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

Osmanska, Joanna; Brooksbank, Katriona; Docherty, Kieran F; Robertson, Stacy; Wetherall, Kirsty; McConnachie, Alex; Hu, Jerry; Gardner, Roy S; Clark, Andrew L; Squire, Iain B; Kalra, Paul R; Jhund, Pardeep S; Muntendam, Pieter; McMurray, John J V; Petrie, Mark C; Campbell, Ross T

doi:10.1093/ehjcvp/pvad073

Cited by 6 publications

(2 citation statements)

References 13 publications

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“…Recent data from two phase I studies indicate that subcutaneous patch infusor devices demonstrate a similar bioavailability to IV administration of furosemide [32]. In the future, this method of administration could potentially be performed at home, thereby helping to prevent and reduce hospitalizations of patients at high risk to develop AHF.…”

Section: Subcutaneous Furosemide Administrationmentioning

confidence: 99%

Decongestion in Acute Heart Failure—Time to Rethink and Standardize Current Clinical Practice?

Bilgeri,

Spitaler,

Puelacher

et al. 2024

JCM

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Most episodes of acute heart failure (AHF) are characterized by increasing signs and symptoms of congestion, manifested by edema, pleura effusion and/or ascites. Immediately and repeatedly administered intravenous (IV) loop diuretics currently represent the mainstay of initial therapy aiming to achieve adequate diuresis/natriuresis and euvolemia. Despite these efforts, a significant proportion of patients have residual congestion at discharge, which is associated with a poor prognosis. Therefore, a standardized approach is needed. The door to diuretic time should not exceed 60 min. As a general rule, the starting IV dose is 20–40 mg furosemide equivalents in loop diuretic naïve patients or double the preexisting oral home dose to be administered via IV. Monitoring responses within the following first hours are key issues. (1) After 2 h, spot urinary sodium should be ≥50–70 mmol/L. (2) After 6 h, the urine output should be ≥100–150 mL/hour. If these target measures are not reached, the guidelines currently recommend a doubling of the original dose to a maximum of 400–600 mg furosemide per day and in patients with severely impaired kidney function up to 1000 mg per day. Continuous infusion of loop diuretics offers no benefit over intermittent boluses (DOSE trial). Emerging evidence by recent randomized trials (ADVOR, CLOROTIC) supports the concept of an early combination diuretic therapy, by adding either acetazolamide (500 mg IV once daily) or hydrochlorothiazide. Acetazolamide is particularly useful in the presence of a baseline bicarbonate level of ≥27 mmol/L and remains effective in the presence of preexisting/worsening renal dysfunction but should be used only in the first three days to prevent severe metabolic disturbances. Patients should not leave the hospital when they are still congested and/or before optimized long-term guideline-directed medical therapy has been initiated. Special attention should be paid to AHF patients during the vulnerable post-discharge period, with an early follow-up visit focusing on up-titrate treatments of recommended doses within 2 weeks (STRONG-HF).

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Section: Subcutaneous Furosemide Administrationmentioning

confidence: 99%

Decongestion in Acute Heart Failure—Time to Rethink and Standardize Current Clinical Practice?

Bilgeri,

Spitaler,

Puelacher

et al. 2024

JCM

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“…SC furosemide infusions are commonly used in patients with advanced HF and palliative care needs for whom hospitalisation is unsuitable or unwanted [108]. Data from small randomised studies suggest that subcutaneous furosemide may have a similar diuretic effect to IV furosemide [109][110][111]: larger studies are planned (EudraCT 2020-004833-19) [112].…”

Section: Out-patient Parenteral Loop Diuretic Treatmentmentioning

confidence: 99%

Diuretic Treatment in Patients with Heart Failure: Current Evidence and Future Directions – Part I: Loop Diuretics

Cuthbert,

Clark

2024

Curr Heart Fail Rep

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Purpose of Review Fluid retention or congestion is a major cause of symptoms, poor quality of life, and adverse outcome in patients with heart failure (HF). Despite advances in disease-modifying therapy, the mainstay of treatment for congestion—loop diuretics—has remained largely unchanged for 50 years. In these two articles (part I: loop diuretics and part II: combination therapy), we will review the history of diuretic treatment and the current trial evidence for different diuretic strategies and explore potential future directions of research. Recent Findings We will assess recent trials including DOSE, TRANSFORM, ADVOR, CLOROTIC, OSPREY-AHF, and PUSH-AHF amongst others, and assess how these may influence current practice and future research. Summary There are few data on which to base diuretic therapy in clinical practice. The most robust evidence is for high dose loop diuretic treatment over low-dose treatment for patients admitted to hospital with HF, yet this is not reflected in guidelines. There is an urgent need for more and better research on different diuretic strategies in patients with HF.

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The Role of Subcutaneous Furosemide in Heart Failure Management: A Systematic Review

Widiarti,

Saputra,

Ariyanto

et al. 2024

Curr Cardiol Rep

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Background Acute decompensated heart failure (ADHF) patients with symptomatic congestion often require in-hospital admission for intravenous (IV) diuretic, impacting both patient well-being and healthcare expenses. Subcutaneous (SC) furosemide has a potential to facilitate outpatient management of ADHF patients. Thus, this study aims to assess the efficacy and safety of SC furosemide utilization, offering a potential alternative to traditional IV administration. Methods A systematic search was conducted until April 14 2024 across scientific databases. This review included studies comparing SC furosemide with oral and IV formulations in adult HF patients. Results This study analyzed 687 patients from 20 studies. The results demonstrate that SC furosemide can effectively manage symptomatic congestion in HF patients and results in significant cost reductions, symptom relief, and improved quality of life. Although further investigation into mortality rates is needed, SC furosemide demonstrates efficacy comparable to IV furosemide in diuresis and weight loss, with similar bioavailability and natriuretic effects. Adverse events are generally minor, predominantly related to skin irritation. Innovative strategies, such as developing isotonic alkaline solutions and improved infusion devices, are being explored to address these challenges. Conclusion SC furosemide offers a promising alternative for managing ADHF, particularly in symptomatic HF patients with volume overload. The integration of SC furosemide into routine clinical practice and future guidelines, could optimize the management of HF, reducing hospital admission and improving patient outcomes.

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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

Cited by 6 publications

References 13 publications

Decongestion in Acute Heart Failure—Time to Rethink and Standardize Current Clinical Practice?

Decongestion in Acute Heart Failure—Time to Rethink and Standardize Current Clinical Practice?

Diuretic Treatment in Patients with Heart Failure: Current Evidence and Future Directions – Part I: Loop Diuretics

The Role of Subcutaneous Furosemide in Heart Failure Management: A Systematic Review

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