j.jchf.2017.10.001.
Gilotra NA, Princewill O, Marino B, Okwuosa IS, Chasler J, Almansa J, Cummings A, Rhodes P, Chambers J, Cuomo K, Russell SD. Efficacy of Intravenous Furosemide Versus a Novel, pH-Neutral Furosemide Formulation Administered Subcutaneously in Outpatients With Worsening Heart Failure. JACC Heart Fail. 2018 Jan;6(1):65–70.
Journal cover image

Published In

JACC Heart Fail

DOI

EISSN

2213-1787

Publication Date

January 2018

Volume

6

Issue

1

Start / End Page

65 / 70

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke Volume
  • Pilot Projects
  • Outpatients
  • Natriuresis
  • Middle Aged
  • Male
  • Injections, Subcutaneous
  • Injections, Intravenous
  • Hydrogen-Ion Concentration