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RSQ-777-02: New Nasal Spray Form of Bumetanide as Effective as Oral and IV Forms in Patients Without HF or HF Risk

A new nasal spray form of bumetanide may reduce the tissue swelling caused by heart failure (HF) as effectively as the standard oral and intravenous formulations of the loop diuretic, based on findings from the RSQ-777-02 trial presented at AHA 2024 and simultaneously published in Circulation.

The study conducted from December 2023 to April 2024 included 68 adults, ages 18 to 55 years old, without HF or risk of HF prior to enrollment. Researchers administered all three forms of bumetanide (nasal, oral and intravenous) to each participant in a varied order. Of the participants, 66.2% identified as men; 60.3% self-identified as White, 27.9% as Black, and 10.3% as Asian. Additionally, 32.4% identified as Hispanic or Latino ethnicity.

Results found the nasal spray to be as safe and well-tolerated, with no significant nasal irritation, as the oral and intravenous forms of the medication. Researchers also noted that the nasal and IV forms of bumetanide had a variability in absorption of 27%, compared to >40% for the oral, pill form, suggesting that these forms are more stable routes of dosing. Additionally, compared with the oral and IV versions of bumetanide, the nasal spray form led to a similar amount of urine output.

"We were surprised by how fast the nasal spray worked and by how variable the absorption of the oral drug was even in healthy subjects," said a Daniel Bensimhon, MD, in presenting the findings. "We think this will be a valuable tool for treating [HF] by promoting care at home and potentially reducing the need for costly hospital admissions and readmissions. Keeping patients at home is good for the patient and our health systems."

The study's primary limitation is that participants were healthy and did not have HF or risk factors for developing HF at the time of enrollment. Future studies will need to evaluate the bioavailability and clinical effectiveness of intranasal bumetanide in patients with HF.

Resources

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: American Heart Association, AHA Annual Scientific Sessions, AHA24, Diuretics, Heart Failure