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

Nisha Gilotra, Oluseyi Princewill, Bonnie Marino, Ike S. Okwuosa, Jessica Chasler, Johana Almansa, Abby Cummings, Parker Rhodes, Julianne Chambers, Kimberly Cuomo, Stuart D. Russell

Research output: Contribution to journalArticle

Abstract

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)

Original languageEnglish (US)
Pages (from-to)65-70
Number of pages6
JournalJACC: Heart Failure
Volume6
Issue number1
DOIs
StatePublished - Jan 1 2018

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Furosemide
Outpatients
Heart Failure
Urine
Natriuresis
Diuretics
Intravenous Administration
Weight Loss
Hospitalization
Kidney
Safety
Weights and Measures
Skin
Therapeutics

Keywords

  • congestion
  • disease management
  • diuretic
  • drug delivery
  • subcutaneous

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Efficacy of Intravenous Furosemide Versus a Novel, pH-Neutral Furosemide Formulation Administered Subcutaneously in Outpatients With Worsening Heart Failure. / Gilotra, Nisha; Princewill, Oluseyi; Marino, Bonnie; Okwuosa, Ike S.; Chasler, Jessica; Almansa, Johana; Cummings, Abby; Rhodes, Parker; Chambers, Julianne; Cuomo, Kimberly; Russell, Stuart D.

In: JACC: Heart Failure, Vol. 6, No. 1, 01.01.2018, p. 65-70.

Research output: Contribution to journalArticle

Gilotra, N, Princewill, O, Marino, B, Okwuosa, IS, Chasler, J, Almansa, J, Cummings, A, Rhodes, P, Chambers, J, Cuomo, K & Russell, SD 2018, 'Efficacy of Intravenous Furosemide Versus a Novel, pH-Neutral Furosemide Formulation Administered Subcutaneously in Outpatients With Worsening Heart Failure', JACC: Heart Failure, vol. 6, no. 1, pp. 65-70. https://doi.org/10.1016/j.jchf.2017.10.001
Gilotra, Nisha ; Princewill, Oluseyi ; Marino, Bonnie ; Okwuosa, Ike S. ; Chasler, Jessica ; Almansa, Johana ; Cummings, Abby ; Rhodes, Parker ; Chambers, Julianne ; Cuomo, Kimberly ; Russell, Stuart D. / Efficacy of Intravenous Furosemide Versus a Novel, pH-Neutral Furosemide Formulation Administered Subcutaneously in Outpatients With Worsening Heart Failure. In: JACC: Heart Failure. 2018 ; Vol. 6, No. 1. pp. 65-70.
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abstract = "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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author = "Nisha Gilotra and Oluseyi Princewill and Bonnie Marino and Okwuosa, {Ike S.} and Jessica Chasler and Johana Almansa and Abby Cummings and Parker Rhodes and Julianne Chambers and Kimberly Cuomo and Russell, {Stuart D.}",
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AU - Gilotra, Nisha

AU - Princewill, Oluseyi

AU - Marino, Bonnie

AU - Okwuosa, Ike S.

AU - Chasler, Jessica

AU - Almansa, Johana

AU - Cummings, Abby

AU - Rhodes, Parker

AU - Chambers, Julianne

AU - Cuomo, Kimberly

AU - Russell, Stuart D.

PY - 2018/1/1

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N2 - 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)

AB - 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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