Subcutaneous Furosemide in the Treatment of Patients with Decompensated Heart Failure: Data from the Sub-Q Pilot Studies

Abstract

Introduction IV furosemide is used in most patients hospitalized with HF. A buffered formulation of furosemide delivered via an on-body subcutaneous delivery system (scPharmacauticals) that potentially would allow for treatment to be shifted to the outpatient setting was evaluated in 2 pilot studies in patients hospitalized for HF with signs and symptoms of congestion. Hypothesis Treatment with sc furosemide is a safe and feasible approach to treatment of patients with HF and congestion. Methods Patients hospitalized for HF with and congestion regardless of EF were enrolled in 2 sequential pilot studies at 5 centers. Patients requiring high doses of iv loop diuretics (> 200 mg furosemide/day) or clinical instability were excluded. The Sub-Q inpatient pilot (IP) enrolled 20 patients and treated them for 48 hours with sc furosemide (80mg sc over 5 hours given QD or BID based on need) in place of iv loop diuretics while they remained hospitalized. The Sub-Q outpatient pilot (OP) enrolled 20 patients with transition (within 24 hours) to the OP setting where they continued sc furosemide (80mg sc over 5 hours given QD or BID based on need) for up to 7 days. Data were collected on feasibility, urine output, weights, symptoms, and safety. Results In the IP, median age was 70, median EF was 39, and median Cr was 1.4 mg/dL. Patients received a mean of 2.9 treatments over 48 hours and urine output over the 2 days of treatment was 5.3 L (figure). There were 8 device issues observed. There were 4 AEs in the IP, 3 were injection site discomfort. In the OP, median age was 61, median EF was 35, and median cr was 1.4 mg/dL. Patients received a mean of 6.9 treatments over 7 days. Signs and symptoms of congestion improved in most patients, although weight did not change significantly from baseline to day 7. There were 21 device issues in 10 unique patients (mostly difficulty the filling the delivery system). There were 18 AE's (mostly mild and related to injection site discomfort). There was 1 SAE that was unrelated to study treatment. There were 2 rehospitalizations for HF over 14 days from randomization in the OP. Conclusions Treatment of selected HF patients with sc furosemide provided the anticipated effects on decongestion in both the inpatient and outpatient settings, although there were issues with the drug delivery system that limited feasibility. Ongoing developments of the delivery system for sc furosemide may make this a safe and feasible approach for treatment of congestion in the outpatient setting in selected patients.