Data from the AT-HOME HF study examining use of furosemide injection 8 mg/mL (Furoscix) is providing clinicians with new insights into the potential role of the agent in algorithms for people with heart failure ahead of its October 8 PDUFA date.
A phase 2 pilot study examining use of furosemide injection compared against enhanced oral diuretics for avoiding in-hospital treatment for managing congestion, results of the study indicate furosemide demonstrated augmented decongestion compared with oral diuretics and was also associated with improved quality of life.
“This small study points to a possible new way to treat patients with heart failure exacerbation without hospitalization,” said Marvin Konstam, MD, professor of medicine at Tufts University School Medicine, during his presentation at the Heart Failure Society of America (HFSA) 2022 annual scientific meeting. “The AT-HOME HF study, with limited statistical power, generated a directional favorable primary end point which was not statistically significant. There appears to be a cohesive message with statistical significance across body weight, dyspnea scores, and functional capacity, with an analogous trend in health-related quality of life.”
A phase 2, multicenter, pilot study, the AT-HOME HF study was developed to test the hypothesis that furosemide injection would be more effective than standard treatment for managing worsening congestion without the need for hospitalization based on previous data. With this in mind, the study enrolled individuals with NYHA Class 2-4 heart failure, worth recent worsening of signs and symptoms supporting the need for augmented diuresis, and these individuals were randomized in a 2:1 ratio to furosemide injection or oral medical therapy alone.
A total of 51 patients were enrolled in the study, with 34 randomized to furosemide injection and 17 randomized to standard medical therapy. Notable exclusion criteria for the study included an eGFR of 20 or less, IV loop diuretic use within the prior 24 hours, and suspected high-risk instability without patient treatment. As part of the study protocol, those randomized to furosemide injection could receive up to 7 doses during the 30-day study period, with additional doses contingent on approval by the medical monitor. Patients receiving furosemide injection were transitioned back to oral diuretics when clinically indicated.
The primary end point of the study included 4 hierarchal components. These components were cardiovascular death, heart failure hospitalization, urgent emergency department or clinic visit for heart failure with IV diuretic administration or oral diuretic enhancement, and percentage change in NT-proBNP form baseline to day 7. The study’s secondary end points included body weight, 5- and 7-point dyspnea scores, KCCQ-12 score, and 6-minute walk test.
Upon analysis, results indicated furosemide injection demonstrated augmented congestion compared with enhanced oral diuretics (Win Ratio, 1.11 [95% CI, 0.48-2.50]; P=.806). Analysis of secondary end points from the trial indicated use of furosemide injection was associated with a greater reduction in body weight from baseline to day 3 (2.8 kg vs 0.8 kg; P=.035), greater improvement from baseline to day 3 in mean 5-point dyspnea score (-0.5 vs. 0.1; P=.019), and a greater proportion of patients with markedly or moderately better shortness of breath based on 7-point dyspnea at day 3 (44% vs 6%, P=.006). Investigators also highlighted results pointed to an association between use of furosemide injection with a clinically relevant improvement from baseline to day 7 and day 30 in KCCQ-12 score as well as an increase in the average 6-minute walk distance at day 30 (36.7 vs -19.1; P=.012).
“We believe FUROSCIX (furosemide injection), if approved, represents a potential new model for the treatment of congestion in patients with heart failure by allowing IV-equivalent diuresis at home, thus potentially reducing costly hospital admissions and readmissions,” said John Tucker, chief executive officer of scPharmaceuticals, in a statement.
This study, “Avoiding Treatment in Hospital with FUROSCIX to Manage Congestion in Heart Failure (AT HOME-HF) – A Pilot Study,” were presented at HFSA 2022.