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Abstract: SA-PO0513

Plasma and Urine Potassium (K+) Changes After Single Subcutaneous (SC) Injection of Novel Formulation of Furosemide (FUR)

Session Information

Category: Fluid, Electrolytes, and Acid-Base Disorders

  • 1102 Fluid, Electrolyte, and Acid-Base Disorders: Clinical

Authors

  • Alcorn, Harry, Alcorn Consulting, Prior Lake, Minnesota, United States
  • Mohr, John, scPharmaceuticals Inc, Burlington, Massachusetts, United States
  • Cornelius, Barbara, scPharmaceuticals Inc, Burlington, Massachusetts, United States
  • Kamineni, Phanisyam, scPharmaceuticals Inc, Burlington, Massachusetts, United States
  • Patel, Bhavini, scPharmaceuticals Inc, Burlington, Massachusetts, United States
  • Saba, Fadi, Professional Health Care of Pinellas, St. Petersburg, Florida, United States
Background

Patients with HF and CKD are predisposed to dyskalemia due to disease process and pharmacotherapy. Loop diuretics inhibit reabsorption of Na+, Cl- and K+ which can cause hypokalemia. SCP-111 (FUR SC) is novel-formulation of FUR 80 mg/mL in development administered as 80 mg SC injection. FUR SC has equivalent bioavailability to FUR IV and similar UO and natriuresis. Purpose of analysis was to assess plasma and urinary K+ after single dose of FUR SC and FUR IV.

Methods

Post-hoc analysis from randomized, crossover study. Healthy subjects randomized 1:1 to 1 of 2 sequences (FUR IV 80 mg [two IV 40-mg boluses 2 hrs apart] or FUR SC 80 mg/mL via SC injection into abdomen). Opposite treatment administered after 3-day washout. Patients excluded if baseline serum K < 3.0 or > 5.5 mEq/L, or eGFR < 30 mL/min/1.73 m2. Blood collected pre-dose and 12 hrs post-dose to determine change in K+. Values compared between FUR SC and FUR IV using two-sample t-test of unequal variances. Urine collected for 12 hrs post-dose to determine urinary K+ excretion.

Results

21 subjects randomized; 20 and 19 had sufficient blood and urine samples for analysis, respectively. Mean (SD) difference (FUR SC- FUR IV) in plasma K+ -0.09 (0.52) mEq/L; [95% CI -0.32, 0.14]. Mean (SD) cumulative urinary K+ excretion 12 hrs post-dose 54.5 (13.9) for FUR SC, 52.6 (17.9) mEq/L for FUR IV. Cumulative urinary K+ excretion displayed in Figure 1.

Conclusion

In healthy subjects who received single dose of FUR SC and FUR IV, no statistically significant or clinically meaningful changes in plasma K+ were observed. Urinary K+ excretion was similar between groups, which mirrors previously reported UO and natriuresis. Although investigated in healthy subjects, results of analysis may provide unconfounded prediction of K+ loss after single dose to potentially aid clinical decision making in patients at risk of dyskalemia.

Funding

  • Commercial Support – scPharmaceuticals

Digital Object Identifier (DOI)