Author + information
- Received July 19, 2017
- Revision received October 3, 2017
- Accepted October 4, 2017
- Published online December 25, 2017.
- Nisha A. Gilotra, MDa,∗ (, )
- Oluseyi Princewill, MDb,
- Bonnie Marino, RNa,
- Ike S. Okwuosa, MDa,
- Jessica Chasler, PharmDa,
- Johana Almansa, DNPa,
- Abby Cummings, CRNPa,
- Parker Rhodes, MSa,
- Julianne Chambers, RNa,
- Kimberly Cuomo, CRNPa and
- Stuart D. Russell, MDa
- aDivision of Cardiology, Department of Medicine, Johns Hopkins Hospital, Baltimore, Maryland
- bMedStar Cardiology Associates, MedStar Heart and Vascular Institute, Olney, Maryland
- ↵∗Address for correspondence:
Dr. Nisha A. Gilotra, Division of Cardiology, Department of Medicine, Johns Hopkins School of Medicine, 600 North Wolfe Street, Carnegie Building, Suite 568c, Baltimore, Maryland 21287.
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)
This investigation was supported by scPharmaceuticals. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 19, 2017.
- Revision received October 3, 2017.
- Accepted October 4, 2017.
- 2018 The Authors