- Design
- Randomised, open-label, proof-of-concept trial
- Population
- 21 adults with type 2 diabetes, decompensated cirrhosis and refractory ascites
- Primary outcome
- Change in fractional excretion of sodium over 10 days
- Effect
- FENa +0.44 points (0.05–0.83); paracentesis −0.70 L/day (−1.17 to −0.23)
A randomised, open-label proof-of-concept study in the Journal of Gastrointestinal and Liver Diseases (26 September) gave 21 adults with type 2 diabetes, decompensated cirrhosis and refractory ascites empagliflozin 10 mg daily plus standard care, or standard care alone, for ten days.
Fractional excretion of sodium rose by 0.44 percentage points more with empagliflozin (95% CI 0.05 to 0.83). Twenty-four-hour urine sodium rose by about 92 mmol and urine volume by about 820 mL. Mean daily paracentesis volume was 0.6 L with empagliflozin against 1.3 L without (difference −0.70 L/day, −1.17 to −0.23). No serious adverse events were reported.
The mechanism is plausible and the signal consistent, which makes this worth a proper trial. But ten patients on treatment for ten days cannot establish safety in decompensated cirrhosis, where volume depletion, hepatorenal physiology and euglycaemic ketoacidosis are real risks. SGLT2 inhibitors are not established treatment for ascites, and this should not change practice outside a trial.
- Empagliflozin increased urinary sodium and reduced paracentesis volume over ten days in this pilot.
- Do not start an SGLT2 inhibitor for refractory ascites outside a trial on this evidence.
- In patients with cirrhosis already on an SGLT2 inhibitor for diabetes, watch volume status, creatinine and ketones.
- Standard management — sodium restriction, diuretics, paracentesis with albumin, TIPS assessment — is unchanged.
Why it matters
It points to a possible oral option for a condition that currently means repeated paracentesis.
Don't overread it
Ten days, 21 patients, open label: a proof of concept, not evidence of safety or benefit.
The statistics, in plain English
With 21 patients, confidence intervals are wide — the paracentesis reduction could be anywhere from 0.2 to 1.2 L a day. An open-label design means clinicians knew who got the drug, which can influence decisions like paracentesis volume.
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