Osmanska, J. et al. (2023) 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, (doi: 10.1093/ehjcvp/pvad073) (PMID:37804170) (Early Online Publication)
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Abstract
Aims Subcutaneous (SC) furosemide has potential advantages over intravenous (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. We aimed to compare the bioavailability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of a new SC furosemide formulation with conventional IV furosemide and describe the first use of a bespoke mini-pump to administer this formulation. Methods and results A novel pH-neutral formulation of SC furosemide containing 80 mg furosemide in ∼2.7 mL (infused over 5 h) was investigated. The first study was a PK/PD study of SC furosemide compared with 80 mg IV furosemide administered as a bolus in ambulatory patients with heart failure (HF). The primary outcome was absolute bioavailability of SC compared with IV furosemide. The second study investigated the same SC furosemide preparation delivered by a patch infusor in patients hospitalized with HF. Primary outcome measures were treatment-emergent adverse events, infusion site pain, device performance, and PK measurements. The absolute bioavailability of SC furosemide in comparison to IV furosemide was 112%, resulting in equivalent diuresis and natriuresis. When SC furosemide was administered via the patch pump, there were no treatment-emergent adverse events and 95% of participants reported no/minor discomfort at the infusion site. Conclusion The novel preparation of SC furosemide had similar bioavailability to IV furosemide. Administration via a patch pump was feasible and well tolerated.
| Item Type: | Articles |
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| Additional Information: | This work was supported by SQ Innovation, Inc. Phase 1 PK/PD study of SC furosemide was founded by SQ Innovation, Inc. SQIN-Furosemide/abdominal device trial was funded through an investigator-initiated project grant from SQ Innovation, Inc. |
| Keywords: | Heart failure, furosemide, subcutaneous, pharmacokinetics, pharmacodynamics, intravenous. |
| Status: | Early Online Publication |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Squire, Dr Iain and McConnachie, Professor Alex and Brooksbank, Dr Katriona and Docherty, Dr Kieran and Jhund, Professor Pardeep and Petrie, Professor Mark and Kalra, Professor Paul and Gardner, Professor Roy and Wetherall, Miss Kirsty and Robertson, Dr Stacy and Osmanska, Dr Joanna and Campbell, Dr Ross and McMurray, Professor John |
| Authors: | Osmanska, J., Brooksbank, K., Docherty, K. F., Robertson, S., Wetherall, K., McConnachie, A., Hu, J., Gardner, R. S., Clark, A. L., Squire, I. B., Kalra, P. R., Jhund, P. S., Muntendam, P., McMurray, J. J.V., Petrie, M. C., and Campbell, R. T. |
| College/School: | College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing |
| Journal Name: | European Heart Journal: Cardiovascular Pharmacotherapy |
| Publisher: | Oxford University Press |
| ISSN: | 2055-6837 |
| ISSN (Online): | 2055-6845 |
| Published Online: | 06 October 2023 |
| Copyright Holders: | Copyright: © The Author(s) 2023 |
| First Published: | First published in European Heart Journal: Cardiovascular Pharmacotherapy 2023 |
| Publisher Policy: | Reproduced under a Creative Commons licence |
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