Novel subcutaneous furosemide therapy safe and feasible for home-based care for patients with HF
The FDA has approved furosemide as a treatment for managing conditions characterized by excess volume and oedema resulting from congestive heart failure exacerbation, liver failure, or renal failure, including nephrotic syndrome.
A study published in the European Heart Journal - Cardiovascular Pharmacotherapy has concluded that the preparation of subcutaneous (SC) furosemide has similar bioavailability to intravenous (IV) furosemide, and the administration via a patch pump is more feasible and well tolerated.
It is already known that SC furosemide is advantageous over IV furosemide by enabling self-administration or administration by a lay caregiver, such as facilitating early discharge, preventing hospitalizations and in palliative care. A high-concentration, pH-neutral furosemide formulation has been developed for SC administration via a small patch-infusor pump.
In this study, researchers compared the bioavailability, pharmacokinetic (PK) and pharmacodynamic (PD) profile of a new SC furosemide formulation with conventional IV furosemide. They also described the first use of a bespoke mini-pump for administering this formulation.
Study findings could be summarised as:
- Researchers investigated a novel pH-neutral formulation of SC furosemide containing 80 mg furosemide in ∼2.7 mL. It was infused over five hours.
- There were two studies involved.
- IV Bolus vs SC Infusion cross-over trial: This randomized cross-over design was a PK/PD study of 80 mg IV bolus vs 80 mg SC infusion.
- SUBCUT- HF I TRIAL: This was a single dose non-comparative design. 80 mg SC infusion was done by patch pump. Diuresis: 8 hours 1700 mL; 24 hours 2548 mL and Natriuresis at 8 hours; 97 mmol/L
- The absolute bioavailability of SC furosemide in comparison to IV furosemide was 112%, resulting in equivalent diuresis and natriuresis (115% and 117%, respectively)
- When SC furosemide was administered via the patch pump, there were no treatment-emergent adverse events. 95% of participants reported no or minor discomfort at the infusion site.
Concluding further, they said, “Based on the results of our study, novel preparation of SC furosemide had similar bioavailability to IV furosemide. When administration is done via patch pump, it is feasible and well tolerated.”
Reference:
Joanna Osmanska et al. A novel, small-volume subcutaneous furosemide formulation delivered by an abdominal patch infusor device in patients with heart failure: results of two phase I studies, European Heart Journal - Cardiovascular Pharmacotherapy, 2023; pvad073,
