Empagliflozin Promotes Natriuresis in Diabetic Patients with Cirrhotic Refractory Ascites: A Proof-of-Concept Study

Background and aims: Interventional studies directly targeting natriuresis in refractory cirrhotic ascites are scarce, and no prospective study has examined whether sodium-glucose transporter 2 (SGLT2) inhibitor-induced glucosuria is associated with changes in renal sodium handling. We conducted a randomized, open-label, proof-of-concept study to characterize the short-term natriuretic response to empagliflozin in patients with diabetes and refractory ascites Methods: Adults with type 2 diabetes, decompensated cirrhosis, and refractory ascites were randomized 1:1 to empagliflozin 10 mg once daily plus standard care or standard care alone for 10 days. The primary outcome was the between-group difference in mean change in fractional excretion of sodium (FENa, %) from baseline (Day 0) to the mean of post-baseline Days 1, 3, 7, and 10, estimated using a linear mixed-effects model. Key secondary outcomes included 24-hour urinary sodium excretion, 24-hour urine volume, and mean daily paracentesis volume.