International journal of hepatology · 2026
Natriuretic Effect of Dapagliflozin in Cirrhosis With Ascites: A Randomized, Placebo-Controlled Crossover Trial.
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Kongphakdee Nattaporn, Piewchan Setthachai, Sanpawithayakul Kanokporn, Chonprasertsuk Soonthorn, Siramolpiwat Sith
Аннотация
BACKGROUND: Ascites is a frequent complication of decompensated liver cirrhosis and is associated with a poor prognosis. Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, induces osmotic diuresis and natriuresis, with established use in heart failure. However, studies on SGLT2 inhibitors in cirrhotic patients with ascites are limited.
OBJECTIVES: The objective of this study is to evaluate changes in urine parameters in cirrhotic patients with ascites treated with dapagliflozin.
METHODS: This randomized, double-blind, placebo-controlled, crossover trial enrolled 10 patients with Child-Pugh Class B or C cirrhosis who had persistently moderate or tense ascites. Participants received dapagliflozin or placebo for 4 weeks, followed by a 2-week washout, and then crossed over to alternate treatment. The primary outcome was the change in 24-h urine sodium (UNa) excretion on Days 0, 3, and 28. Secondary outcomes included changes in 24-h urine volume (UV) and serum sodium.
RESULTS: Dapagliflozin significantly increased 24-h urinary sodium excretion at Day 3 compared with placebo (treatment difference +35.1 mmol/day; 95% CI 17.5-52.7; p < 0.001), indicating a transient natriuretic effect. This effect was not sustained at Day 28 (p = 0.42). There were no significant changes in 24-h UV or serum sodium at either time point. At the end of the dapagliflozin phase, 5 of 7 evaluable participants demonstrated improvement in ascites grade, whereas 2 did not. One serious adverse event occurred; one participant died during the washout period after completing the placebo phase due to variceal bleeding complicated by spontaneous bacterial peritonitis.
CONCLUSIONS: In cirrhotic patients with persistent ascites, dapagliflozin was associated with a transient increase in 24-h urinary sodium excretion, without significant sustained effects on urine volume or serum sodium. Dapagliflozin was generally well tolerated in this small pilot trial.
TRIAL REGISTRATION: Thai Clinical Trial Registry: TCTR20241016007.
OBJECTIVES: The objective of this study is to evaluate changes in urine parameters in cirrhotic patients with ascites treated with dapagliflozin.
METHODS: This randomized, double-blind, placebo-controlled, crossover trial enrolled 10 patients with Child-Pugh Class B or C cirrhosis who had persistently moderate or tense ascites. Participants received dapagliflozin or placebo for 4 weeks, followed by a 2-week washout, and then crossed over to alternate treatment. The primary outcome was the change in 24-h urine sodium (UNa) excretion on Days 0, 3, and 28. Secondary outcomes included changes in 24-h urine volume (UV) and serum sodium.
RESULTS: Dapagliflozin significantly increased 24-h urinary sodium excretion at Day 3 compared with placebo (treatment difference +35.1 mmol/day; 95% CI 17.5-52.7; p < 0.001), indicating a transient natriuretic effect. This effect was not sustained at Day 28 (p = 0.42). There were no significant changes in 24-h UV or serum sodium at either time point. At the end of the dapagliflozin phase, 5 of 7 evaluable participants demonstrated improvement in ascites grade, whereas 2 did not. One serious adverse event occurred; one participant died during the washout period after completing the placebo phase due to variceal bleeding complicated by spontaneous bacterial peritonitis.
CONCLUSIONS: In cirrhotic patients with persistent ascites, dapagliflozin was associated with a transient increase in 24-h urinary sodium excretion, without significant sustained effects on urine volume or serum sodium. Dapagliflozin was generally well tolerated in this small pilot trial.
TRIAL REGISTRATION: Thai Clinical Trial Registry: TCTR20241016007.